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Trial record 98 of 2862 for:    Pancreatic Cancer AND pancreas

Panobinostat & Bortezomib in Pancreatic Cancer Progressing on Gemcitabine Therapy

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ClinicalTrials.gov Identifier: NCT01056601
Recruitment Status : Terminated (Funding not available)
First Posted : January 26, 2010
Results First Posted : August 26, 2011
Last Update Posted : December 28, 2017
Sponsor:
Collaborators:
Novartis Pharmaceuticals
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Bortezomib
Drug: Panobinostat
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pancreatic Cancer Patients
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title Pancreatic Cancer Patients
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  57.1%
>=65 years
3
  42.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
58  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
3
  42.9%
Male
4
  57.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Progression-Free Survival
Hide Description 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.
Time Frame Up to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pancreatic Cancer Patients
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 7
Median (95% Confidence Interval)
Unit of Measure: Months
2.1
(1.7 to 2.3)
2.Secondary Outcome
Title Number of Participants by Tumor Response
Hide Description Number 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.
Time Frame Up to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pancreatic Cancer Patients
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: Participants
Progressive Disease 5
No data available 2
Objective Response 0
3.Secondary Outcome
Title Duration of Response
Hide Description Duration 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).
Time Frame Up to 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pancreatic Cancer Patients
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: Weeks
0
Time Frame Overall Study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pancreatic Cancer Patients
Hide Arm/Group Description 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.
All-Cause Mortality
Pancreatic Cancer Patients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pancreatic Cancer Patients
Affected / at Risk (%) # Events
Total   4/7 (57.14%)    
Gastrointestinal disorders   
Upper gastrointestinal hemorrhage  1  1/7 (14.29%)  1
General disorders   
Fever  1  1/7 (14.29%)  1
Investigations   
INR Increased  1  1/7 (14.29%)  1
Metabolism and nutrition disorders   
Dehyration  1  1/7 (14.29%)  1
Vascular disorders   
Thromboembolic event  1  2/7 (28.57%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pancreatic Cancer Patients
Affected / at Risk (%) # Events
Total   7/7 (100.00%)    
Blood and lymphatic system disorders   
Alkaline phosphatase increased  1  1/7 (14.29%)  1
Anemia  1  5/7 (71.43%)  6
Blood bilirubin increased  1  1/7 (14.29%)  1
GGT increased  1  1/7 (14.29%)  1
Hypoalbuminemia  1  1/7 (14.29%)  1
Hypokalemia  1  2/7 (28.57%)  2
Neutrophil count decreased  1  1/7 (14.29%)  3
Platelet count decreased  1  7/7 (100.00%)  10
White blood cell decreased  1  1/7 (14.29%)  2
Cardiac disorders   
Cardiac disorder, other  1  1/7 (14.29%)  1
Sinus tachycardia  1  1/7 (14.29%)  1
Endocrine disorders   
Edema limbs  1  2/7 (28.57%)  2
Eye disorders   
Dry eye  1  1/7 (14.29%)  1
Eye disorder, other  1  1/7 (14.29%)  1
Gastrointestinal disorders   
Anorexia  1  2/7 (28.57%)  2
Constipation  1  3/7 (42.86%)  4
Diarrhea  1  5/7 (71.43%)  6
Dry mouth  1  1/7 (14.29%)  1
Lower gastrointestinal hemorrhage  1  1/7 (14.29%)  1
Nausea  1  5/7 (71.43%)  5
Rectal hemorrhage  1  1/7 (14.29%)  1
Vomiting  1  3/7 (42.86%)  3
Weight loss  1  3/7 (42.86%)  3
General disorders   
Fatigue  1  3/7 (42.86%)  4
Metabolism and nutrition disorders   
Dehydration  1  1/7 (14.29%)  1
Nervous system disorders   
Peripheral sensory neuropathy  1  1/7 (14.29%)  1
Renal and urinary disorders   
Creatinine increased  1  2/7 (28.57%)  2
Hyperglycemia  1  1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/7 (14.29%)  1
Lung infection  1  1/7 (14.29%)  1
Skin and subcutaneous tissue disorders   
Skin ulceration  1  1/7 (14.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Study was terminated early leading to small numbers of subjects analyzed; no solid conclusion can be derived.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Arkaduisz Dudek, M.D.
Organization: Masonic Cancer Center, University of Minnesota
Phone: 612-624-0123
EMail: dudek002@umn.edu
Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01056601     History of Changes
Other Study ID Numbers: 2009LSUC012
X05302 ( Other Identifier: Millennium Pharmaceuticals, Inc. )
First Submitted: January 25, 2010
First Posted: January 26, 2010
Results First Submitted: July 28, 2011
Results First Posted: August 26, 2011
Last Update Posted: December 28, 2017