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

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ClinicalTrials.gov Identifier: NCT01254136
Recruitment Status : Terminated (Incyte has suspended development of the compound.)
First Posted : December 6, 2010
Last Update Posted : January 25, 2012
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: INCB007839 300mg BID Drug: Trastuzumab Drug: Vinorelbine Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study to Assess the Safety and Therapeutic Effect of INCB007839 in Combination With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer.
Study Start Date : October 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Overall objective response rate assessed by RECIST criteria [ Time Frame: Measured at Baseline, Cycle 4 and approximately every 9 weeks after (estimated duration 6-9 months) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer
  • 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 Left ventricular ejection fraction (LVEF) below institutional normal range
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254136


Locations
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United States, Arkansas
Fayetteville, Arkansas, United States
United States, California
Duarte, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Florida
Davie, Florida, United States
Jacksonville, Florida, United States
United States, Michigan
Detroit, Michigan, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New Jersey
Hackensack, New Jersey, United States
United States, New York
Lake Success, New York, United States
United States, North Carolina
Huntersville, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Utah
Salt Lake, Utah, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
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Principal Investigator: Denise A. Yardley, MD Sara Cannon Research Institute
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01254136    
Other Study ID Numbers: INCB 7839-204
First Posted: December 6, 2010    Key Record Dates
Last Update Posted: January 25, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Vinorelbine
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action