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

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Incyte Corporation
Study ID
NCT01254136
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INCB007839 300mg BID — DRUG
    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.
  • Trastuzumab — DRUG
    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.
  • Vinorelbine — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 31, 2010
Status verified
Jan 2012
Primary completion
Sep 30, 2011
Completion
Oct 31, 2011

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment A - INCB007839 300mg BID
    This is a single arm, open label study in which all patients will receive a single dose of the investigational product INCB007839 in combination with a standard regimen of trastuzumab and vinorelbine.

Primary Outcome Measure

Evaluation of safety and tolerabilty as determined by monitoring the frequency and severity of adverse events (AEs) and performing clinical assessments and laboratory investigations. [ Time Frame: Measured monthly starting at Baseline (estimated duration 6-9 months) ]

Locations (14)

FacilityCityStateZIPSite coordinators
-FayettevilleArkansas--
-DuarteCalifornia--
-DenverColorado--
-DavieFlorida--
-JacksonvilleFlorida--
-DetroitMichigan--
-St LouisMissouri--
-HackensackNew Jersey--
-Lake SuccessNew York--
-HuntersvilleNorth Carolina--
-CincinnatiOhio--
-PhiladelphiaPennsylvania--
-NashvilleTennessee--
-Salt Lake CityUtah--

Find similar trials in Fayetteville, AR

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health

Related Studies