CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 118 enrolled
Drug / intervention
Gemcitabine Hydrochloride +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01064622
NCT01064622Phase 2Completed

A Multi-center, Double Blind, Placebo-Controlled, Randomized Phase II Trial of Gemcitabine Plus GDC-0449 (NSC 747691), a Hh Pathway Inhibitor, in Patients With Metastatic Pancreatic Cancer (10052747)

National Cancer Institute (NCI)·interventional·Posted Feb 8, 2010·Updated Nov 19, 2024

In Brief

A Phase 2 clinical trial evaluating Gemcitabine Hydrochloride, Hydrocortisone/Placebo, and 1 other intervention for Pancreatic Adenocarcinoma and 2 related conditions. Completed, enrolled 118 participants across 25 sites.

Detailed Summary

This randomized phase I/II trial studies gemcitabine hydrochloride and vismodegib to see how well they work compared with gemcitabine hydrochloride alone in treating patients with recurrent or metastatic pancreatic cancer. 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. Vismodegib may slow the growth of tumor cells. It is not yet known whether giving gemcitabine hydrochloride together with vismodegib is more effective than gemcitabine hydrochloride alone in treating patients with pancreatic cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2010
Enrollment StartSep 3, 2009
Primary CompletionDec 9, 2012
Study CompletionJan 31, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.4 years ago

Interventions

Gemcitabine Hydrochloridedrug

Given IV

Hydrocortisone/Placeboother

Given PO

Vismodegibdrug

Given PO