This is a single arm, modified dose escalation, open label trial with the objectives of: (1) Determining a safe optimal dose of INCB007839 in combination with trastuzumab and docetaxel (2) Determining clinical efficacy and safety of INCB007839 in combination with trastuzumab and docetaxel.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Unnamed facility
Visakhapatnam, Andhra Pradesh, India
Unnamed facility
New Delhi, Ansari Nagar, India
Unnamed facility
Mangalore, Attavar, India
Unnamed facility
Bangalore, Karnataka, India
Overall response rate (complete + partial response) using RECIST (Response Evaluation Criteria in Solid Tumor) criteria
Time frame: Day 1 of each completed subsequent 21-day treatment cycle and the End of Study Visit.
To determine the plasma pharmacokinetic (PK) profile of INCB007839 and trastuzumab when given in combination
For Cycle 1, PK samples to be collected on Day 8 and Day 15 at pre-dose the morning dose of INCB007839. For Cycles 2, 3 and 4, PK will be collected as a single sample, obtained at pre-dose, on Day 1. PK samples will not be collected at Cycle 5 or later. o. For Cycle 1, PD samples to be collected at time of screening and at pre-dose on Day 1, Day
Time frame: Monthly
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300 mg BID
trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1.
Unnamed facility
Hyderabaad, Punjagutta, India
Unnamed facility
Bangalore, Ram Nagar, India
Unnamed facility
Delhi, Rohini, India
Unnamed facility
Delhi, Vasundhara Enclave, India
Unnamed facility
Bhopal, India
Unnamed facility
Kolkata, India
...and 2 more locations