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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.


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

Measured monthly starting at Baseline (estimated duration 6-9 months)

Safety Issue:

Yes

Principal Investigator

Denise A. Yardley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sara Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

INCB 7839-204

NCT ID:

NCT01254136

Start Date:

October 2010

Completion Date:

October 2011

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Flint, Michigan  48532
Little Rock, Arkansas  72205-7199
Hackensack, New Jersey  07601
Denver, Colorado  
Charlotte, North Carolina  
Salt Lake City, Utah  84112