At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 19 enrolled

Drug / intervention

Capecitabine +1 moredrug

Likely dose

Capecitabine 1250 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/NCT02494596

NCT02494596Phase 1Completed

Compare CT.gov

A Phase Ib, Open-Label, Multicenter Study of the Safety and Pharmacokinetics of the Combination of RhuMab 2C4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Capecitabine (Xeloda) in Patients With Advanced Solid Tumors

Hoffmann-La Roche·interventional·Posted Jul 10, 2015·Updated Nov 10, 2015

In Brief

A Phase 1 clinical trial evaluating Capecitabine and RhuMab 2C4 for Solid Tumor. Completed, enrolled 19 participants across 2 sites in 2 countries.

Detailed Summary

This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of rhuMab 2C4(Perjeta) and capecitabine (Xeloda) in participants with advanced solid tumors that have progressed during or after standard therapy, or for which no standard therapy is available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs) in escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSolid Tumor

CountriesSpain, United Kingdom

Collaborators--

Timeline

Phase 1CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJan 2004

Primary CompletionSep 2005

First PostedJul 2015

TodayJul 2026

First PostedJul 10, 2015

Enrollment StartJan 1, 2004

Primary CompletionSep 1, 2005

TodayJul 2, 2026

Enrollment to primary: 1.7 yearsPosted 11.0 years ago

Interventions

Capecitabinedrug

Participants will receive capecitabine on Days 1 to 14 of each 3-week cycle as 825, 1000, or 1250 mg/m\^2 PO twice daily. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.

RhuMab 2C4drug

Participants will receive rhuMab 2C4 on Day 1 of each 3-week cycle as 1050 mg via IV infusion. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.