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Study of E7046 in Subjects With Selected Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT02540291
Recruitment Status : Terminated (Terminated due to, licensing agreement granting exclusive rights of research, development, manufacture and marketing of Eisai's E7046 to Adlai Nortye Biopharma.)
First Posted : September 3, 2015
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tumors
Intervention Drug: E7046
Enrollment 31
Recruitment Details Participants took part in the study at 2 sites in the United States and 1 site in France from 30 July 2015 to 27 February 2018.
Pre-assignment Details A total of 31 participants with advanced malignancies were enrolled, of which 30 participants received study treatment. The study was terminated before the start of the cohort expansion part. The discontinuation of participants from study is presented in the overall study table below.
Arm/Group Title E7046 125 mg E7046 250 mg E7046 500 mg E7046 750 mg
Hide Arm/Group Description Participants received E7046 125 milligram (mg) capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Period Title: Overall Study
Started 8 8 7 7
Completed 0 0 0 0
Not Completed 8 8 7 7
Reason Not Completed
Death             7             7             5             7
Lost to Follow-up             0             0             1             0
Withdrawal Of Consent             0             1             0             0
Study Terminated By Sponsor             1             0             0             0
Other             0             0             1             0
Arm/Group Title E7046 125 mg E7046 250 mg E7046 500 mg E7046 750 mg Total
Hide Arm/Group Description Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Total of all reporting groups
Overall Number of Baseline Participants 8 8 7 7 30
Hide Baseline Analysis Population Description
The full analysis set (FAS) included all participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 7 participants 7 participants 30 participants
51.3  (12.15) 53.0  (17.10) 54.4  (13.40) 64.4  (10.18) 55.5  (13.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 7 participants 7 participants 30 participants
Female
0
   0.0%
4
  50.0%
4
  57.1%
3
  42.9%
11
  36.7%
Male
8
 100.0%
4
  50.0%
3
  42.9%
4
  57.1%
19
  63.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 7 participants 7 participants 30 participants
Hispanic or Latino
1
  12.5%
1
  12.5%
0
   0.0%
0
   0.0%
2
   6.7%
Not Hispanic or Latino
7
  87.5%
7
  87.5%
7
 100.0%
7
 100.0%
28
  93.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 7 participants 7 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  12.5%
0
   0.0%
1
  14.3%
0
   0.0%
2
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  12.5%
0
   0.0%
1
  14.3%
1
  14.3%
3
  10.0%
White
6
  75.0%
7
  87.5%
5
  71.4%
6
  85.7%
24
  80.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
1
   3.3%
1.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who received at least 1 dose of study drug.
Arm/Group Title E7046 125 mg E7046 250 mg E7046 500 mg E7046 750 mg
Hide Arm/Group Description:
Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Overall Number of Participants Analyzed 8 8 7 7
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
8
 100.0%
7
  87.5%
6
  85.7%
7
 100.0%
SAEs
5
  62.5%
6
  75.0%
3
  42.9%
3
  42.9%
2.Primary Outcome
Title Maximum Tolerated Dose (MTD) of E7046
Hide Description [Not Specified]
Time Frame Cycle 1 (21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The dose limiting toxicity (DLT) evaluable set included all participants who were evaluable for the DLTs and had taken at least 1 dose of E7046.
Arm/Group Title E7046: All Participants
Hide Arm/Group Description:
Participants received E7046 125, 250, 500 or 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: mg
NA [1] 
[1]
MTD could not be determined due to the absence of DLTs.
3.Primary Outcome
Title Recommended Phase 2 Dose (RP2D) of E7046
Hide Description Two RP2Ds were planned to be evaluated.
Time Frame Cycle 1 (21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The DLT evaluable set included all participants who were evaluable for the DLTs and had taken at least 1 dose of E7046.
Arm/Group Title E7046: All Participants
Hide Arm/Group Description:
Participants received E7046 125 mg, 250 mg, 500 mg or 700 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: mg
RP2D 1 250
RP2D 2 500
4.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description The ORR is the percentage of participants achieving a best overall response of confirmed immune-related partial response (irPR) + immune-related complete response (irCR), according to immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) v1.1, from first dose date until disease progression/recurrence.
Time Frame From first dose date until disease progression/recurrence (approximately up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who received at least 1 dose of study drug.
Arm/Group Title E7046 125 mg E7046 250 mg E7046 500 mg E7046 750 mg
Hide Arm/Group Description:
Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Overall Number of Participants Analyzed 8 8 7 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
5.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS is defined as the time from first dose date to the date of the first documentation of confirmed disease progression or death, whichever occurs first, according to irRECIST v1.1. PFS was calculated using Kaplan-Meier product-limit method and Greenwood Formula.
Time Frame From first dose date to the date of the first documentation of confirmed disease progression or death (approximately up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who received at least 1 dose of study drug.
Arm/Group Title E7046 125 mg E7046 250 mg E7046 500 mg E7046 750 mg
Hide Arm/Group Description:
Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Overall Number of Participants Analyzed 8 8 7 7
Median (95% Confidence Interval)
Unit of Measure: months
1.5
(1.1 to 4.0)
1.4
(1.1 to 4.1)
1.3
(1.2 to 1.6)
1.3 [1] 
(0.9 to NA)
[1]
Upper limit of confidence interval could not be calculated because of high number of participants that were censored from the analysis.
6.Secondary Outcome
Title Duration of Response (DOR)
Hide Description The DOR is defined as the time from the date of first documented confirmed irCR/irPR, according to irRECIST v1.1 until the first documentation of confirmed disease progression or death, whichever came first.
Time Frame From the date of first documented confirmed irCR/irPR until the first documentation of confirmed disease progression or death (approximately up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who received at least 1 dose of study drug. No participants had irCR or irPR; therefore, the DOR could not be determined.
Arm/Group Title E7046 125 mg E7046 250 mg E7046 500 mg E7046 750 mg
Hide Arm/Group Description:
Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description The DCR is percentage of participants achieving best overall response of confirmed irCR, irPR, or immune-related stable disease (irSD) (lasting at least 5 weeks), according to irRECIST v1.1 from the first dose date until disease progression/recurrence.
Time Frame From the first dose date until disease progression/recurrence (approximately up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who received at least 1 dose of study drug.
Arm/Group Title E7046 125 mg E7046 250 mg E7046 500 mg E7046 750 mg
Hide Arm/Group Description:
Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Overall Number of Participants Analyzed 8 8 7 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.0
(3.2 to 65.1)
25.0
(3.2 to 65.1)
0
(0 to 0)
42.9
(9.9 to 81.6)
8.Secondary Outcome
Title Clinical Benefit Rate (CBR)
Hide Description The CBR is the percentage of participants achieving irPR + irCR + irSD (lasting at least 24 weeks), according to irRECIST v1.1 from first dose date until disease progression/recurrence.
Time Frame From first dose date until disease progression/recurrence (approximately up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who received at least 1 dose of study drug.
Arm/Group Title E7046 125 mg E7046 250 mg E7046 500 mg E7046 750 mg
Hide Arm/Group Description:
Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
Overall Number of Participants Analyzed 8 8 7 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Time Frame From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title E7046 125 mg E7046 250 mg E7046 500 mg E7046 750 mg
Hide Arm/Group Description Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor. Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
All-Cause Mortality
E7046 125 mg E7046 250 mg E7046 500 mg E7046 750 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/8 (87.50%)      7/8 (87.50%)      5/7 (71.43%)      7/7 (100.00%)    
Hide Serious Adverse Events
E7046 125 mg E7046 250 mg E7046 500 mg E7046 750 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/8 (62.50%)      6/8 (75.00%)      3/7 (42.86%)      3/7 (42.86%)    
Cardiac disorders         
Cardiopulmonary failure  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Myocardial infarction  1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Gastrointestinal disorders         
Abdominal pain  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 1/7 (14.29%)  1
Ascites  1  0/8 (0.00%)  0 2/8 (25.00%)  2 0/7 (0.00%)  0 0/7 (0.00%)  0
Constipation  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Duodenal stenosis  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Large intestinal obstruction  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Nausea  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Small intestinal obstruction  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Vomiting  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
General disorders         
Death  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Fatigue  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Pyrexia  1  0/8 (0.00%)  0 1/8 (12.50%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0
Hepatobiliary disorders         
Bile duct obstruction  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Hepatic function abnormal  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Immune system disorders         
Hypersensitivity  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Infections and infestations         
Pneumonia  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Investigations         
Blood bilirubin increased  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Metabolism and nutrition disorders         
Hyperuricaemia  1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Cancer pain  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Tumour haemorrhage  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Nervous system disorders         
Dysarthria  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Renal and urinary disorders         
Acute kidney injury  1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  0/8 (0.00%)  0 2/8 (25.00%)  2 0/7 (0.00%)  0 0/7 (0.00%)  0
Pleural effusion  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders         
Drug eruption  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Rash  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Rash generalised  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
E7046 125 mg E7046 250 mg E7046 500 mg E7046 750 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/8 (87.50%)      7/8 (87.50%)      6/7 (85.71%)      7/7 (100.00%)    
Blood and lymphatic system disorders         
Anaemia  1  2/8 (25.00%)  2 1/8 (12.50%)  1 3/7 (42.86%)  3 1/7 (14.29%)  1
Thrombocytopenia  1  0/8 (0.00%)  0 2/8 (25.00%)  3 0/7 (0.00%)  0 0/7 (0.00%)  0
Cardiac disorders         
Tachycardia  1  0/8 (0.00%)  0 1/8 (12.50%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0
Gastrointestinal disorders         
Abdominal distension  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 1/7 (14.29%)  1
Abdominal pain  1  0/8 (0.00%)  0 2/8 (25.00%)  2 1/7 (14.29%)  3 0/7 (0.00%)  0
Constipation  1  0/8 (0.00%)  0 1/8 (12.50%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0
Diarrhoea  1  2/8 (25.00%)  2 2/8 (25.00%)  2 3/7 (42.86%)  5 3/7 (42.86%)  4
Nausea  1  0/8 (0.00%)  0 3/8 (37.50%)  3 3/7 (42.86%)  5 3/7 (42.86%)  3
Vomiting  1  1/8 (12.50%)  1 2/8 (25.00%)  2 1/7 (14.29%)  1 2/7 (28.57%)  3
General disorders         
Chills  1  0/8 (0.00%)  0 1/8 (12.50%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0
Fatigue  1  1/8 (12.50%)  1 3/8 (37.50%)  3 3/7 (42.86%)  6 3/7 (42.86%)  3
Malaise  1  0/8 (0.00%)  0 1/8 (12.50%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0
Oedema peripheral  1  0/8 (0.00%)  0 2/8 (25.00%)  2 0/7 (0.00%)  0 0/7 (0.00%)  0
Pyrexia  1  2/8 (25.00%)  2 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Infections and infestations         
Urinary tract infection  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 1/7 (14.29%)  1
Investigations         
Blood creatinine increased  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  2
Weight decreased  1  0/8 (0.00%)  0 2/8 (25.00%)  3 0/7 (0.00%)  0 1/7 (14.29%)  1
Metabolism and nutrition disorders         
Decreased appetite  1  2/8 (25.00%)  2 2/8 (25.00%)  2 2/7 (28.57%)  4 1/7 (14.29%)  2
Dehydration  1  0/8 (0.00%)  0 1/8 (12.50%)  1 1/7 (14.29%)  1 2/7 (28.57%)  2
Hypocalcaemia  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Hypokalaemia  1  2/8 (25.00%)  3 0/8 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Hypomagnesaemia  1  0/8 (0.00%)  0 1/8 (12.50%)  2 1/7 (14.29%)  1 0/7 (0.00%)  0
Hyponatraemia  1  1/8 (12.50%)  1 1/8 (12.50%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0
Hypophosphataemia  1  0/8 (0.00%)  0 1/8 (12.50%)  2 0/7 (0.00%)  0 1/7 (14.29%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Tumour pain  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 2/7 (28.57%)  2
Nervous system disorders         
Dizziness  1  1/8 (12.50%)  1 1/8 (12.50%)  1 0/7 (0.00%)  0 1/7 (14.29%)  1
Headache  1  0/8 (0.00%)  0 3/8 (37.50%)  3 1/7 (14.29%)  1 0/7 (0.00%)  0
Psychiatric disorders         
Anxiety  1  0/8 (0.00%)  0 2/8 (25.00%)  2 0/7 (0.00%)  0 0/7 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  2/8 (25.00%)  2 0/8 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0
Dyspnoea  1  0/8 (0.00%)  0 2/8 (25.00%)  2 1/7 (14.29%)  1 0/7 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
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: Eisai Medical Information
Organization: Eisai Inc.
Phone: 1-888-274-2378
EMail: esi_oncmedinfo@eisai.com
Layout table for additonal information
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02540291    
Other Study ID Numbers: E7046-G000-101
2014-004823-37 ( EudraCT Number )
First Submitted: August 25, 2015
First Posted: September 3, 2015
Results First Submitted: February 27, 2019
Results First Posted: February 17, 2020
Last Update Posted: February 17, 2020