PII Trial Started of Pancreatic Cancer and GDC-0499
Posted: Thu Feb 11, 2010 5:26 pmhttp://clinicaltrials.gov/ct2/show/NCT01064622
Gemcitabine Hydrochloride With or Without GDC-0449 in Treating Patients With Recurrent or Metastatic Pancreatic Cancer
Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. GDC-0449 may slow the growth of tumor cells. It is not yet known whether giving gemcitabine hydrochloride together with GDC-0449 is more effective than gemcitabine hydrochloride alone in treating patients with pancreatic cancer.
PURPOSE: This randomized phase II trial is studying gemcitabine hydrochloride and GDC-0449 to see how well they work compared with gemcitabine hydrochloride alone in treating patients with recurrent or metastatic pancreatic cancer.
Estimated Enrollment: 112
Study Start Date: September 2009
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Primary Outcome Measures:
Progression-free survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
Median overall survival [ Designated as safety issue: No ]
Objective response rate [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Activity of gemcitabine hydrochloride and hedgehog antagonist GDC-0449 in patients who progress on gemcitabine hydrochloride alone [ Designated as safety issue: No ]
Prognostic ability of IHC expression or DNA alteration to determine outcome, in terms of relapse-free survival [ Designated as safety issue: No ]
Comparison of biomarker IHC levels in pancreatic cancer patients with levels in normal pancreatic samples [ Designated as safety issue: No ]
Gemcitabine Hydrochloride With or Without GDC-0449 in Treating Patients With Recurrent or Metastatic Pancreatic Cancer
Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. GDC-0449 may slow the growth of tumor cells. It is not yet known whether giving gemcitabine hydrochloride together with GDC-0449 is more effective than gemcitabine hydrochloride alone in treating patients with pancreatic cancer.
PURPOSE: This randomized phase II trial is studying gemcitabine hydrochloride and GDC-0449 to see how well they work compared with gemcitabine hydrochloride alone in treating patients with recurrent or metastatic pancreatic cancer.
Estimated Enrollment: 112
Study Start Date: September 2009
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Primary Outcome Measures:
Progression-free survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
Median overall survival [ Designated as safety issue: No ]
Objective response rate [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Activity of gemcitabine hydrochloride and hedgehog antagonist GDC-0449 in patients who progress on gemcitabine hydrochloride alone [ Designated as safety issue: No ]
Prognostic ability of IHC expression or DNA alteration to determine outcome, in terms of relapse-free survival [ Designated as safety issue: No ]
Comparison of biomarker IHC levels in pancreatic cancer patients with levels in normal pancreatic samples [ Designated as safety issue: No ]