CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 19 enrolled
Drug / intervention
Docetaxel +1 moredrug
Likely dose
Docetaxel 100 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/NCT02490475
NCT02490475Phase 1Completed
CompareCT.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 Docetaxel (Taxotere) in Patients With Advanced Solid Tumors

Hoffmann-La Roche·interventional·Posted Jul 3, 2015·Updated May 17, 2017

In Brief

A Phase 1 clinical trial evaluating Docetaxel 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 docetaxel (Taxotere) 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
CountriesNetherlands, United Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 3, 2015
Enrollment StartFeb 1, 2004
Primary CompletionApr 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.0 years ago

Interventions

Docetaxeldrug

Participants will receive docetaxel on Day 1 of each 3-week cycle as 60, 75, or 100 mg/m\^2 via IV infusion. 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 420 mg via IV infusion. For Cycle 1 ony, rhuMab will be administered on Day 2, at least 24 hours after docetaxel and following an initial 840-mg loading dose. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.