CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 99 enrolled
Drug / intervention
Temsirolimus +1 moredrug
Likely dose
Temsirolimus 8 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/NCT01111825
NCT01111825Phase 2Completed
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A Phase I/II Trial of Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer

Puma Biotechnology, Inc.·interventional·Posted Apr 28, 2010·Updated Sep 26, 2018

In Brief

A Phase 2 clinical trial evaluating Temsirolimus and Neratinib for Breast Cancer. Completed, enrolled 99 participants across 12 sites in 6 countries.

Detailed Summary

This is an open-label, single arm, multi-center, multi-national, adaptive design, dose-escalation Phase 1/2 study to determine the maximum tolerated dose (MTD) of temsirolimus with daily neratinib, and to determine the safety and efficacy of this combination when given to patients with advanced breast carcinoma, specifically trastuzumab-refractory HER2-amplified disease or triple-negative disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesDenmark, France, Hong Kong, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 28, 2010
Enrollment StartApr 1, 2010
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 16.2 years ago

Interventions

Temsirolimusdrug

28 day treatment cycle Phase 1 * Weekly intravenously (IV) on days 1, 8, 15, and 22 * Starting dose 8 mg IV weekly (dose level 1). Three patients initially enrolled in each cohort Phase 2 * Dose escalation cohort - 8 mg IV weekly on Days 1, 8, 15, and 22, and then 15 mg IV weekly starting on Day 29 * HER2-amplified and Triple negative - 8 mg IV weekly on Days 1, 8, 15, and 22

Neratinibdrug

28 day treatment cycle • 240 mg orally daily