Trial Outcomes & Findings for Gemcitabine Hydrochloride With or Without Vismodegib in Treating Patients With Recurrent or Metastatic Pancreatic Cancer (NCT NCT01064622)
NCT ID: NCT01064622
Last Updated: 2024-11-19
Results Overview
Time from randomization to disease progression or death from any cause. Estimated in the two treatment groups by the Kaplan-Meier method and compared using a stratified logrank test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
118 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2024-11-19
Participant Flow
Prior to the phase II randomized trial, an open-label, lead-in phase I study was conducted with all patients receiving gemcitabine hydrochloride plus vismodegib. Seven patients were enrolled and no safety issues were identified.
Participant milestones
| Measure |
Arm I (Gemcitabine Hydrochloride and Placebo)
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO
|
Arm II (Gemcitabine Hydrochloride and Vismodegib)
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV
|
|---|---|---|
|
Lead-in Phase I
STARTED
|
0
|
7
|
|
Lead-in Phase I
COMPLETED
|
0
|
7
|
|
Lead-in Phase I
NOT COMPLETED
|
0
|
0
|
|
Randomized Phase II
STARTED
|
55
|
56
|
|
Randomized Phase II
COMPLETED
|
53
|
53
|
|
Randomized Phase II
NOT COMPLETED
|
2
|
3
|
|
Crossover of Arm I
STARTED
|
22
|
0
|
|
Crossover of Arm I
COMPLETED
|
22
|
0
|
|
Crossover of Arm I
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm I (Gemcitabine Hydrochloride and Placebo)
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO
|
Arm II (Gemcitabine Hydrochloride and Vismodegib)
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV
|
|---|---|---|
|
Randomized Phase II
Withdrawal by Subject
|
2
|
2
|
|
Randomized Phase II
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Gemcitabine Hydrochloride With or Without Vismodegib in Treating Patients With Recurrent or Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Gemcitabine Hydrochloride and Placebo)
n=53 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO
|
Arm II (Gemcitabine Hydrochloride and Vismodegib)
n=53 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV
|
Phase I lead-in Patients
n=7 Participants
Patients enrolled in the lead-in phase I portion of the trial. Patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and 150 mg vismodegib PO QD on days 1-28.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.5 years
n=5 Participants
|
64.7 years
n=7 Participants
|
56.7 years
n=5 Participants
|
64.1 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Phase I lead-in patients were not included in the efficacy analysis.
Time from randomization to disease progression or death from any cause. Estimated in the two treatment groups by the Kaplan-Meier method and compared using a stratified logrank test.
Outcome measures
| Measure |
Arm I (Gemcitabine Hydrochloride and Placebo)
n=53 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO
|
Arm II (Gemcitabine Hydrochloride and Vismodegib)
n=53 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV
|
Phase I lead-in Patients
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
|
|---|---|---|---|
|
Progression-free Survival
|
2.5 months
Interval 1.9 to 3.8
|
4.0 months
Interval 2.5 to 5.3
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Phase I lead-in patients were not included in the efficacy analysis.
Time from randomization to death from any cause. Estimated in the two treatment groups by the Kaplan-Meier method and compared using a stratified logrank test.
Outcome measures
| Measure |
Arm I (Gemcitabine Hydrochloride and Placebo)
n=53 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO
|
Arm II (Gemcitabine Hydrochloride and Vismodegib)
n=53 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV
|
Phase I lead-in Patients
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
|
|---|---|---|---|
|
Overall Survival
|
6.1 months
Interval 5.0 to 8.1
|
6.9 months
Interval 5.8 to 8.0
|
—
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Phase I lead-in patients were not included in the efficacy analysis.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm I (Gemcitabine Hydrochloride and Placebo)
n=53 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO
|
Arm II (Gemcitabine Hydrochloride and Vismodegib)
n=53 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV
|
Phase I lead-in Patients
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
|
|---|---|---|---|
|
Objective Response Rate
|
13.2 percentage of participants
Interval 5.5 to 25.3
|
7.5 percentage of participants
Interval 2.1 to 18.2
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsDetails are provided in Adverse Events section below. Reported here are percentage of patients in each arm with any grade 1 or higher adverse event, regardless of attribution.
Outcome measures
| Measure |
Arm I (Gemcitabine Hydrochloride and Placebo)
n=53 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO
|
Arm II (Gemcitabine Hydrochloride and Vismodegib)
n=53 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV
|
Phase I lead-in Patients
n=7 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
|
|---|---|---|---|
|
Incidence of Adverse Events
|
98.1 percentage of participants
Interval 89.9 to 99.9
|
98.1 percentage of participants
Interval 89.9 to 99.9
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Phase I lead-in patients were not included in the efficacy analyses.
RECIST response rate in patients after crossover from placebo to vismodegib arm. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm I (Gemcitabine Hydrochloride and Placebo)
n=22 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO
|
Arm II (Gemcitabine Hydrochloride and Vismodegib)
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV
|
Phase I lead-in Patients
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
|
|---|---|---|---|
|
Activity (Overall Response Rate) in Crossover Patients
|
4.5 percentage of participants
Interval 0.1 to 22.8
|
—
|
—
|
Adverse Events
Arm I (Gemcitabine Hydrochloride and Placebo)
Serious events: 37 serious events
Other events: 52 other events
Deaths: 0 deaths
Arm II (Gemcitabine Hydrochloride and Vismodegib)
Serious events: 22 serious events
Other events: 52 other events
Deaths: 0 deaths
Phase I lead-in Patients
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase II Crossover Patients
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Gemcitabine Hydrochloride and Placebo)
n=53 participants at risk
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO
|
Arm II (Gemcitabine Hydrochloride and Vismodegib)
n=53 participants at risk
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV
|
Phase I lead-in Patients
n=7 participants at risk
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
|
Phase II Crossover Patients
n=22 participants at risk
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Investigations
INR increased
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Ileus
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Jejunal obstruction
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Infections and infestations
Lung infection
|
1.9%
1/53 • Up to 3 years.
|
3.8%
2/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
4.5%
1/22 • Up to 3 years.
|
|
Investigations
Lymphocyte count decreased
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Nausea
|
11.3%
6/53 • Up to 3 years.
|
7.5%
4/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Nervous system disorders
Nervous system disorders - Other
|
1.9%
1/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
3.8%
2/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Infections and infestations
Skin infection
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Nervous system disorders
Stroke
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Nervous system disorders
Syncope
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Vascular disorders
Thromboembolic event
|
7.5%
4/53 • Up to 3 years.
|
3.8%
2/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Nervous system disorders
Tremor
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
11.3%
6/53 • Up to 3 years.
|
5.7%
3/53 • Up to 3 years.
|
28.6%
2/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Investigations
Weight loss
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Investigations
White blood cell decreased
|
1.9%
1/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Infections and infestations
Infection
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
4.5%
1/22 • Up to 3 years.
|
|
Investigations
Neutrophil count decreased
|
3.8%
2/53 • Up to 3 years.
|
5.7%
3/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
General disorders
Pain
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Vascular disorders
Peripheral ischemia
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Infections and infestations
Peritoneal infection
|
3.8%
2/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Investigations
Platelet count decreased
|
3.8%
2/53 • Up to 3 years.
|
5.7%
3/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Nervous system disorders
Dizziness
|
1.9%
1/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/53 • Up to 3 years.
|
3.8%
2/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
General disorders
Fatigue
|
3.8%
2/53 • Up to 3 years.
|
3.8%
2/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.9%
1/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
General disorders
Fever
|
7.5%
4/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Psychiatric disorders
Hallucinations
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.8%
2/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
4.5%
1/22 • Up to 3 years.
|
|
Vascular disorders
Hypertension
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Hepatobiliary disorders
Cholangitis
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
General disorders
Death
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
General disorders
Death due to disease progression
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Urinary tract NOS
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Blood
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Metastatic Pancreatic Cancer
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Hepatobiliary disorders
cholestasis
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
disease progression
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
General disorders
failure to thrive
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
4.5%
1/22 • Up to 3 years.
|
|
Gastrointestinal disorders
neoplasmsbenign, malignant and unspecified
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
progression of disease
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
progression of metastatic pancreatic cancer
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
progressive disease
|
0.00%
0/53 • Up to 3 years.
|
3.8%
2/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Infections and infestations
Abdominal infection
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
2/53 • Up to 3 years.
|
5.7%
3/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
1/53 • Up to 3 years.
|
3.8%
2/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Investigations
Alanine aminotransferase increased
|
5.7%
3/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/53 • Up to 3 years.
|
3.8%
2/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/53 • Up to 3 years.
|
7.5%
4/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/53 • Up to 3 years.
|
3.8%
2/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Ascites
|
1.9%
1/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Investigations
Aspartate aminotransferase increased
|
5.7%
3/53 • Up to 3 years.
|
3.8%
2/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/53 • Up to 3 years.
|
11.3%
6/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Cardiac disorders
Cardiac arrest
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Investigations
Cardiac troponin I increased
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/53 • Up to 3 years.
|
3.8%
2/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Investigations
Creatinine increased
|
1.9%
1/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
General disorders
Death NOS
|
11.3%
6/53 • Up to 3 years.
|
7.5%
4/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Infections and infestations
Device related infection
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
Other adverse events
| Measure |
Arm I (Gemcitabine Hydrochloride and Placebo)
n=53 participants at risk
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.
gemcitabine hydrochloride: Given IV
hydrocortisone/placebo: Given PO
|
Arm II (Gemcitabine Hydrochloride and Vismodegib)
n=53 participants at risk
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
vismodegib: Given PO
gemcitabine hydrochloride: Given IV
|
Phase I lead-in Patients
n=7 participants at risk
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
|
Phase II Crossover Patients
n=22 participants at risk
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
67.9%
36/53 • Up to 3 years.
|
69.8%
37/53 • Up to 3 years.
|
71.4%
5/7 • Up to 3 years.
|
54.5%
12/22 • Up to 3 years.
|
|
General disorders
Fever
|
13.2%
7/53 • Up to 3 years.
|
22.6%
12/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
18.2%
4/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Flatulence
|
9.4%
5/53 • Up to 3 years.
|
9.4%
5/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
9.4%
5/53 • Up to 3 years.
|
11.3%
6/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
General disorders
General disorders and administration site conditions - Other
|
9.4%
5/53 • Up to 3 years.
|
13.2%
7/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.8%
2/53 • Up to 3 years.
|
5.7%
3/53 • Up to 3 years.
|
28.6%
2/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Nervous system disorders
Headache
|
13.2%
7/53 • Up to 3 years.
|
18.9%
10/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.8%
2/53 • Up to 3 years.
|
5.7%
3/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
49.1%
26/53 • Up to 3 years.
|
52.8%
28/53 • Up to 3 years.
|
57.1%
4/7 • Up to 3 years.
|
50.0%
11/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.4%
5/53 • Up to 3 years.
|
13.2%
7/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.7%
3/53 • Up to 3 years.
|
1.9%
1/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Vascular disorders
Hypertension
|
3.8%
2/53 • Up to 3 years.
|
5.7%
3/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
56.6%
30/53 • Up to 3 years.
|
45.3%
24/53 • Up to 3 years.
|
28.6%
2/7 • Up to 3 years.
|
63.6%
14/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
39.6%
21/53 • Up to 3 years.
|
32.1%
17/53 • Up to 3 years.
|
42.9%
3/7 • Up to 3 years.
|
31.8%
7/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.7%
3/53 • Up to 3 years.
|
9.4%
5/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.6%
12/53 • Up to 3 years.
|
32.1%
17/53 • Up to 3 years.
|
28.6%
2/7 • Up to 3 years.
|
18.2%
4/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
22.6%
12/53 • Up to 3 years.
|
24.5%
13/53 • Up to 3 years.
|
28.6%
2/7 • Up to 3 years.
|
9.1%
2/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
39.6%
21/53 • Up to 3 years.
|
30.2%
16/53 • Up to 3 years.
|
57.1%
4/7 • Up to 3 years.
|
45.5%
10/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.3%
6/53 • Up to 3 years.
|
13.2%
7/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Vascular disorders
Hypotension
|
5.7%
3/53 • Up to 3 years.
|
7.5%
4/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
9.1%
2/22 • Up to 3 years.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/53 • Up to 3 years.
|
7.5%
4/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Psychiatric disorders
Insomnia
|
7.5%
4/53 • Up to 3 years.
|
9.4%
5/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Investigations
Investigations - Other
|
5.7%
3/53 • Up to 3 years.
|
9.4%
5/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Investigations
Lymphocyte count decreased
|
32.1%
17/53 • Up to 3 years.
|
17.0%
9/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
31.8%
7/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
5.7%
3/53 • Up to 3 years.
|
5.7%
3/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
0.00%
0/53 • Up to 3 years.
|
9.4%
5/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
9.1%
2/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Nausea
|
54.7%
29/53 • Up to 3 years.
|
54.7%
29/53 • Up to 3 years.
|
71.4%
5/7 • Up to 3 years.
|
40.9%
9/22 • Up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.9%
1/53 • Up to 3 years.
|
5.7%
3/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
11.3%
6/53 • Up to 3 years.
|
3.8%
2/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Investigations
Neutrophil count decreased
|
47.2%
25/53 • Up to 3 years.
|
52.8%
28/53 • Up to 3 years.
|
42.9%
3/7 • Up to 3 years.
|
27.3%
6/22 • Up to 3 years.
|
|
General disorders
Pain
|
11.3%
6/53 • Up to 3 years.
|
26.4%
14/53 • Up to 3 years.
|
28.6%
2/7 • Up to 3 years.
|
31.8%
7/22 • Up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.3%
6/53 • Up to 3 years.
|
18.9%
10/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
18.2%
4/22 • Up to 3 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.4%
5/53 • Up to 3 years.
|
13.2%
7/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
13.6%
3/22 • Up to 3 years.
|
|
Investigations
Platelet count decreased
|
56.6%
30/53 • Up to 3 years.
|
60.4%
32/53 • Up to 3 years.
|
85.7%
6/7 • Up to 3 years.
|
36.4%
8/22 • Up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.7%
3/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.8%
2/53 • Up to 3 years.
|
9.4%
5/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/53 • Up to 3 years.
|
5.7%
3/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
11.3%
6/53 • Up to 3 years.
|
7.5%
4/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
9.1%
2/22 • Up to 3 years.
|
|
Nervous system disorders
Syncope
|
5.7%
3/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Vascular disorders
Thromboembolic event
|
7.5%
4/53 • Up to 3 years.
|
5.7%
3/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Vascular disorders
Vascular disorders - Other
|
1.9%
1/53 • Up to 3 years.
|
5.7%
3/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
34.0%
18/53 • Up to 3 years.
|
35.8%
19/53 • Up to 3 years.
|
71.4%
5/7 • Up to 3 years.
|
22.7%
5/22 • Up to 3 years.
|
|
Investigations
Weight loss
|
18.9%
10/53 • Up to 3 years.
|
20.8%
11/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Investigations
White blood cell decreased
|
58.5%
31/53 • Up to 3 years.
|
50.9%
27/53 • Up to 3 years.
|
71.4%
5/7 • Up to 3 years.
|
40.9%
9/22 • Up to 3 years.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
General disorders
Cancer pain
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
General disorders
Death NOS
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
100.0%
7/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Dysphagia, esophagiti9s, odynophagia
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Renal and urinary disorders
Renal and urinary disorders, other
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/53 • Up to 3 years.
|
0.00%
0/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
35.8%
19/53 • Up to 3 years.
|
18.9%
10/53 • Up to 3 years.
|
42.9%
3/7 • Up to 3 years.
|
27.3%
6/22 • Up to 3 years.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/53 • Up to 3 years.
|
5.7%
3/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Investigations
Alanine aminotransferase increased
|
50.9%
27/53 • Up to 3 years.
|
52.8%
28/53 • Up to 3 years.
|
85.7%
6/7 • Up to 3 years.
|
40.9%
9/22 • Up to 3 years.
|
|
Investigations
Alkaline phosphatase increased
|
43.4%
23/53 • Up to 3 years.
|
47.2%
25/53 • Up to 3 years.
|
85.7%
6/7 • Up to 3 years.
|
50.0%
11/22 • Up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.7%
3/53 • Up to 3 years.
|
5.7%
3/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.8%
2/53 • Up to 3 years.
|
15.1%
8/53 • Up to 3 years.
|
28.6%
2/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Blood and lymphatic system disorders
Anemia
|
77.4%
41/53 • Up to 3 years.
|
75.5%
40/53 • Up to 3 years.
|
85.7%
6/7 • Up to 3 years.
|
77.3%
17/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
34.0%
18/53 • Up to 3 years.
|
37.7%
20/53 • Up to 3 years.
|
71.4%
5/7 • Up to 3 years.
|
40.9%
9/22 • Up to 3 years.
|
|
Psychiatric disorders
Anxiety
|
5.7%
3/53 • Up to 3 years.
|
5.7%
3/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/53 • Up to 3 years.
|
7.5%
4/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Ascites
|
1.9%
1/53 • Up to 3 years.
|
7.5%
4/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Investigations
Aspartate aminotransferase increased
|
54.7%
29/53 • Up to 3 years.
|
47.2%
25/53 • Up to 3 years.
|
57.1%
4/7 • Up to 3 years.
|
59.1%
13/22 • Up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.9%
10/53 • Up to 3 years.
|
17.0%
9/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
13.6%
3/22 • Up to 3 years.
|
|
Investigations
Blood bilirubin increased
|
22.6%
12/53 • Up to 3 years.
|
20.8%
11/53 • Up to 3 years.
|
28.6%
2/7 • Up to 3 years.
|
27.3%
6/22 • Up to 3 years.
|
|
General disorders
Chills
|
15.1%
8/53 • Up to 3 years.
|
11.3%
6/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/53 • Up to 3 years.
|
5.7%
3/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Constipation
|
26.4%
14/53 • Up to 3 years.
|
32.1%
17/53 • Up to 3 years.
|
71.4%
5/7 • Up to 3 years.
|
36.4%
8/22 • Up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
4/53 • Up to 3 years.
|
7.5%
4/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Investigations
Creatinine increased
|
11.3%
6/53 • Up to 3 years.
|
9.4%
5/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
13.6%
3/22 • Up to 3 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
18.9%
10/53 • Up to 3 years.
|
11.3%
6/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
9.1%
2/22 • Up to 3 years.
|
|
Psychiatric disorders
Depression
|
1.9%
1/53 • Up to 3 years.
|
9.4%
5/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
9.1%
2/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
22.6%
12/53 • Up to 3 years.
|
24.5%
13/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
13.6%
3/22 • Up to 3 years.
|
|
Nervous system disorders
Dizziness
|
7.5%
4/53 • Up to 3 years.
|
11.3%
6/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
9.1%
2/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Dry mouth
|
7.5%
4/53 • Up to 3 years.
|
5.7%
3/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Nervous system disorders
Dysgeusia
|
7.5%
4/53 • Up to 3 years.
|
22.6%
12/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
9.1%
2/22 • Up to 3 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.4%
5/53 • Up to 3 years.
|
7.5%
4/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.1%
8/53 • Up to 3 years.
|
15.1%
8/53 • Up to 3 years.
|
0.00%
0/7 • Up to 3 years.
|
13.6%
3/22 • Up to 3 years.
|
|
General disorders
Edema limbs
|
24.5%
13/53 • Up to 3 years.
|
17.0%
9/53 • Up to 3 years.
|
14.3%
1/7 • Up to 3 years.
|
0.00%
0/22 • Up to 3 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60