GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer
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|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|
Expanded Access : 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 ]
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): NCT00358566
|Study Director:||Ask Aabenhus, MSc. (Pharm)||Pharmexa A/S|