NCT00439179

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema

Detailed description

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.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	cohort 1	Weekly gem + GW572016, 1000mg/day (combination)
DRUG	cohort 2	Weekly gem + GW572016, 1500 mg/day (combination)
DRUG	cohort 3	GEMOX + GW572016 1000 mg/day (combination)
DRUG	cohort 4	GEMOX + GW572016 1500 mg/day (combination)

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-02-23
• Last updated: 2020-02-17
• Results posted: 2014-05-05

Locations

1 site across 1 country: United States