At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 207 enrolled

Drug / intervention

Erlotinib +1 moredrug

Likely dose

Erlotinib 150 mgfrom 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/NCT00674973

NCT00674973Phase 2Completed

Compare CT.gov

A Phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Carcinoma

Hoffmann-La Roche·interventional·Posted May 8, 2008·Updated Jun 17, 2016

In Brief

A Phase 2 clinical trial evaluating Erlotinib and Placebo for Pancreatic Cancer. Completed, enrolled 207 participants across 71 sites in 19 countries.

Detailed Summary

This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPancreatic Cancer

CountriesAustralia, Brazil, Bulgaria, Croatia, Germany, Hong Kong, India, Italy, Latvia, Lithuania, Malaysia, Mexico, Peru, Romania, Russia, Singapore, Slovenia, Ukraine, United Kingdom

Collaborators--

Timeline

Phase 2CompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedMay 2008

Enrollment StartJun 2008

Primary CompletionDec 2010

Study CompletionMar 2015

TodayJul 2026

First PostedMay 8, 2008

Enrollment StartJun 1, 2008

Primary CompletionDec 1, 2010

Study CompletionMar 1, 2015

TodayJul 2, 2026

Enrollment to primary: 2.5 yearsPosted 18.2 years ago

Interventions

Erlotinibdrug

Participants received erlotinib 150 mg tablet orally once daily.

Placebodrug

Participants received placebo matching to erlotinib 150 mg tablet orally once daily.