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A Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00379639
First received: September 20, 2006
Last updated: July 5, 2012
Last verified: July 2012
History of Changes
Results First Received: July 5, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Interventions: Drug: Romidepsin
Drug: Gemcitabine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were assigned to 1 of 2 dose schedules concurrently on an every-other-patient basis using a "3+3" dosing scheme: Patients in Schedule A received study treatment Days 1, 8, and 15 and those in Schedule B on Days 1 and 15 of every 28-day cycle. Patients were observed for 28 days before enrollment at the next dose level, based on toxicities.

Reporting Groups
  Description
Dose Level 1 Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
Dose Level 2 Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
Dose Level 5 Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
Dose Level 6 Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
Dose Level 8 Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.

Participant Flow:   Overall Study
    Dose Level 1     Dose Level 2     Dose Level 5     Dose Level 6     Dose Level 8  
STARTED     7 [1]   7 [1]   10 [1]   6 [1]   6 [1]
Efficacy Evaluable Population     6 [2]   7 [2]   7 [2]   4 [2]   3 [2]
Completed 6 Cycles of Therapy     4     2     1     0     0  
COMPLETED     4 [3]   2 [3]   1 [3]   0 [3]   0 [3]
NOT COMPLETED     3     5     9     6     6  
Disease Progression                 3                 3                 3                 4                 4  
Physician Decision                 0                 2                 1                 1                 0  
Symptomatic Deterioration                 0                 0                 1                 0                 1  
Adverse Event                 0                 0                 1                 0                 1  
Lost to Follow-up                 0                 0                 0                 1                 0  
Other                 0                 0                 3                 0                 0  
[1] Represents the number of patients who received any amount of study drug.
[2] Completed ≥2 consecutive treatment cycles, had ≥1 efficacy assessment & no major protocol violations
[3] Represents patients who completed the study through Cycle 6



  Baseline Characteristics
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Reporting Groups
  Description
Dose Level 1 Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
Dose Level 2 Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
Dose Level 5 Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
Dose Level 6 Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
Dose Level 8 Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
Total Total of all reporting groups

Baseline Measures
    Dose Level 1     Dose Level 2     Dose Level 5     Dose Level 6     Dose Level 8     Total  
Number of Participants  
[units: participants]
 		  7     7     10     6     6     36  
Age  
[units: years]
Mean ± Standard Deviation 		  58.9  ± 11.25     53.4  ± 11.04     62.6  ± 10.86     57.3  ± 15.54     57.0  ± 13.37     58.3  ± 11.98  
Gender  
[units: participants]
 		           
Female     5     5     4     6     5     25  
Male     2     2     6     0     1     11  
Ethnicity (NIH/OMB)  
[units: participants]
 		           
Hispanic or Latino     0     0     0     0     0     0  
Not Hispanic or Latino     7     7     10     6     6     36  
Unknown or Not Reported     0     0     0     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
 		           
White     6     6     10     6     6     34  
Black     1     0     0     0     0     1  
Pakistani     0     1     0     0     0     1  
Region of Enrollment  
[units: participants]
 		           
United States     7     7     10     6     6     36  
Height  
[units: cm]
Mean ± Standard Deviation 		  169.3  ± 9.52     163.7  ± 8.13     170.9  ± 10.33     159.6  ± 4.09     164.9  ± 8.71     166.3  ± 9.21  
Weight  
[units: kg]
Mean ± Standard Deviation 		  79.8  ± 20.54     77.6  ± 25.21     73.1  ± 12.58     69.0  ± 26.84     61.7  ± 27.56     72.7  ± 21.70  
Body Surface Area (BSA)  
[units: m^2]
Mean ± Standard Deviation 		  1.9  ± 0.28     1.8  ± 0.29     1.8  ± 0.19     1.7  ± 0.23     1.7  ± 0.35     1.8  ± 0.27  



  Outcome Measures
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1.  Primary:   Number of Participants With a Dose-limiting Toxicity (DLT)   [ Time Frame: 28 days ]
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2.  Primary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: From the date of first dose to 30 days after last dose (up to 236 days). ]
  Show Outcome Measure 2

3.  Primary:   Best Overall Response   [ Time Frame: Disease assessments were performed within 4 weeks of first dose and every 8 weeks thereafter (up to 236 days). ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com


Publications of Results:


Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00379639     History of Changes
Other Study ID Numbers: GPI-06-0003
Study First Received: September 20, 2006
Results First Received: July 5, 2012
Last Updated: July 5, 2012
Health Authority: United States: Food and Drug Administration