A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00637247|
Recruitment Status : Completed
First Posted : March 17, 2008
Results First Posted : November 30, 2010
Last Update Posted : January 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasms||Drug: imexon in combination with gemcitabine Drug: imexon placebo + gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2 Randomized, Double-Blind, Multicenter Trial of Amplimexon® Plus Gemcitabine Versus Gemcitabine Plus Placebo in Patients With Metastatic Chemotherapy Naïve Pancreatic Adenocarcinoma (Stage IV)|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||June 2010|
Experimental: imexon + gemcitabine
imexon + gemcitabine
Drug: imexon in combination with gemcitabine
875 mg/m^2 imexon IV + 1000 mg/m^2 gemcitabine IV
Other Name: Amplimexon, Gemzar
Active Comparator: Placebo + gemcitabine
Placebo in combination with gemcitabine
Drug: imexon placebo + gemcitabine
imexon placebo IV + 1000 mg/m^2 gemcitabine IV
Other Name: Gemzar
- Overall Survival for the Intent to Treat Population [ Time Frame: up to 2 years ]To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment.
- To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms [ Time Frame: up to 2 years ]
- Objective Response Rates of the Two Treatment Arms [ Time Frame: one year ]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.
- Progression Free Survival [ Time Frame: one year ]To compare the median progression free survival (PFS) of the two treatment arms. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects were censored if no documented progression had occurred at the one year time point. 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.
- One Year Survival [ Time Frame: one year ]To evaluate the 1-year survival rates of the two treatment arms.
- To Evaluate the Changes in Blood Levels of CA19.9 on the Two Treatment Arms and Whether There is a Relationship to Objective Response, and PFS [ Time Frame: one year ]
- To Evaluate the OS, ORR, PFS, 1-year Survival, and Changes in CA19.9 of Subjects on the Two Treatment Arms That Completed > 1 Cycle (28 Days) of Protocol Treatment [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637247
Show 48 Study Locations
|Study Director:||Evan Hersh, MD||AmpliMed Corporation|
|Principal Investigator:||Steven Cohen, MD||Fox Chase Cancer Center|