Clinical trialPhase 1Completed
A Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema
BrUOG-PA-205 A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema GSK Study ProtocolGSK #103556
- Outcome
- Outcome unknown
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- July 2006
- Expected end
- December 2007
- Enrollment
- 27 participants
- Sites
- 1
- Primary outcomes
- Toxicity (Number of Patients Who Experiened DLTs)
- Sponsor
- Other
- Results posted
- 2014-05-05
- Last update
- 17 February 2020
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Brief summary public domain (ClinicalTrials.gov)
A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema
Detailed description public domain (ClinicalTrials.gov)
The primary objective of this phase I study is to determine the safety, tolerability and optimal tolerated regimen of GW572016 when combined with gemcitabine and with the combination of gemcitabine and oxaliplatin. Three to six patients will be treated at each dose level to assess toxicity. To better assess the safety at the final dose level in both Stage I and Stage II, the number of patients in the cohort at the Maximum Tolerated Dose for both Stages will be expanded to 10. Therefore approximately 34-37 patients will be treated on this study. Trial finished and no further data will be collected.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Toxicity (Number of Patients Who Experiened DLTs) [until death, approximately 2 years]. Number, participants. Cohorts 1 (n=3): 0; Cohort 2 (n=11): 1; Cohort 3 (n=6): 1; Cohort 4 (n=5): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Patients Who Experienced a Partial Response [every two months until progression]. Number, participants. Cohorts 1 (n=3): 0; Cohort 2 (n=11): 2; Cohort 3 (n=6): 1; Cohort 4 (n=5): 1.