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

Incyte

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Breast Cancer

Treatments: Drug: Trastuzumab; Drug: INCB007839 300mg BID; Drug: Vinorelbine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01254136

INCB 7839-204

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Treatment A - INCB007839 300mg BID

Experimental group

Description:

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.

Treatment:

Drug: Trastuzumab

Drug: Vinorelbine

Drug: INCB007839 300mg BID