Trial Outcomes & Findings for Panobinostat & Bortezomib in Pancreatic Cancer Progressing on Gemcitabine Therapy (NCT NCT01056601)
NCT ID: NCT01056601
Last Updated: 2017-12-28
Results Overview
Median number of months before disease progressed in patient on gemcitabine when treated with the combination of panobinostat and bortezomib. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Up to 1 Year
Results posted on
2017-12-28
Participant Flow
Participant milestones
| Measure |
Pancreatic Cancer Patients
Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m\^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
|
|---|---|
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Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Panobinostat & Bortezomib in Pancreatic Cancer Progressing on Gemcitabine Therapy
Baseline characteristics by cohort
| Measure |
Pancreatic Cancer Patients
n=7 Participants
Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m\^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 YearMedian number of months before disease progressed in patient on gemcitabine when treated with the combination of panobinostat and bortezomib. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.
Outcome measures
| Measure |
Pancreatic Cancer Patients
n=7 Participants
Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m\^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
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|---|---|
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Progression-Free Survival
|
2.1 Months
Interval 1.7 to 2.3
|
SECONDARY outcome
Timeframe: Up to 1 YearNumber of patients whose tumor has responded to study therapy is determined using Response Evaluation Criteria In Solid Tumors. Progressive Disease (PD) is assessed if the sum of the diameters has increased by ≥ 20% and ≥ 5 mm from nadir (including baseline if it is the smallest sum). Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.
Outcome measures
| Measure |
Pancreatic Cancer Patients
n=7 Participants
Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m\^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
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|---|---|
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Number of Participants by Tumor Response
Progressive Disease
|
5 Participants
|
|
Number of Participants by Tumor Response
No data available
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2 Participants
|
|
Number of Participants by Tumor Response
Objective Response
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 YearDuration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed Complete or Partial Response as defined by RECIST criteria).
Outcome measures
| Measure |
Pancreatic Cancer Patients
n=7 Participants
Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m\^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
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|---|---|
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Duration of Response
|
0 Weeks
|
Adverse Events
Pancreatic Cancer Patients
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pancreatic Cancer Patients
n=7 participants at risk
Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m\^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
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|---|---|
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Metabolism and nutrition disorders
Dehyration
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
General disorders
Fever
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Investigations
INR Increased
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Vascular disorders
Thromboembolic event
|
28.6%
2/7 • Number of events 2 • Overall Study
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
14.3%
1/7 • Number of events 1 • Overall Study
|
Other adverse events
| Measure |
Pancreatic Cancer Patients
n=7 participants at risk
Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m\^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
|
|---|---|
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Blood and lymphatic system disorders
Alkaline phosphatase increased
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Blood and lymphatic system disorders
Anemia
|
71.4%
5/7 • Number of events 6 • Overall Study
|
|
Gastrointestinal disorders
Anorexia
|
28.6%
2/7 • Number of events 2 • Overall Study
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Cardiac disorders
Cardiac disorder, other
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Gastrointestinal disorders
Constipation
|
42.9%
3/7 • Number of events 4 • Overall Study
|
|
Renal and urinary disorders
Creatinine increased
|
28.6%
2/7 • Number of events 2 • Overall Study
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Gastrointestinal disorders
Diarrhea
|
71.4%
5/7 • Number of events 6 • Overall Study
|
|
Eye disorders
Dry eye
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Endocrine disorders
Edema limbs
|
28.6%
2/7 • Number of events 2 • Overall Study
|
|
Eye disorders
Eye disorder, other
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
General disorders
Fatigue
|
42.9%
3/7 • Number of events 4 • Overall Study
|
|
Blood and lymphatic system disorders
GGT increased
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Renal and urinary disorders
Hyperglycemia
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Blood and lymphatic system disorders
Hypokalemia
|
28.6%
2/7 • Number of events 2 • Overall Study
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Gastrointestinal disorders
Nausea
|
71.4%
5/7 • Number of events 5 • Overall Study
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
14.3%
1/7 • Number of events 3 • Overall Study
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
100.0%
7/7 • Number of events 10 • Overall Study
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Cardiac disorders
Sinus tachycardia
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
14.3%
1/7 • Number of events 1 • Overall Study
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
3/7 • Number of events 3 • Overall Study
|
|
Gastrointestinal disorders
Weight loss
|
42.9%
3/7 • Number of events 3 • Overall Study
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
14.3%
1/7 • Number of events 2 • Overall Study
|
Additional Information
Arkaduisz Dudek, M.D.
Masonic Cancer Center, University of Minnesota
Phone: 612-624-0123
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place