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Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer

NCT01111825 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2018-09-26

Study results available
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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.

Conditions

Interventions

DRUG

Temsirolimus

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

DRUG

Neratinib

28 day treatment cycle • 240 mg orally daily

Sponsors & Collaborators

  • Puma Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Puma Biotechnology · Puma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2016-07-31
Completion
2016-07-31
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • France
  • Hong Kong
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01111825 on ClinicalTrials.gov