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Adjusted LOA
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Palazestrant · 4 trials · 8 indications
To compare PFS, based on a local investigator assessment, between investigational (palazestrant with ribociclib + letrozole-matching placebo) and control (letrozole with ribociclib + palazestrant-matching placebo) arms.
To evaluate the number of participants with adverse events
To evaluate the number of participants reducing the dose of palazestrant
To evaluate the number of participants discontinuing palazestrant
To compare PFS, based on a Blinded Independent Review Committee (BIRC) assessment, between arms of OP-1250 and standard-of-care treatment. This will be assessed separately in populations of ESR1-mutation detected and ESR1-mutation not detected participants.
To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and/ or recommended dose expansion (RDE) of palazestrant when administered with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), or everolimus (Treatment Group 3), or atirmociclib (Treatment Group 4). The incidence of DLTs will be assessed in the Dose Escalation part (Part 1) of the study.
Characterize the incidence, nature and severity of TEAEs and SAEs of palazestrant when administered with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), everolimus (Treatment Group 3), or atirmociclib (Treatment Group 4) according to NCI-CTCAE version 5.0.
To assess the PK of palazestrant (and potential metabolites) in combination with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), everolimus (Treatment Group 3), or atirmociclib (Treatment Group 4). Plasma levels of palazestrant will be assessed at predefined intervals to establish PK parameters (including: Cmax, Cmin, Tmax, AUC, and t1⁄2 as data permit) and palazestrant trough concentration at steady state).
| Arm | Type | Description |
|---|---|---|
| Palazestrant | EXPERIMENTAL | Participants will receive palazestrant, ribociclib and letrozole-matching placebo |
| Letrozole | ACTIVE_COMPARATOR | Participants will receive letrozole, ribociclib and palazestrant-matching placebo |
| Palazestrant (OP-1250) | EXPERIMENTAL | Participants will receive Palazestrant |
| Standard of Care Endocrine Therapy | ACTIVE_COMPARATOR | Participants will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane) |
| Palazestrant with Ribociclib | EXPERIMENTAL | Treatment Group 1: Palazestrant in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation). |
| Palazestrant with Alpelisib | EXPERIMENTAL | Treatment Group 2: Palazestrant in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation) |
| Palazestrant with Everolimus | EXPERIMENTAL | Treatment Group 3: Palazestrant in combination with everolimus |
| Palazestrant with Atirmociclib | EXPERIMENTAL | Treatment Group 4: Palazestrant in combination with atirmociclib |
| Dose Escalation | EXPERIMENTAL | This portion of the study will evaluate the safety and pharmacology of a range of OP-1250 doses administered daily with Palbociclib in subjects with advanced and/or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer |
| Dose Expansion | EXPERIMENTAL | This portion of the study further explores the clinical activity, safety and pharmacology of OP-1250 in combination with Palbociclib and estimates preliminary data of anti-tumor efficacy |
| Name | Type | Description |
|---|---|---|
| Palazestrant | DRUG | Participants will be treated with palazestrant 90 mg once daily on a 4-week (28-day) cycle. |
| Letrozole-matching placebo | DRUG | Participants will be treated with letrozole-matching placebo once daily on a 4-week (28 day) cycle |
| Ribociclib | DRUG | Participants will be treated with ribociclib 600 mg once daily on Days 1-21 of a 4-week (28 day) cycle. |
| Letrozole | DRUG | Participants will be treated with letrozole 2.5 mg once daily on a 4-week (28-day) cycle |
| Palazestrant matching-placebo | DRUG | Participants will be treated with palazestrant-matching placebo once daily on a 4-week (28-day) cycle |
| Fulvestrant | DRUG | Participants will be treated with fulvestrant on C1D1, C1D15, and then on Day 1 of every subsequent 4 week (28 day) cycle |
| Anastrozole | DRUG | Participants will be treated with anastrozole once daily on a 4 week (28 day) cycle |
| Exemestane | DRUG | Participants will be treated with exemestane once daily on a 4 week (28 day) cycle |
| Alpelisib | DRUG | All subjects in Treatment Group 2 will receive palazestrant in combination with alpelisib. |
| Everolimus | DRUG | All subjects in Treatment Group 3 will receive palazestrant in combination with everolimus. |
| Atirmociclib | DRUG | All subjects in Treatment Group 4 will receive palazestrant in combination with atirmociclib. |
| Palbociclib | DRUG | Palbociclib is an approved CDK 4/6 Inhibitor drug |
Inclusion Criteria: * Adult female or male participants. * ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy. * Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease). * De novo advanced breast cancer or with disease recurrence occu...
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Palazestrant is an investigational small molecule being developed for the treatment of breast cancer, including metastatic breast cancer. It is specifically studied in patients with ER-positive, HER2-negative breast cancer, both in advanced and locally advanced settings. The drug is currently in Phase 3 clinical trials.
Palazestrant is a selective estrogen receptor degrader (SERD), meaning it targets the estrogen receptor. By degrading the receptor, it aims to block estrogen signaling that drives cancer growth in ER-positive breast cancers. This mechanism is being evaluated in combination with other agents in clinical trials.
Palazestrant is being developed by Olema Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol OLMA. The company is conducting multiple clinical trials to evaluate the drug's safety and efficacy in breast cancer.
Palazestrant is in Phase 3 clinical development. It is being studied in a Phase 3 trial comparing it to standard of care for advanced breast cancer, and in another Phase 3 trial in combination with ribociclib for first-line treatment. It is also in Phase 1 trials for combination therapies.
Palazestrant is being evaluated in several trials, including NCT06016738, a Phase 3 study versus standard of care in ER+/HER2- advanced breast cancer, and NCT07085767, a Phase 3 trial with ribociclib as first-line treatment. Phase 1 trials include NCT05266105 and NCT05508906, testing combinations with other agents.
Yes, Palazestrant is also known as OP-1250. Clinical trial titles and descriptions refer to the drug as OP-1250 (Palazestrant), confirming that both names refer to the same investigational compound being developed by Olema Pharmaceuticals.