GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT00358566|
Recruitment Status : Terminated (Preliminary data showed no survival benefit in the GV1001 group compared to the gemcitabine group.)
First Posted : August 1, 2006
Last Update Posted : May 19, 2008
|Condition or disease||Intervention/treatment||Phase|
|Advanced Unresectable Pancreatic Cancer||Biological: GV1001 Drug: Gemcitabine (Chemotherapy)||Phase 3|
Pharmexa A/S has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||"Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.|
|Study Start Date :||June 2006|
|Estimated Primary Completion Date :||August 2008|
|Estimated Study Completion Date :||August 2008|
Active Comparator: Gemcitabine
Gemcitabine alone treatment.
Drug: Gemcitabine (Chemotherapy)
Gemcitabine is given as per the Burris regime and the SmPC, i.e. 7 weeks, followed by cycles of 1 weeks rest and 3 weeks chemotherapy.
Other Name: Gemzar
GV1001 in sequential combination with Gemcitabine
0.56mg GV1001 day 1, 3, 5, 8, 15, 22, week 6 and every 4 weeks thereafter. When gemcitabine is add it is given in cycles of once a week for 3 weeks and 1 week. Gemcitabine is dosed as per the SmPC.
Other Name: INN-name: Termotide
- Overall survival time [ Time Frame: 12 month ]
- Progression Free Survival [ Time Frame: Time of progression ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358566
Show 86 Study Locations
|Study Director:||Ask Aabenhus, MSc. (Pharm)||Pharmexa A/S|