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A Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, or Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT02423343
Recruitment Status : Completed
First Posted : April 22, 2015
Results First Posted : September 9, 2021
Last Update Posted : September 9, 2021
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Solid Tumor
Non-Small Cell Lung Cancer Recurrent
Hepatocellular Carcinoma Recurrent
Interventions Drug: Galunisertib
Drug: Nivolumab
Enrollment 41
Recruitment Details Due low enrollment, the Hepatocellular Carcinoma (HCC) cohort was terminated early.
Pre-assignment Details Participants who had at least one post baseline tumor assessment were considered to have completed the study.
Arm/Group Title Galunisertib + Nivolumab (Cohort 1) Phase 1b Galunisertib + Nivolumab (Cohort 2) Phase 1b Galunisertib + Nivolumab (Cohort 3) Phase 1b Galunisertib + Nivolumab (Cohort 4) Phase 1b Galunisertib + Nivolumab - Non-Small Cell Lung Cancer (NSCLC) Phase 2 Galunisertib + Nivolumab - Hepatocellular Carcinoma (HCC) Phase 2
Hide Arm/Group Description 50 milligram (mg) Galunisertib administered orally daily (QD) on Day 1 through Day 14 of each 4-week cycle in combination with 3 milligrams per kilogram (3 mg/kg) nivolumab given intravenously (IV), every 2 weeks (Q2W), on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met. 50 mg Galunisertib administered orally twice daily (BID) on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met. 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met. 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met. 150 mg Galunisertib administered orally BID for the first 14 days of each 4 week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met. 150 mg Galunisertib administered orally BID for the first 14 days of each 4 week cycle in combination with 3 mg/kg nivolumab given IV, Q2W, (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Period Title: Overall Study
Started 3 5 3 4 25 1
Received at Least One Dose of Study Drug 3 5 3 4 25 1
Completed 3 4 3 4 20 1
Not Completed 0 1 0 0 5 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0             0             0
Progressive Disease             0             0             0             0             2             0
Adverse Event             0             0             0             0             2             0
Death             0             0             0             0             1             0
Arm/Group Title Galunisertib + Nivolumab (Cohort 1) Phase 1b Galunisertib + Nivolumab (Cohort 2) Phase 1b Galunisertib + Nivolumab (Cohort 3) Phase 1b Galunisertib + Nivolumab (Cohort 4) Phase 1b Galunisertib + Nivolumab - Non Small Cell Lung Cancer (NSCLC) Phase 2 Galunisertib + Nivolumab - Hepatocellular Carcinoma(HCC) Phase 2 Total
Hide Arm/Group Description 50 mg Galunisertib administered orally daily on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given intravenously (IV) every 2 weeks (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met. 50 mg Galunisertib administered orally twice daily on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met. 80 mg Galunisertib administered orally twice daily on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks(Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met. 150 mg Galunisertib administered orally twice daily on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met. 150 mg Galunisertib given orally twice daily for the first 14 days of each 4 week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met. 150 mg Galunisertib given orally twice daily for the first 14 days of each 4 week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met. Total of all reporting groups
Overall Number of Baseline Participants 3 5 3 4 25 1 41
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 5 participants 3 participants 4 participants 25 participants 1 participants 41 participants
60.7  (15.6) 47.2  (15.8) 36.0  (5.3) 61.5  (9.0) 61.0  (8.4) 64.0 [1]   (NA) 57.6  (12.1)
[1]
N =1 mean (SD) not available, individual value reported.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 3 participants 4 participants 25 participants 1 participants 41 participants
Female 1 1 1 3 9 1 16
Male 2 4 2 1 16 0 25
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 3 participants 4 participants 25 participants 1 participants 41 participants
American Indian or Alaska Native 0 0 0 0 0 0 0
Asian 0 0 0 0 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0 0
Black or African American 1 0 0 1 0 0 2
White 2 5 3 3 25 1 39
More than one race 0 0 0 0 0 0 0
Unknown or Not Reported 0 0 0 0 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 3 participants 4 participants 25 participants 1 participants 41 participants
United States 3 3 2 4 1 0 13
Spain 0 2 1 0 24 1 28
1.Primary Outcome
Title Phase 1b: Maximum Tolerated Dose (MTD) of Galunisertib in Combination With Nivolumab
Hide Description The MTD is defined as the highest tested dose that has less than 33% probability of causing a dose limiting toxicity (DLT).
Time Frame Cycle 1 through Cycle 2 (Up to 2 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug in Phase 1b per protocol.
Arm/Group Title Phase 1b Participants
Hide Arm/Group Description:

Cohort 1: 50 mg Galunisertib administered QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV, every Q2W, on Day 1 and Day 15 for 2 cycles.

Cohort 2: 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.

Cohort 3: 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.

Cohort 4: 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.

Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: milligrams (mg)
300
2.Secondary Outcome
Title Pharmacokinetics (PK): Minimum Concentration (Cmin) of Nivolumab
Hide Description Minimum Concentration (Cmin) of Nivolumab
Time Frame PK: Cycle 1 Day 15 Predose; Cycle 2: Day 1: Pre-dose; Day 15: Predose: Cycle 4: Day 1: Predose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable PK data.
Arm/Group Title Galunisertib + Nivolumab (Cohort 1) Phase 1b Galunisertib + Nivolumab (Cohort 2) Phase 1b Galunisertib + Nivolumab (Cohort 3) Phase 1b Galunisertib + Nivolumab (Cohort 4) Phase 1b Galunisertib + Nivolumab (NSCLC) Phase 2 Galunisertib + Nivolumab ( HCC) Phase 2
Hide Arm/Group Description:
50 mg Galunisertib administered orally QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every Q2W on Day 1 and Day 15 for 2 cycles.
50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.
80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.
150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles.
150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Overall Number of Participants Analyzed 2 5 3 4 11 0
Mean (Full Range)
Unit of Measure: micrograms per milliliter (µg/mL)
33.5
(19.9 to 53.6)
36.2
(11.8 to 58.1)
43.2
(5.45 to 76)
29.2
(9.39 to 63.7)
37.6
(1.08 to 105)
3.Secondary Outcome
Title PK: Area Under the Plasma Concentration -Time Curve of Galunisertib From Time Zero to 24 Hours (AUC [0-24h]) at Steady State
Hide Description Area under the plasma concentration curve from time zero to 24 hours of galunisertib for Cycle 1 and Cycle 2.
Time Frame PK: Cycle 1 and Cycle 2 Day 1: Predose, 0.5 - 3 hours postdose, Cycle 1 and Cycle 2 Day 14: Predose, 0.5 - 2, 3.5 - 5, and 24 hours postdose through Cycle 4 Day 1 predose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable PK data.
Arm/Group Title Galunisertib + Nivolumab (Cohort 1) Phase 1b Galunisertib + Nivolumab (Cohort 2) Phase 1b Galunisertib + Nivolumab (Cohort 3) Phase 1b Galunisertib + Nivolumab (Cohort 4) Phase 1b Galunisertib + Nivolumab (NSCLC ) Phase 2 Galunisertib + Nivolumab ( HCC) Phase 2
Hide Arm/Group Description:
50 mg Galunisertib administered orally QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Overall Number of Participants Analyzed 3 4 3 4 12 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms*hour per liter (μg*h/L)
3060
(41%)
2350
(46%)
2220
(164%)
5580
(61%)
7322
(67%)
NA [1] 
(NA%)
[1]
Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there was only one participant. Individual value reported: 6005 μg*h/L
4.Secondary Outcome
Title Number of Participants With Anti-Nivolumab Antibodies When Administered in Combination With Galunisertib
Hide Description Participants with treatment-emergent anti-nivolumab antibodies when administered with galunisertib were participants with a 4-fold or greater increase in titer from baseline measurement (treatment-boosted). If baseline result is ADA not present, then the subject is TE ADA+, if there is at least 1 postbaseline result of ADA present with titer ≥ 40 (treatment-induced).
Time Frame Cycle 1: Days 1, 14, 15 Predose and Day 100 Follow-up; Cycles 2 and 4: Day 1 Predose and Day 100 Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and were evaluable for TE ADA.
Arm/Group Title Galunisertib + Nivolumab (Cohort 1) Phase 1b Galunisertib + Nivolumab (Cohort 2) Phase 1b Galunisertib + Nivolumab (Cohort 3) Phase 1b Galunisertib + Nivolumab (Cohort 4) Phase 1b Galunisertib + Nivolumab (NSCLC) Phase 2 Galunisertib + Nivolumab (HCC) Phase 2
Hide Arm/Group Description:
50 mg Galunisertib administered orally QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met.
150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Overall Number of Participants Analyzed 3 5 2 3 13 1
Measure Type: Count of Participants
Unit of Measure: Participants
0 0 0 0 0 0
5.Secondary Outcome
Title Phase 2: Progression Free Survival (PFS)
Hide Description PFS was defined as the time from the date of first study treatment to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Time Frame Date of First Study Treatment to Measured Progressive Disease or Death (Up to 35 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug in the Phase 2 cohorts. Censored participants Galunisertib + Nivolumab (NSCLC) Phase 2 = 6.
Arm/Group Title Galunisertib + Nivolumab (NSCLC) Phase 2 Galunisertib + Nivolumab (HCC) Phase 2
Hide Arm/Group Description:
150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Overall Number of Participants Analyzed 25 1
Median (95% Confidence Interval)
Unit of Measure: months
5.26
(1.77 to 9.20)
5.39
6.Secondary Outcome
Title Phase 2: Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response: Objective Response Rate (ORR)
Hide Description Objective Response Rate was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
Time Frame Baseline to Measured Progressive Disease (Up to 35 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug in Phase 2 cohorts.
Arm/Group Title Galunisertib + Nivolumab (NSCLC) Phase 2 Galunisertib + Nivolumab (HCC) Phase 2
Hide Arm/Group Description:
150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Overall Number of Participants Analyzed 25 1
Measure Type: Number
Unit of Measure: Percentage of Participants
24.0 0
7.Secondary Outcome
Title Phase 2: Duration of Response (DoR)
Hide Description Duration of response was measured from the date of documented response to the date of first progression of disease or the date of death due to any cause, whichever is earlier.
Time Frame Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up to 35 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug in Phase 2 cohorts and had a response of complete response or partial response. Censored participants Galunisertib + Nivolumab (NSCLC) Phase 2 = 1.
Arm/Group Title Galunisertib + Nivolumab (NSCLC) Phase 2 Galunisertib + Nivolumab (HCC) Phase 2
Hide Arm/Group Description:
150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every 2 weeks (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Overall Number of Participants Analyzed 6 0
Median (Full Range)
Unit of Measure: months
9.03
(1.97 to 35)
8.Secondary Outcome
Title Phase 2: Time to Response
Hide Description Time to response was measured from the date of first study treatment to the first documented response of Complete Response (CR) or Partial Response (PR).
Time Frame Date of First Study Treatment to Date of Complete Response or Partial Response (Up to 35 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug in Phase 2 cohorts and had a documented response of CR or PR.
Arm/Group Title Galunisertib + Nivolumab (NSCLC) Phase 2 Galunisertib + Nivolumab (HCC) Phase 2
Hide Arm/Group Description:
150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Overall Number of Participants Analyzed 6 0
Median (Full Range)
Unit of Measure: months
4.2
(0.5 to 35)
9.Secondary Outcome
Title Phase 2: Overall Survival (OS)
Hide Description Overall Survival was determined from the date of first study treatment until death due to any cause.
Time Frame Date of First Study Treatment to Death from Any Cause (Up to 35 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug in Phase 2 cohorts. Censored participants Galunisertib + Nivolumab (NSCLC) Phase 2 = 8.
Arm/Group Title Galunisertib + Nivolumab (NSCLC) Phase 2 Galunisertib + Nivolumab (HCC) Phase 2
Hide Arm/Group Description:
150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
Overall Number of Participants Analyzed 25 1
Median (95% Confidence Interval)
Unit of Measure: months
11.99
(8.15 to 16.23)
14.52
Time Frame Up to 35 months
Adverse Event Reporting Description All participants who received at least one dose of study drug.
 
Arm/Group Title Galunisertib + Nivolumab (Cohort 1) Phase 1b Galunisertib + Nivolumab (Cohort 2) Phase 1b Galunisertib + Nivolumab (Cohort 3) Phase 1b Galunisertib + Nivolumab (Cohort 4) Phase 1b Galunisertib + Nivolumab (NSCLC) Phase 2 Galunisertib + Nivolumab (HCC) Phase 2
Hide Arm/Group Description 50 mg Galunisertib administered orally QD on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV every Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met. 50 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met. 80 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met. 150 mg Galunisertib administered orally BID on Day 1 through Day 14 of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W on Day 1 and Day 15 for 2 cycles. Participants may continue to receive study drug until discontinuation criteria are met. 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met. 150 mg Galunisertib administered orally BID for the first 14 days of each 4-week cycle in combination with 3 mg/kg nivolumab given IV Q2W (Day 1 and Day 15) of each 4-week cycle. Participants may continue to receive study drug until discontinuation criteria are met.
All-Cause Mortality
Galunisertib + Nivolumab (Cohort 1) Phase 1b Galunisertib + Nivolumab (Cohort 2) Phase 1b Galunisertib + Nivolumab (Cohort 3) Phase 1b Galunisertib + Nivolumab (Cohort 4) Phase 1b Galunisertib + Nivolumab (NSCLC) Phase 2 Galunisertib + Nivolumab (HCC) Phase 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)      4/5 (80.00%)      1/3 (33.33%)      3/4 (75.00%)      17/25 (68.00%)      1/1 (100.00%)    
Hide Serious Adverse Events
Galunisertib + Nivolumab (Cohort 1) Phase 1b Galunisertib + Nivolumab (Cohort 2) Phase 1b Galunisertib + Nivolumab (Cohort 3) Phase 1b Galunisertib + Nivolumab (Cohort 4) Phase 1b Galunisertib + Nivolumab (NSCLC) Phase 2 Galunisertib + Nivolumab (HCC) Phase 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      2/5 (40.00%)      1/3 (33.33%)      2/4 (50.00%)      13/25 (52.00%)      0/1 (0.00%)    
Cardiac disorders             
Acute myocardial infarction  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Pericarditis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Gastrointestinal disorders             
Dyspepsia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Large intestinal obstruction  1  0/3 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  2 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Small intestinal obstruction  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/25 (0.00%)  0 0/1 (0.00%)  0
Vomiting  1  1/3 (33.33%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
General disorders             
Chest pain  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Hepatobiliary disorders             
Cholestasis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Infections and infestations             
Bronchitis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Lower respiratory tract infection  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Pneumonia  1  0/3 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 3/25 (12.00%)  3 0/1 (0.00%)  0
Pyelonephritis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Respiratory tract infection  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 3/25 (12.00%)  3 0/1 (0.00%)  0
Septic shock  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Urinary tract infection  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Metabolism and nutrition disorders             
Dehydration  1  0/3 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Failure to thrive  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/25 (0.00%)  0 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/3 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Pain in extremity  1  1/3 (33.33%)  2 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Adenocarcinoma of colon  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/25 (0.00%)  0 0/1 (0.00%)  0
Nervous system disorders             
Cerebrovascular accident  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/25 (0.00%)  0 0/1 (0.00%)  0
Headache  1  0/3 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Noninfective encephalitis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  2 0/1 (0.00%)  0
Renal and urinary disorders             
Hydronephrosis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Chronic obstructive pulmonary disease  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Cough  1  1/3 (33.33%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Dyspnoea  1  1/3 (33.33%)  3 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/25 (8.00%)  2 0/1 (0.00%)  0
Respiratory failure  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Vascular disorders             
Angiopathy  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Galunisertib + Nivolumab (Cohort 1) Phase 1b Galunisertib + Nivolumab (Cohort 2) Phase 1b Galunisertib + Nivolumab (Cohort 3) Phase 1b Galunisertib + Nivolumab (Cohort 4) Phase 1b Galunisertib + Nivolumab (NSCLC) Phase 2 Galunisertib + Nivolumab (HCC) Phase 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      4/5 (80.00%)      3/3 (100.00%)      4/4 (100.00%)      23/25 (92.00%)      1/1 (100.00%)    
Blood and lymphatic system disorders             
Anaemia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  3 3/25 (12.00%)  3 0/1 (0.00%)  0
Disseminated intravascular coagulation  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Eosinophilia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  2 0/1 (0.00%)  0
Cardiac disorders             
Cardiac failure  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Mitral valve incompetence  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Pericarditis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Sinus tachycardia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  2 0/25 (0.00%)  0 0/1 (0.00%)  0
Ear and labyrinth disorders             
Tinnitus  1  0/3 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Endocrine disorders             
Hyperthyroidism  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Hypothyroidism  1  0/3 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 4/25 (16.00%)  4 0/1 (0.00%)  0
Eye disorders             
Cataract  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Dry eye  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/25 (8.00%)  2 0/1 (0.00%)  0
Gastrointestinal disorders             
Abdominal distension  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 3/25 (12.00%)  6 0/1 (0.00%)  0
Abdominal pain  1  0/3 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Cheilitis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Constipation  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 4/25 (16.00%)  5 0/1 (0.00%)  0
Diarrhoea  1  1/3 (33.33%)  1 2/5 (40.00%)  5 0/3 (0.00%)  0 1/4 (25.00%)  1 7/25 (28.00%)  10 0/1 (0.00%)  0
Dry mouth  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 4/25 (16.00%)  5 0/1 (0.00%)  0
Dyspepsia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Dysphagia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Flatulence  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/25 (8.00%)  3 0/1 (0.00%)  0
Gastrooesophageal reflux disease  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/25 (0.00%)  0 0/1 (0.00%)  0
Haematemesis  1  1/3 (33.33%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Lower gastrointestinal haemorrhage  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/25 (0.00%)  0 0/1 (0.00%)  0
Nausea  1  1/3 (33.33%)  1 1/5 (20.00%)  1 1/3 (33.33%)  1 2/4 (50.00%)  2 6/25 (24.00%)  6 0/1 (0.00%)  0
Oesophageal spasm  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Oral pain  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  2 0/1 (0.00%)  0
Rectal haemorrhage  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/25 (0.00%)  0 0/1 (0.00%)  0
Stomatitis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 3/25 (12.00%)  4 0/1 (0.00%)  0
Vomiting  1  2/3 (66.67%)  2 0/5 (0.00%)  0 1/3 (33.33%)  2 0/4 (0.00%)  0 3/25 (12.00%)  3 0/1 (0.00%)  0
General disorders             
Asthenia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 4/25 (16.00%)  5 0/1 (0.00%)  0
Chest pain  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Chills  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Fatigue  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  2 6/25 (24.00%)  10 0/1 (0.00%)  0
Influenza like illness  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  2 0/1 (0.00%)  0
Malaise  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Multiple organ dysfunction syndrome  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Non-cardiac chest pain  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  2 1/25 (4.00%)  1 0/1 (0.00%)  0
Oedema peripheral  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Pyrexia  1  1/3 (33.33%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 5/25 (20.00%)  8 0/1 (0.00%)  0
Hepatobiliary disorders             
Cholestasis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/25 (8.00%)  2 0/1 (0.00%)  0
Infections and infestations             
Cellulitis  1  0/3 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Escherichia infection  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/25 (0.00%)  0 0/1 (0.00%)  0
Gingivitis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 1/1 (100.00%)  1
Influenza  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/25 (0.00%)  0 0/1 (0.00%)  0
Otitis externa  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Otitis media  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Pneumonia  1  1/3 (33.33%)  1 0/5 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Respiratory tract infection  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 4/25 (16.00%)  4 0/1 (0.00%)  0
Rhinitis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Skin infection  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/25 (8.00%)  2 0/1 (0.00%)  0
Upper respiratory tract infection  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 4/25 (16.00%)  4 0/1 (0.00%)  0
Urinary tract infection  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 2/25 (8.00%)  4 0/1 (0.00%)  0
Injury, poisoning and procedural complications             
Infusion related reaction  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Investigations             
Alanine aminotransferase increased  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  3 2/25 (8.00%)  4 0/1 (0.00%)  0
Amylase increased  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 3/4 (75.00%)  6 2/25 (8.00%)  2 0/1 (0.00%)  0
Aspartate aminotransferase increased  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  4 2/25 (8.00%)  4 0/1 (0.00%)  0
Blood alkaline phosphatase increased  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  4 1/25 (4.00%)  1 0/1 (0.00%)  0
Blood creatinine increased  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Cd4 lymphocytes decreased  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Cystatin c increased  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Gamma-glutamyltransferase increased  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  4 2/25 (8.00%)  2 0/1 (0.00%)  0
Lipase increased  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  7 1/25 (4.00%)  1 0/1 (0.00%)  0
Lymphocyte count decreased  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  3 0/25 (0.00%)  0 0/1 (0.00%)  0
Neutrophil count decreased  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  2 0/25 (0.00%)  0 0/1 (0.00%)  0
Platelet count decreased  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  2 3/25 (12.00%)  3 0/1 (0.00%)  0
Transaminases increased  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/25 (8.00%)  2 0/1 (0.00%)  0
Troponin t increased  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Weight decreased  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  2 0/1 (0.00%)  0
White blood cell count decreased  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  3 0/25 (0.00%)  0 0/1 (0.00%)  0
Metabolism and nutrition disorders             
Cachexia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Decreased appetite  1  0/3 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 7/25 (28.00%)  11 0/1 (0.00%)  0
Dehydration  1  1/3 (33.33%)  1 1/5 (20.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Hypercalcaemia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  2 0/1 (0.00%)  0
Hyperglycaemia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  1 3/25 (12.00%)  3 0/1 (0.00%)  0
Hyperkalaemia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/25 (0.00%)  0 0/1 (0.00%)  0
Hypertriglyceridaemia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Hypoalbuminaemia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  3 0/25 (0.00%)  0 0/1 (0.00%)  0
Hypocalcaemia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  5 0/25 (0.00%)  0 0/1 (0.00%)  0
Hypokalaemia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  2 2/25 (8.00%)  2 0/1 (0.00%)  0
Hypomagnesaemia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  2 2/25 (8.00%)  2 0/1 (0.00%)  0
Hypophosphataemia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 2/25 (8.00%)  2 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/25 (8.00%)  3 0/1 (0.00%)  0
Arthritis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  8 0/1 (0.00%)  0
Back pain  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 6/25 (24.00%)  6 0/1 (0.00%)  0
Bone pain  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/25 (8.00%)  2 0/1 (0.00%)  0
Flank pain  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Gouty arthritis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Muscular weakness  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Musculoskeletal chest pain  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Musculoskeletal pain  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 1/25 (4.00%)  1 0/1 (0.00%)  0
Myalgia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/25 (0.00%)  0 0/1 (0.00%)  0
Neck pain  1  0/3 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 1/25 (4.00%)  2 0/1 (0.00%)  0
Pain in extremity  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 4/25 (16.00%)  4 0/1 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Tumour pain  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Nervous system disorders             
Aura  1  0/3 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Dizziness  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 3/25 (12.00%)  4 0/1 (0.00%)  0
Epilepsy  1  0/3 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Headache  1  0/3 (0.00%)  0 1/5 (20.00%)  1 1/3 (33.33%)  1 1/4 (25.00%)  1 5/25 (20.00%)  6 0/1 (0.00%)  0
Hypersomnia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/25 (0.00%)  0 0/1 (0.00%)  0
Neurological decompensation  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  2 0/1 (0.00%)  0
Neurological symptom  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Neuropathy peripheral  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Paraesthesia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Peripheral motor neuropathy  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/25 (8.00%)  2 0/1 (0.00%)  0
Somnolence  1  0/3 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Psychiatric disorders             
Depression  1  1/3 (33.33%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Disorientation  1  0/3 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Insomnia  1  1/3 (33.33%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 1/25 (4.00%)  1 0/1 (0.00%)  0
Renal and urinary disorders             
Acute kidney injury  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Dysuria  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Aphonia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Bronchial fistula  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Bronchospasm  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Chronic obstructive pulmonary disease  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Cough  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 3/25 (12.00%)  4 0/1 (0.00%)  0
Dysphonia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Dyspnoea  1  0/3 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 2/25 (8.00%)  2 0/1 (0.00%)  0
Haemoptysis  1  1/3 (33.33%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Oropharyngeal pain  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Pleural effusion  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Pneumonitis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/25 (8.00%)  2 0/1 (0.00%)  0
Productive cough  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Pulmonary embolism  1  0/3 (0.00%)  0 2/5 (40.00%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Respiratory acidosis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Rhinitis allergic  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Rhinorrhoea  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 1/1 (100.00%)  1
Skin and subcutaneous tissue disorders             
Dermatitis acneiform  1  1/3 (33.33%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  3 0/1 (0.00%)  0
Dry skin  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 3/25 (12.00%)  3 0/1 (0.00%)  0
Hyperhidrosis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Livedo reticularis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Pruritus  1  1/3 (33.33%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  2 9/25 (36.00%)  14 0/1 (0.00%)  0
Rash  1  0/3 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  1 2/25 (8.00%)  4 0/1 (0.00%)  0
Rash maculo-papular  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  2 5/25 (20.00%)  10 0/1 (0.00%)  0
Skin lesion  1  0/3 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
Vascular disorders             
Hot flush  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/25 (8.00%)  5 0/1 (0.00%)  0
Hypertension  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/25 (0.00%)  0 0/1 (0.00%)  0
Hypotension  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 3/25 (12.00%)  4 0/1 (0.00%)  0
Jugular vein thrombosis  1  0/3 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/25 (4.00%)  1 0/1 (0.00%)  0
Phlebitis  1  0/3 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/25 (0.00%)  0 0/1 (0.00%)  0
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Due low enrollment, the HCC cohort was terminated early.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02423343    
Other Study ID Numbers: 15702
H9H-MC-JBEF ( Other Identifier: Eli Lilly and Company )
2015-002093-20 ( EudraCT Number )
First Submitted: April 17, 2015
First Posted: April 22, 2015
Results First Submitted: July 2, 2021
Results First Posted: September 9, 2021
Last Update Posted: September 9, 2021