Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everol
This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation). Treatment Group 2: Palazestrant (OP-1250) in combination with alpelisib (PIQRAY®, Novartis
| Condition(s) | Metastatic Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Breast Cancer, Locally Advanced Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation). Treatment Group 2: Palazestrant (OP-1250) in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation). Treatment Group 3: Palazestrant (OP-1250) in combination with everolimus. Treatment Group 4: Palazestrant (OP-1250) in combination with atirmociclib. |
| Who can participate | Inclusion Criteria: * Female or male aged \>18 years. * Willing and able to participate and comply with all study requirements. * Histologically- or cytologically-confirmed advanced or metastatic Breast Cancer (mBC). * ER+/HER2- disease, as determined in the most recently obtained archival tumor tissue sample from a metastatic site, using locally accepted criteria by the local pathology report. * Evaluable disease with one of the following: Measurable disease, ie, at least 1 measurable lesion as per RECIST 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation) OR patients with predominantly bone disease (with or without other non-measurable lesions) are allowed if it is possible to evaluate on radiol |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Olema Pharmaceuticals, Inc. |
| Locations | Gilbert, Arizona, United States; San Francisco, California, United States; Aurora, Colorado, United States; Orlando, Florida, United States; Iowa City, Iowa, United States; Boston, Massachusetts, United States (+10 more sites) |
| Start date | 2022-08-31 |
| NCT ID | NCT05508906 |
| Official listing | https://clinicaltrials.gov/study/NCT05508906 |