CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 98 enrolled
Drug / intervention
Gemcitabine, nab-Paclitaxel, GDC-0449drug
Likely dose
Gemcitabine, nab-Paclitaxel, GDC-0449 1000 mg/m2from 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/NCT01088815
NCT01088815Phase 2Completed
CompareCT.gov

A Phase II Study of Gemcitabine and Nab-Paclitaxel in Combination With GDC-0449 (Hedgehog Inhibitor) in Patients With Previously Untreated Metastatic Adenocarcinoma of the Pancreas

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Mar 17, 2010·Updated Apr 26, 2019

In Brief

A Phase 2 clinical trial evaluating Gemcitabine, nab-Paclitaxel, GDC-0449 for Metastatic Pancreatic Cancer. Completed, enrolled 98 participants across 3 sites.

Detailed Summary

This is an open-label, single arm, multi-center, Phase II trial to evaluate the progression free survival in patients with metastatic adenocarcinoma of the pancreas treated with a hedgehog inhibitor (GDC-0449) in combination with chemotherapy (gemcitabine and nab-Paclitaxel).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Pancreatic Cancer
CountriesUnited States
CollaboratorsStand Up To Cancer, Genentech, Inc., Celgene Corporation

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 17, 2010
Enrollment StartSep 17, 2010
Primary CompletionDec 1, 2017
Study CompletionFeb 17, 2018
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 16.3 years ago

Interventions

Gemcitabine, nab-Paclitaxel, GDC-0449drug

1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily