Clinical trial NCT01254136: Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
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.
timeFrame: Measured monthly starting at Baseline (estimated duration 6-9 months)
Secondary outcomes:
measure: Overall objective response rate assessed by RECIST criteria
timeFrame: Measured at Baseline, Cycle 4 and approximately every 9 weeks after (estimated duration 6-9 months)
Other outcomes:
Locations:
city: Fayetteville
country: United States
state: Arkansas
city: Duarte
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Davie
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Detroit
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Hackensack
country: United States
state: New Jersey
city: Lake Success
country: United States
state: New York
city: Huntersville
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Salt Lake
country: United States
state: Utah
Study officials:
affiliation: Sara Cannon Research Institute
name: Denise A. Yardley, MD
role: PRINCIPAL_INVESTIGATOR
References: