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Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer

NCT01254136 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-01-25

No results posted yet for this study

Summary

This Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839 in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast cancer.

Conditions

Interventions

DRUG

INCB007839 300mg BID

INCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met.

DRUG

Trastuzumab

INCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met.

DRUG

Vinorelbine

INCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met.

Sponsors & Collaborators

Principal Investigators

  • Denise A. Yardley, MD · Sara Cannon Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-09-30
Completion
2011-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT01254136 on ClinicalTrials.gov