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Gemcitabine and CT-011 for Resected Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01313416
Recruitment Status : Terminated (Drug supply issues)
First Posted : March 11, 2011
Results First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Samir N. Khleif, Augusta University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pancreatic Neoplasms
Cancer of the Pancreas
Neoplasms Pancreatic
Pancreatic Cancer
Pancreas Cancer
Interventions Biological: CT-011
Drug: Gemcitabine
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Arm
Hide Arm/Group Description

Combination CT-011 and Gemcitabine

CT-011: 3mg/kg, intravenous (IV) day 1 of each cycle over 2 hours.

Gemcitabine: 1000mg/m^2 intravenous (IV) over 30 minutes on days 8, 15, and 22 of each cycle.

Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Single Arm
Hide Arm/Group Description

Combination CT-011 and Gemcitabine

CT-011: 3mg/kg, intravenous (IV) day 1 of each cycle over 2 hours.

Gemcitabine: 1000mg/m^2 intravenous (IV) over 30 minutes on days 8, 15, and 22 of each cycle.

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
2
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
2
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
2
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Toxicity Evaluation: From Time of First Treatment With CT-011 (Pidilizumab, MDV9300)
Hide Description

Patients presenting with symptoms possibly related to autoimmune reaction will be evaluated for organ specific autoimmune involvement, i.e:

  • Acute abdominal symptoms should be evaluated for pancreatitis, including lipase and amylase levels;
  • Persistent diarrhea should be evaluated for infection (c. diff). Any suspicion of colitis should be evaluated by a colonoscopy with biopsy.
  • Visual symptoms should be immediately evaluated by an ophthalmologist.
  • Generalized rash should be biopsied prior to local skin care, antihistamines or corticosteroids.
  • Pulmonary symptoms will be evaluated immediately, including repeated PFTs (pulmonary function tests).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study discontinued due to drug supply issues prior to analysis; no meaningful data derived.
Arm/Group Title Single Arm
Hide Arm/Group Description:

Combination CT-011 and Gemcitabine

CT-011: 3mg/kg, intravenous (IV) day 1 of each cycle over 2 hours.

Gemcitabine: 1000mg/m^2 intravenous (IV) over 30 minutes on days 8, 15, and 22 of each cycle.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Disease Response: Evaluated Using the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (v1.1)
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Patients who have received at least one cycle of therapy will be evaluated for response every 8 weeks (every other cycle). Confirmatory scans will be obtained 4 weeks following initial documentation of objective or non-target disease response.

Response will be evaluated on target and non-target lesions. The same method of assessment and same technique will be used to characterize each identified and reported lesion at baseline and during follow-up. Response will be reported as:

  • Complete Response (CR); Disappearance of all target lesions
  • Partial Response (PR); At least 30% decrease in the sum of the diameters of target lesions
  • Progressive Disease (PD): At least 20% increase in the sum of the diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.
  • Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study discontinued due to drug supply issues prior to analysis; no meaningful data derived.
Arm/Group Title Single Arm
Hide Arm/Group Description:

Combination CT-011 and Gemcitabine

CT-011: 3mg/kg, intravenous (IV) day 1 of each cycle over 2 hours.

Gemcitabine: 1000mg/m^2 intravenous (IV) over 30 minutes on days 8, 15, and 22 of each cycle.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm
Hide Arm/Group Description

Combination CT-011 and Gemcitabine

CT-011: 3mg/kg, intravenous (IV) day 1 of each cycle over 2 hours.

Gemcitabine: 1000mg/m^2 intravenous (IV) over 30 minutes on days 8, 15, and 22 of each cycle.

All-Cause Mortality
Single Arm
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm
Affected / at Risk (%)
Total   0/2 (0.00%) 
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Samir Khleif
Organization: Georgetown University
Phone: (202) 687-0100
EMail: snk48@georgetown.edu
Layout table for additonal information
Responsible Party: Samir N. Khleif, Augusta University
ClinicalTrials.gov Identifier: NCT01313416     History of Changes
Other Study ID Numbers: 11-C-0100
First Submitted: March 10, 2011
First Posted: March 11, 2011
Results First Submitted: June 18, 2019
Results First Posted: July 10, 2019
Last Update Posted: July 10, 2019