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A treatment protocol that enables patients to have continued access to IPI-926.
The extension protocol is a continuation of treatment with IPI-926, as administered to each individual patient during participation in their original IPI-926 protocol.
Patients who are completing their participation in the original IPI-926 protocol in which they enrolled, as defined in the original protocol, and, have stable disease or confirmed complete or partial response as defined by the original protocol may continue to receive treatment with IPI-926 in the extension protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPI-926 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPI-926 | Drug | IPI-926 is administered orally as a capsule formulation, as a fixed dose in mg/day. Patients will be administered the same dose with same cycle length of IPI-926 and combination therapy that they were receiving in the original protocol at the time of transition into the extension study. The following are potential once-daily doses that patients are receiving in original protocols: 60 mg, 90 mg, 100 mg, 110 mg, 130 mg, or 160 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs), and laboratory test results | Monitoring of AEs, including SAEs as well as review of laboratory sample test data to assess safety and tolerability of IPI-926 | Up to 30 days after the last patient study visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tess Schmalbach, MD | Infinity Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States | ||
| Johns Hopkins |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| D002813 | Chondrosarcoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C541444 | IPI-926 |
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|
|
| Baltimore |
| Maryland |
| 21205 |
| United States |
| D018295 |
| Neoplasms, Basal Cell |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |