Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01896869
Recruitment Status : Completed
First Posted : July 11, 2013
Results First Posted : May 6, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Pancreatic Adenocarcinoma
Interventions Drug: Ipilimumab
Biological: Vaccine
Drug: FOLFIRINOX
Enrollment 83
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ipilimumab + Vaccine FOLFIRINOX
Hide Arm/Group Description

Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.

Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)

Vaccine: 5x10^8 cells administered in 6 intradermal injections

Administered every 14 days (one cycle)

FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.

Period Title: Overall Study
Started 41 42
Completed 40 36
Not Completed 1 6
Reason Not Completed
Withdrawal by Subject             0             6
Lost to Follow-up             1             0
Arm/Group Title Ipilimumab + Vaccine FOLFIRINOX Total
Hide Arm/Group Description

Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.

Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)

Vaccine: 5x10^8 cells administered in 6 intradermal injections

Administered every 14 days (one cycle)

FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.

Total of all reporting groups
Overall Number of Baseline Participants 41 42 83
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 83 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
  73.2%
26
  61.9%
56
  67.5%
>=65 years
11
  26.8%
16
  38.1%
27
  32.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 83 participants
Female
17
  41.5%
16
  38.1%
33
  39.8%
Male
24
  58.5%
26
  61.9%
50
  60.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 83 participants
Hispanic or Latino
0
   0.0%
3
   7.1%
3
   3.6%
Not Hispanic or Latino
41
 100.0%
39
  92.9%
80
  96.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 83 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   9.8%
3
   7.1%
7
   8.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   2.4%
3
   7.1%
4
   4.8%
White
36
  87.8%
36
  85.7%
72
  86.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
CA19-9 Secretors   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 83 participants
32
  78.0%
31
  73.8%
63
  75.9%
[1]
Measure Description: Carbohydrate Antigen 19-9 (CA19-9) is a tumor marker measured in the blood of patients with pancreas cancer. Not all patients with pancreas cancer will have elevated CA19-9 and there are some conditions other than cancer that can cause an elevated CA19-9. Normal CA19-9 range is 0- 36 U/mL. Individuals with elevated CA19-9 were considered secretors. Those who did not express CA19-9 were considered non-secretors.
CA19-9 at baseline   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  IU/mL
Number Analyzed 32 participants 31 participants 63 participants
185.0
(46.0 to 1091.5)
85.0
(41.6 to 178.7)
117.1
(44.7 to 372.6)
[1]
Measure Description: Carbohydrate Antigen 19-9 (CA19-9) is a tumor marker measured in the blood of patients with pancreas cancer. Not all patients with pancreas cancer will have elevated CA19-9 and there are some conditions other than cancer that can cause an elevated CA19-9. Normal CA19-9 range is 0- 36 U/mL.
[2]
Measure Analysis Population Description: Individuals who did not express CA19-9 were considered non-secretors and were excluded from analysis.
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival is the time between the date of randomization on study and death.
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
1 Arm A (Ipilimumab + Vaccine) patient was lost to follow-up prior to treatment and was excluded from analysis.
Arm/Group Title Ipilimumab + Vaccine FOLFIRINOX
Hide Arm/Group Description:

Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.

Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)

Vaccine: 5x10^8 cells administered in 6 intradermal injections

Administered every 14 days (one cycle)

FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.

Overall Number of Participants Analyzed 40 42
Median (95% Confidence Interval)
Unit of Measure: Months
9.38
(5.0 to 12.2)
14.7
(11.6 to 20.0)
2.Secondary Outcome
Title Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
Hide Description Toxicity was assessed as the number of patients experiencing study drug-related adverse events (AEs). Data reported for only study drug-related adverse events (not all adverse events as reported in the adverse events section).
Time Frame From the first dose of study drug through 70 days after last dose, up to 13 months
Hide Outcome Measure Data
Hide Analysis Population Description
AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity. Dose of Ipilimumab was reduced from 10 mg/kg to 3 mg/kg due to toxicity concerns. Toxicity rates are compared between these dosing subgroups.
Arm/Group Title 3 mg/kg 10 mg/kg
Hide Arm/Group Description:

Ipilimumab and vaccine administered every 3 weeks for 4 doses, then every 8 weeks.

Ipilimumab: 3 mg/kg administered IV

Vaccine: 5x10^8 cells administered in 6 intradermal injections

Ipilimumab and vaccine administered every 3 weeks for 4 doses, then every 8 weeks.

Ipilimumab: 10 mg/kg administered IV

Vaccine: 5x10^8 cells administered in 6 intradermal injections

Overall Number of Participants Analyzed 14 25
Measure Type: Count of Participants
Unit of Measure: Participants
Any study drug-related AE
13
  92.9%
25
 100.0%
adrenal insufficiency
0
   0.0%
1
   4.0%
alopecia
0
   0.0%
1
   4.0%
ALT increased
0
   0.0%
2
   8.0%
arthralgia
0
   0.0%
2
   8.0%
AST increased
0
   0.0%
1
   4.0%
chills
2
  14.3%
5
  20.0%
colitis
1
   7.1%
4
  16.0%
cough
0
   0.0%
1
   4.0%
diarrhea
1
   7.1%
2
   8.0%
dry mouth
0
   0.0%
1
   4.0%
dry skin
1
   7.1%
0
   0.0%
edema face
0
   0.0%
1
   4.0%
fatigue
1
   7.1%
7
  28.0%
fever
3
  21.4%
11
  44.0%
flu-like symptoms
1
   7.1%
2
   8.0%
flushing
0
   0.0%
1
   4.0%
hepatitis
0
   0.0%
1
   4.0%
hyperhidrosis
0
   0.0%
2
   8.0%
hypophysitis
1
   7.1%
2
   8.0%
hypotension
0
   0.0%
1
   4.0%
hypothyroidism
0
   0.0%
1
   4.0%
lymph node pain
0
   0.0%
2
   8.0%
lymph node swelling
0
   0.0%
1
   4.0%
malaise
1
   7.1%
0
   0.0%
myalgia
2
  14.3%
0
   0.0%
nausea
1
   7.1%
2
   8.0%
pneumonitis
0
   0.0%
1
   4.0%
pruritus
2
  14.3%
7
  28.0%
rash
8
  57.1%
18
  72.0%
swelling, chest wall mass
0
   0.0%
1
   4.0%
thyroiditis
0
   0.0%
1
   4.0%
urticaria
2
  14.3%
1
   4.0%
vomiting
1
   7.1%
2
   8.0%
weight loss
0
   0.0%
1
   4.0%
vaccine site blisters
1
   7.1%
4
  16.0%
vaccine site bruising
1
   7.1%
2
   8.0%
vaccine site erythema
11
  78.6%
20
  80.0%
vaccine site flares
0
   0.0%
2
   8.0%
vaccine site induration
12
  85.7%
25
 100.0%
vaccine site oozing
0
   0.0%
1
   4.0%
vaccine site pruritus
11
  78.6%
22
  88.0%
vaccine site scabbing
0
   0.0%
1
   4.0%
vaccine site tenderness
3
  21.4%
13
  52.0%
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Progression Free Survival is the time from date of randomization to progression or death, whichever comes first. Individuals without follow-up scans were censored one day after randomization and individuals with follow-up scans who did not have disease progression were censored at date of last scan.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
1 Arm A patient was lost to follow-up prior to treatment and was excluded from analysis.
Arm/Group Title Ipilimumab + Vaccine FOLFIRINOX
Hide Arm/Group Description:

Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.

Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)

Vaccine: 5x10^8 cells administered in 6 intradermal injections

Administered every 14 days (one cycle)

FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.

Overall Number of Participants Analyzed 40 42
Median (95% Confidence Interval)
Unit of Measure: Months
2.40
(1.87 to 2.53)
5.55
(3.32 to 8.51)
4.Secondary Outcome
Title Immune-related Progression Free Survival (irPFS)
Hide Description

Immune-related Progression Free Survival is the median time from date of randomization to disease progression or death, whichever comes first. Individuals without follow-up scans were censored one day after randomization and individuals with follow-up scans who did not have disease progression were censored at date of last scan.

Disease progression was evaluated using immune-related Response Criteria (irRC). irRC differs from RECIST primarily in that target lesions are measured in 2 dimensions and new lesions contribute to tumor burden, but do not by themselves qualify as progressive disease.

Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
1 Arm A patient was lost to follow-up prior to treatment and was excluded from analysis.
Arm/Group Title Ipilimumab + Vaccine FOLFIRINOX
Hide Arm/Group Description:

Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.

Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)

Vaccine: 5x10^8 cells administered in 6 intradermal injections

Administered every 14 days (one cycle)

FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.

Overall Number of Participants Analyzed 40 42
Median (95% Confidence Interval)
Unit of Measure: Months
2.50
(2.14 to 2.92)
5.55
(3.38 to 8.51)
5.Secondary Outcome
Title Objective Response Rate
Hide Description Objective Response Rate (ORR) is defined as the number of patients from each group achieving a Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria In Solid Tumors (RECIST).
Time Frame Assessed until disease progression, up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
6 Arm A patients were excluded from analysis (1 lost to follow-up prior to treatment, 1 off study before first follow-up scan, 4 had no measurable disease at baseline and therefore could not have a radiographic response). 13 Arm B patients were excluded from analysis (7 came off study before first follow-up scan, 6 had no measurable disease)
Arm/Group Title Ipilimumab + Vaccine FOLFIRINOX
Hide Arm/Group Description:

Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.

Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)

Vaccine: 5x10^8 cells administered in 6 intradermal injections

Administered every 14 days (one cycle)

FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.

Overall Number of Participants Analyzed 35 29
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.9%
3
  10.3%
6.Secondary Outcome
Title Immune-related Objective Response Rate
Hide Description

Immune-related Objective Response Rate (irORR) is measured the same way, except that tumor responses are evaluated using immune-related response criteria (irRC).

irRC differs from RECIST primarily in that target lesions are measured in 2 dimensions and new lesions contribute to tumor burden, but do not by themselves qualify as progressive disease.

Time Frame Assessed until disease progression, up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
6 Arm A patients were excluded from analysis (1 lost to follow-up prior to treatment, 1 off study before first follow-up scan, 4 had no measurable disease at baseline and therefore could not have a radiographic response). 13 Arm B patients were excluded from analysis (7 came off study before first follow-up scan, 6 had no measurable disease)
Arm/Group Title Ipilimumab + Vaccine FOLFIRINOX
Hide Arm/Group Description:

Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.

Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)

Vaccine: 5x10^8 cells administered in 6 intradermal injections

Administered every 14 days (one cycle)

FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.

Overall Number of Participants Analyzed 35 29
Measure Type: Count of Participants
Unit of Measure: Participants
2
   5.7%
4
  13.8%
7.Secondary Outcome
Title Duration of Response
Hide Description Average length of time between achieving a complete response (CR) or partial response (PR) and documentation of recurrent or progressive disease.
Time Frame Up to 22 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 1 patient on Arm A (Ipilimumab + Vaccine) and 3 patients on Arm B (FOLFIRINOX) achieved a response by RECIST and were included in this analysis. 2 additional patients (1 Arm A and 1 Arm B) achieved a response by irRC, but these patients were both taken off study the same day as their partial response, for disease progression by RECIST.
Arm/Group Title Ipilimumab + Vaccine FOLFIRINOX
Hide Arm/Group Description:

Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.

Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)

Vaccine: 5x10^8 cells administered in 6 intradermal injections

Administered every 14 days (one cycle)

FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.

Overall Number of Participants Analyzed 1 3
Mean (Full Range)
Unit of Measure: months
2.5
(2.5 to 2.5)
8.49
(2.73 to 17.45)
8.Secondary Outcome
Title Tumor Marker Kinetics as Assessed by Median Carbohydrate Antigen 19-9 (CA19-9) Levels
Hide Description Carbohydrate Antigen 19-9 (CA19-9) is a tumor marker measured in the blood of patients with pancreas cancer. Not all patients with pancreas cancer will have elevated CA19-9 and there are some conditions other than cancer that can cause an elevated CA19-9. Normal CA19-9 range is 0-36 U/mL.
Time Frame Baseline, Week 7, and Week 10 visits
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients who were considered CA19-9 secretors (expressed CA19-9 either on study or prior to study) were included in the analysis. 32 in Arm A (Ipilimumab+Vaccine) and 31 in Arm B (FOLFIRINOX). Only subjects evaluable for this outcome at the specified time points had CA19-9 drawn and could be included in the analysis.
Arm/Group Title Ipilimumab + Vaccine FOLFIRINOX
Hide Arm/Group Description:

Ipilimumab and vaccine administered every 3 weeks for 4 doses, then every 8 weeks.

Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)

Vaccine: 5x10^8 cells administered in 6 intradermal injections

Administered every 14 days (one cycle)

FOLFIRINOX: Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.

Overall Number of Participants Analyzed 32 31
Median (Inter-Quartile Range)
Unit of Measure: IU/mL
Baseline Number Analyzed 32 participants 31 participants
185.0
(46.0 to 1091.5)
85.0
(41.6 to 178.7)
Week 7 Number Analyzed 26 participants 21 participants
189.2
(61.2 to 7123.7)
77.9
(23.4 to 430.0)
Week 10 Number Analyzed 18 participants 15 participants
237.1
(64.4 to 4690.1)
66.8
(24.0 to 443.5)
Time Frame Adverse Events were collected from the first dose of study drug through 70 days after the last dose of study drug, up to 13 months
Adverse Event Reporting Description AEs were not collected for Arm B subjects (FOLFIRINOX). 39 Arm A subjects (Ipilimumab+Vaccine) received at least 1 dose of study drug and were evaluable for toxicity.
 
Arm/Group Title Ipilimumab + Vaccine
Hide Arm/Group Description

Ipilimumab and vaccine administered every 3 weeks for 4 doses, then every 8 weeks.

Ipilimumab: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)

Vaccine: 5x10^8 cells administered in 6 intradermal injections

All-Cause Mortality
Ipilimumab + Vaccine
Affected / at Risk (%)
Total   5/39 (12.82%) 
Hide Serious Adverse Events
Ipilimumab + Vaccine
Affected / at Risk (%)
Total   20/39 (51.28%) 
Endocrine disorders   
adrenal insufficiency *  1/39 (2.56%) 
hypophysitis *  1/39 (2.56%) 
Gastrointestinal disorders   
abdominal pain *  2/39 (5.13%) 
colitis *  3/39 (7.69%) 
diarrhea *  2/39 (5.13%) 
malabsorption *  1/39 (2.56%) 
nausea *  1/39 (2.56%) 
obstruction gastric *  1/39 (2.56%) 
vomiting *  2/39 (5.13%) 
Infections and infestations   
bacteremia *  1/39 (2.56%) 
catheter related infection *  1/39 (2.56%) 
lung infection *  2/39 (5.13%) 
sepsis *  2/39 (5.13%) 
Investigations   
alkaline phosphatase increased *  1/39 (2.56%) 
blood bilirubin increased *  2/39 (5.13%) 
INR increased *  1/39 (2.56%) 
neutropenia *  1/39 (2.56%) 
platelet count decreased *  1/39 (2.56%) 
weight loss *  1/39 (2.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
death, disease progression *  5/39 (12.82%) 
Psychiatric disorders   
delerium *  1/39 (2.56%) 
Renal and urinary disorders   
acute kidney injury *  1/39 (2.56%) 
Respiratory, thoracic and mediastinal disorders   
chest wall pain *  1/39 (2.56%) 
dyspnea *  1/39 (2.56%) 
pneumonitis *  1/39 (2.56%) 
Vascular disorders   
thromboembolic event - pulmonary embolism *  1/39 (2.56%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ipilimumab + Vaccine
Affected / at Risk (%)
Total   39/39 (100.00%) 
Blood and lymphatic system disorders   
lymph node pain *  2/39 (5.13%) 
Cardiac disorders   
sinus tachycardia *  4/39 (10.26%) 
Endocrine disorders   
hypophysitis *  3/39 (7.69%) 
Gastrointestinal disorders   
abdominal distention *  3/39 (7.69%) 
abdominal pain *  13/39 (33.33%) 
ascites *  5/39 (12.82%) 
bloating *  5/39 (12.82%) 
colitis *  4/39 (10.26%) 
constipation *  14/39 (35.90%) 
diarrhea *  12/39 (30.77%) 
dry mouth *  3/39 (7.69%) 
dyspepsia *  3/39 (7.69%) 
flatulence *  2/39 (5.13%) 
nausea *  12/39 (30.77%) 
oral pain *  2/39 (5.13%) 
vomiting *  11/39 (28.21%) 
General disorders   
chills *  12/39 (30.77%) 
cold intolerance *  2/39 (5.13%) 
edema limbs *  5/39 (12.82%) 
fatigue *  17/39 (43.59%) 
fever *  20/39 (51.28%) 
flu-like symptoms *  3/39 (7.69%) 
gait disturbance *  2/39 (5.13%) 
non-cardiac pain *  5/39 (12.82%) 
vaccine site blisters *  5/39 (12.82%) 
vaccine site bruising *  3/39 (7.69%) 
vaccine site erythema *  31/39 (79.49%) 
vaccine site flares *  2/39 (5.13%) 
vaccine site induration *  37/39 (94.87%) 
vaccine site pruritus *  33/39 (84.62%) 
vaccine site tenderness *  16/39 (41.03%) 
Infections and infestations   
upper respiratory infection *  3/39 (7.69%) 
urinary tract infection *  2/39 (5.13%) 
Injury, poisoning and procedural complications   
bruising *  4/39 (10.26%) 
fall *  2/39 (5.13%) 
pain, site of procedure/conmed *  3/39 (7.69%) 
Investigations   
alkaline phosphatase increased *  3/39 (7.69%) 
alanine aminotransferase (ALT) increased *  5/39 (12.82%) 
anemia *  4/39 (10.26%) 
aspartate aminotransferase (AST) increased *  3/39 (7.69%) 
blood bilirubin increased *  2/39 (5.13%) 
lymphocyte count decreased *  2/39 (5.13%) 
platelet count decreased *  4/39 (10.26%) 
weight loss *  5/39 (12.82%) 
Metabolism and nutrition disorders   
anorexia *  9/39 (23.08%) 
hyperglycemia *  2/39 (5.13%) 
hypokalemia *  2/39 (5.13%) 
hypophosphatemia *  2/39 (5.13%) 
Musculoskeletal and connective tissue disorders   
arthralgia *  6/39 (15.38%) 
back pain *  7/39 (17.95%) 
muscle cramp *  3/39 (7.69%) 
myalgia *  2/39 (5.13%) 
Nervous system disorders   
dizziness *  4/39 (10.26%) 
headache *  6/39 (15.38%) 
peripheral sensory neuropathy *  2/39 (5.13%) 
Psychiatric disorders   
anxiety *  7/39 (17.95%) 
depression *  3/39 (7.69%) 
insomnia *  12/39 (30.77%) 
Renal and urinary disorders   
difficulty urinating *  2/39 (5.13%) 
urinary frequency *  2/39 (5.13%) 
Reproductive system and breast disorders   
rhinitis *  2/39 (5.13%) 
Respiratory, thoracic and mediastinal disorders   
atelectasis *  4/39 (10.26%) 
cough *  6/39 (15.38%) 
dyspnea *  5/39 (12.82%) 
pleural effusion *  3/39 (7.69%) 
Skin and subcutaneous tissue disorders   
dry skin *  2/39 (5.13%) 
hyperhidrosis *  5/39 (12.82%) 
pruritus *  9/39 (23.08%) 
rash *  28/39 (71.79%) 
urticaria *  3/39 (7.69%) 
Vascular disorders   
hot flashes *  2/39 (5.13%) 
hypotension *  5/39 (12.82%) 
thromboembolic event *  3/39 (7.69%) 
*
Indicates events were collected by non-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.
The Principal Investigators (PIs) from participating sites must provide the Johns Hopkins PI with a copy of any proposed publication for review and comment at least 30 days prior to submission.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Dung Le
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 443-287-0002
EMail: dle2@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01896869    
Other Study ID Numbers: J13108
NA_00086350 ( Other Identifier: JHMIRB )
FD-R-004819-01 ( Other Grant/Funding Number: FDA OOPD )
First Submitted: July 8, 2013
First Posted: July 11, 2013
Results First Submitted: April 22, 2020
Results First Posted: May 6, 2020
Last Update Posted: May 19, 2020