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Gemcitabine and Pazopanib in Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01080248
Recruitment Status : Terminated (Closed due to delay by GSK)
First Posted : March 4, 2010
Results First Posted : June 9, 2015
Last Update Posted : June 9, 2015
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Gemcitabine
Drug: Pazopanib
Enrollment 2
Recruitment Details The study opened to participant enrollment on 08/26/2010 and closed to participant enrollment on 09/27/2011.
Pre-assignment Details  
Arm/Group Title Arm 1 (Gemcitabine & Pazopanib)
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Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.

Pazopanib 800 mg PO daily of each 28 day cycle.

Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Arm 1 (Gemcitabine & Pazopanib)
Hide Arm/Group Description

Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.

Pazopanib 800 mg PO daily of each 28 day 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
1
  50.0%
>=65 years
1
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Response Rate by RECIST Criteria.
Hide Description
  • Response rate = complete response + partial response per RECIST
  • Complete response - disappearance of all target and non-target lesions.
  • Partial response - at least a 30% decrease in the sum of the longest diameter of the target lesions, taking as reference the baseline sum longest diameter
Time Frame Follow-up was approximately 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was removed from study for adverse event prior to first response assessment. The remaining participant had progressive disease per RECIST while on treatment.
Arm/Group Title Arm 1 (Gemcitabine & Pazopanib)
Hide Arm/Group Description:

Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.

Pazopanib 800 mg PO daily of each 28 day cycle.

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: percentage of participants
0
2.Secondary Outcome
Title Progression-free Survival (PFS)
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  • PFS is defined as the duration of time from start of treatment to time to progression.
  • Progressive disease - at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Time Frame Follow-up was approximately 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was removed from study for adverse event prior to first response assessment.
Arm/Group Title Arm 1 (Gemcitabine & Pazopanib)
Hide Arm/Group Description:

Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.

Pazopanib 800 mg PO daily of each 28 day cycle.

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: weeks
8
3.Secondary Outcome
Title Median Survival
Hide Description [Not Specified]
Time Frame Length of follow-up was 35 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 (Gemcitabine & Pazopanib)
Hide Arm/Group Description:

Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.

Pazopanib 800 mg PO daily of each 28 day cycle.

Overall Number of Participants Analyzed 2
Median (Full Range)
Unit of Measure: weeks
34
(33 to 35)
4.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 (Gemcitabine & Pazopanib)
Hide Arm/Group Description:

Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.

Pazopanib 800 mg PO daily of each 28 day cycle.

Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 (Gemcitabine & Pazopanib)
Hide Arm/Group Description

Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.

Pazopanib 800 mg PO daily of each 28 day cycle.

All-Cause Mortality
Arm 1 (Gemcitabine & Pazopanib)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 (Gemcitabine & Pazopanib)
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%
Arm 1 (Gemcitabine & Pazopanib)
Affected / at Risk (%)
Total   2/2 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  2/2 (100.00%) 
Gastrointestinal disorders   
Bloating  1  1/2 (50.00%) 
Constipation  1  1/2 (50.00%) 
Diarrhea  1  2/2 (100.00%) 
Gastrointestinal bleed  1  1/2 (50.00%) 
Vomiting  1  1/2 (50.00%) 
General disorders   
Chills  1  2/2 (100.00%) 
Edema  1  1/2 (50.00%) 
Fatigue  1  2/2 (100.00%) 
Fever  1  1/2 (50.00%) 
Pain  1  1/2 (50.00%) 
Sweating  1  2/2 (100.00%) 
Infections and infestations   
Urinary tract infection  1  1/2 (50.00%) 
Investigations   
Alkaline phosphatase  1  1/2 (50.00%) 
SGOT/SGPT  1  2/2 (100.00%) 
Granulocytes  1  1/2 (50.00%) 
Leukopenia  1  2/2 (100.00%) 
Platelets  1  2/2 (100.00%) 
Metabolism and nutrition disorders   
Hyperglycemia  1  1/2 (50.00%) 
Hypoalbuminemia  1  1/2 (50.00%) 
Hypocalcemia  1  1/2 (50.00%) 
Hypokalemia  1  1/2 (50.00%) 
Hyponatremia  1  1/2 (50.00%) 
Nervous system disorders   
Dizziness  1  2/2 (100.00%) 
Psychiatric disorders   
Insomnia  1  1/2 (50.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/2 (50.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Joel Picus, M.D.
Organization: Washington University School of Medicine
Phone: 314-362-5740
EMail: jpicus@dom.wustl.edu
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01080248     History of Changes
Other Study ID Numbers: 10-0434 / 201103201
First Submitted: March 2, 2010
First Posted: March 4, 2010
Results First Submitted: May 4, 2015
Results First Posted: June 9, 2015
Last Update Posted: June 9, 2015