Breast Cancer
Conditions
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.
Interventions
DRUGINCB007839 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.
DRUGTrastuzumab
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.
DRUGVinorelbine
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.
Sponsors
Incyte Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of safety and tolerabilty as determined by monitoring the frequency and severity of adverse events (AEs) and performing clinical assessments and laboratory investigations. | Measured monthly starting at Baseline (estimated duration 6-9 months) |
Secondary
| Measure | Time frame |
|---|---|
| Overall objective response rate assessed by RECIST criteria | Measured at Baseline, Cycle 4 and approximately every 9 weeks after (estimated duration 6-9 months) |
Countries
United States
Outcome results
None listed