CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
bevacizumab [Avastin] +2 moredrug
Likely dose
bevacizumab [Avastin] 10mg/kgfrom 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/NCT00925769
NCT00925769Phase 1Completed

An Open Label Study to Evaluate the Safety and Effect on Disease Progression of Triple Combination Treatment With Erlotinib (Tarceva), Bevacizumab (Avastin), and Capecitabine (Xeloda) in Patients With Locally Advanced and/or Metastatic Pancreatic Cancer (REBECA-Trial).

Hoffmann-La Roche·interventional·Posted Jun 22, 2009·Updated Aug 7, 2015

In Brief

A Phase 1 clinical trial evaluating bevacizumab [Avastin], capecitabine [Xeloda], and 1 other intervention for Pancreatic Cancer. Completed, enrolled 32 participants across 2 sites.

Detailed Summary

This 2 part study will evaluate the safety and efficacy of a combination of Avastin, Tarceva and Xeloda (ATX) as second-line treatment in patients with locally advanced and/or metastatic pancreatic cancer. In the first part of the study, cohorts of patients will receive escalating doses of combination treatment to determine the maximum tolerated dose. The recommended dose will be used in the second part of the study to determine the efficacy of the ATX regime, in terms of its effect on disease progression. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2009
Enrollment StartJan 1, 2009
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 17.0 years ago

Interventions

bevacizumab [Avastin]drug

Escalating doses of 5/10mg/kg q2w

capecitabine [Xeloda]drug

Escalating doses of 500/650/750/900mg/m2 bid

erlotinib [Tarceva]drug

Escalating doses of 100/150mg daily