CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 27 enrolled
Drug / intervention
cohort 1 +3 moredrug
Likely dose
GW572016 1000 or 1500 mg orally daily with gemcitabine weekly, with or without oxaliplatinAI-extracted
Key inclusion· 10
  • ✓Histologically or pathologically confirmed metastatic or locally advanced adenocarcinoma of the pancreas or biliary tree
  • ✓No prior systemic chemotherapy for metastatic or locally advanced pancreaticobiliary cancer
  • ✓No prior EGFR inhibitors
  • ✓ECOG performance status 0-2 with ability to swallow oral medications
Key exclusion· 10
  • ✕Prior treatment with GW572016 or any EGFR-targeting therapies
  • ✕Prior systemic chemotherapy for metastatic pancreaticobiliary cancer
  • ✕Evidence of brain metastases or leptomeningeal disease
  • ✕Uncontrolled intercurrent illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric illness limiting compliance

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00439179
NCT00439179Phase 1Completed
CompareCT.gov

BrUOG-PA-205 A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema GSK Study ProtocolGSK #103556

Brown University·interventional·Posted Feb 23, 2007·Updated Feb 17, 2020

In Brief

A Phase 1 clinical trial evaluating cohort 1, cohort 2, and 2 other interventions for Metastatic Pancreatic Cancer. Completed, enrolled 27 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Pancreatic Cancer
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 23, 2007
Enrollment StartJul 1, 2006
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.4 years ago

Interventions

cohort 1drug

Weekly gem + GW572016, 1000mg/day (combination)

cohort 2drug

Weekly gem + GW572016, 1500 mg/day (combination)

cohort 3drug

GEMOX + GW572016 1000 mg/day (combination)

cohort 4drug

GEMOX + GW572016 1500 mg/day (combination)