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Incyte has suspended development of the compound.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A - INCB007839 300mg BID | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB007839 300mg BID | Drug | 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. |
| Measure | Description | 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) |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise A. Yardley, MD | Sara Cannon Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayetteville | Arkansas | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38182653 | Derived | Park EJ, Lee CW. Soluble receptors in cancer: mechanisms, clinical significance, and therapeutic strategies. Exp Mol Med. 2024 Feb;56(1):100-109. doi: 10.1038/s12276-023-01150-6. Epub 2024 Jan 5. |
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|
| Trastuzumab | Drug | 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. |
|
| Vinorelbine | Drug | 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. |
|
| Duarte |
| California |
| United States |
| Denver | Colorado | United States |
| Davie | Florida | United States |
| Jacksonville | Florida | United States |
| Detroit | Michigan | United States |
| St Louis | Missouri | United States |
| Hackensack | New Jersey | United States |
| Lake Success | New York | United States |
| Huntersville | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Philadelphia | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Salt Lake City | Utah | United States |
| 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 |
|---|---|
| C494814 | BID protein, human |
| D000068878 | Trastuzumab |
| D000077235 | Vinorelbine |
| 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 |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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