Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer
NCT ID: NCT01254136
Last Updated: 2012-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2010-10-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Subject with histological HER2+ status as determined by FISH with a gene amplification score of ≥ 2.2
* Subject with availability of archival biopsy tissue from primary tumor or metastatic lesions
* Subject with presence of measurable disease based on RECIST 1.1
* Subject who has received no more than three prior HER2-directed therapeutic regimens for advanced breast cancer
Exclusion Criteria
* Subject with metastasis to the central nervous system UNLESS asymptomatic and clinically stable
* Subject with current active malignancy other than breast cancer
* Subject with prior history of other malignancy except for cancers from which the patient is currently disease free
* Subject with significant renal or hepatic dysfunction
* Subject with history of venous or arterial thrombosis or risk factor for thrombosis other than history of malignancy
* Subject with insufficient bone marrow function
* Subject with contraindication to vinorelbine, trastuzumab, aspirin and/or warfarin therapy.
* Subject with current active bacterial, Hepatitis B or C, and/or HIV infections
18 Years
FEMALE
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Denise A. Yardley, MD
Role: PRINCIPAL_INVESTIGATOR
Sara Cannon Research Institute
Locations
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Fayetteville, Arkansas, United States
Duarte, California, United States
Denver, Colorado, United States
Davie, Florida, United States
Jacksonville, Florida, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
Hackensack, New Jersey, United States
Lake Success, New York, United States
Huntersville, North Carolina, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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INCB 7839-204
Identifier Type: -
Identifier Source: org_study_id
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