palazestrant (OP-1250) / Olema Pharma 
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  • ||||||||||  palazestrant (OP-1250) / Olema Pharma
    Enrollment change, Trial completion date, Trial primary completion date:  OP-1250-003: Phase 1b Combo w/ Ribociclib, Alpelisib, or Everolimus (clinicaltrials.gov) -  Oct 2, 2024   
    P1,  N=155, Recruiting, 
    Recruiting --> Active, not recruiting N=90 --> 155 | Trial completion date: Aug 2024 --> Jun 2026 | Trial primary completion date: Aug 2024 --> May 2026
  • ||||||||||  palazestrant (OP-1250) / Olema Pharma
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  OP-1250-002: A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients (clinicaltrials.gov) -  Jun 6, 2024   
    P1,  N=60, Active, not recruiting, 
    All other abstracts will be released on the day of presentation. Recruiting --> Active, not recruiting | N=30 --> 60 | Trial completion date: Dec 2023 --> Jul 2025 | Trial primary completion date: Jan 2023 --> Jan 2025
  • ||||||||||  palazestrant (OP-1250) / Olema Pharma
    Phase classification, Enrollment change:  OP-1250-003: Phase 1b Combo w/ Ribociclib, Alpelisib, or Everolimus (clinicaltrials.gov) -  Jan 11, 2024   
    P1,  N=90, Recruiting, 
    Antitumor activity and clinical benefit, including in heavily pretreated patients, were observed. Phase classification: P1b --> P1 | N=60 --> 90
  • ||||||||||  palazestrant (OP-1250) / Olema Pharma
    Enrollment open, Monotherapy:  OPERA-01: OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer (clinicaltrials.gov) -  Nov 13, 2023   
    P3,  N=510, Recruiting, 
    With demonstrated preclinical efficacy exceeding fulvestrant in wild-type models, elacestrant in ESR1-mutant models, and tamoxifen in intracranial xenografts, OP-1250 has the potential to benefit patients with ER+ breast cancer. Not yet recruiting --> Recruiting
  • ||||||||||  palazestrant (OP-1250) / Olema Pharma
    Enrollment open:  OP-1250-003: Phase 1b Combo w/ Ribociclib, Alpelisib, or Everolimus (clinicaltrials.gov) -  Sep 26, 2022   
    P1b,  N=60, Recruiting, 
    OP-1250 is currently being evaluated in a Phase Ib clinical trial in combination with palbociclib and a study including evaluation of the combination of OP-1250 with ribociclib is planned to initiate in Q3 2022. Not yet recruiting --> Recruiting
  • ||||||||||  OP-1250 / Olema Pharma
    OP-1250 prevents tumor spread in a model of metastatic mutant ERα+ breast cancer (Section 11) -  Mar 9, 2022 - Abstract #AACR2022AACR_4376;    
    Mice were treated with 3 and 10 mg/kg of OP-1250 alone or in combination with palbociclib at 70mg/kg and tumor growth was monitored via a Xenogen IVIS imager...OP-1250 at both doses inhibited primary tumor growth as well as metastasis to the lung, liver, brain and bone, with greater effect at 10 mg/kg, and was significantly more effective than Faslodex...Our results also suggest that the efficacy seen in the combination study was driven primarily by OP-1250. In total, these results demonstrate the potential use of OP-1250, both alone and in combination with a CDK4/6 inhibitor, to inhibit tumor growth and metastasis in a model of aggressive mutant ER+ MBC.