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Incyte suspended development of the compound.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A - INCB007839 and Trastuzumab | Experimental | INCB007839 100 mg BID and trastuzumab In Cycle 1, 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. |
|
| Treatment B - INCB007839 and Trastuzumab | Experimental | INCB007839 200 mg BID and trastuzumab In Cycle 1, 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. |
|
| Treatment C - INCB007839 and Trastuzumab | Experimental | INCB007839 300 mg BID and trastuzumab In Cycle 1, 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. |
|
| Treatment D - INCB007839 and Docetaxel | Experimental | INCB007839 300mg BID with docetaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB007839 | Drug | 100 mg BID |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (complete + partial response) using RECIST (Response Evaluation Criteria in Solid Tumor) criteria | Day 1 of each completed subsequent 21-day treatment cycle and the End of Study Visit. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bijyoyesh Mookerjee, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visakhapatnam | Andhra Pradesh | India | ||||
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| INCB007839 |
| Drug |
200 mg BID |
|
| INCB007839 | Drug | 300 mg BID |
|
| INCB007839 | Drug | 300 mg BID |
|
| trastuzumab | Drug | 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. |
|
| Docetaxel | Drug |
|
| Monthly |
| New Delhi |
| Ansari Nagar |
| India |
| Mangalore | Attavar | India |
| Bangalore | Karnataka | India |
| Hyderabaad | Punjagutta | India |
| Bangalore | Ram Nagar | India |
| Delhi | Rohini | India |
| Delhi | Vasundhara Enclave | India |
| Bhopal | India |
| Kolkata | India |
| Nashik | India |
| Pune | India |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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