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A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05266105
Recruitment Status : Recruiting
First Posted : March 4, 2022
Last Update Posted : March 4, 2022
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Olema Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE February 11, 2022
First Posted Date  ICMJE March 4, 2022
Last Update Posted Date March 4, 2022
Actual Study Start Date  ICMJE December 10, 2021
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2022)
  • Incidence of Dose Limiting Toxicities [ Time Frame: From Cycle 1 Day 1 through C1 Day 28 ]
  • Characterization and Incidence in Adverse Events and Serious Adverse Events [ Time Frame: From initial inform consent date through 30 days post last dose ]
  • Plasma levels of OP-1250 and Palbociclib [ Time Frame: Up to 9 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
Official Title  ICMJE A Phase 1 Dose Escalation and Expansion Open-label, Multicenter, Study of OP-1250 in Combination With the CDK4/6 Inhibitor Palbociclib in Adult Subjects With Advanced or Metastatic HR-positive, HER2-negative Breast Cancer
Brief Summary This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.). Purpose of study is to evaluate the safety and pharmacokinetic (PK) profile, and estimate the preliminary anti-tumor activity of the combination in adult subjects with hormone receptor-positive (ER+ / HER2-) advanced or metastatic breast cancer (MBC).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: OP-1250
    Complete Estrogen Receptor Antagonist
  • Drug: Palbociclib
    Palbociclib is an approved CDK 4/6 Inhibitor drug
    Other Name: Ibrance®️
Study Arms  ICMJE
  • Experimental: Dose Escalation
    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
    Interventions:
    • Drug: OP-1250
    • Drug: Palbociclib
  • Experimental: Dose Expansion
    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
    Interventions:
    • Drug: OP-1250
    • Drug: Palbociclib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 23, 2022)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed and evaluable locally advanced or metastatic breast cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Must not have received prior oral endocrine or targeted therapy ≤ 2 weeks prior to first dose
  • Must not have received prior chemotherapy, antibody therapy, or investigational therapy ≤ 4 weeks prior to the first dose
  • Prior radiotherapy must have been completed 2 weeks prior to first dose
  • Adequate safety laboratory tests
  • Willingness to use effective contraception

Exclusion Criteria:

  • Gastrointestinal disease
  • Significant hepatic disease
  • Significant cardiovascular disease
  • Significant ECG abnormalities
  • History of pulmonary embolism or high risk of thrombosis
  • Known HIV infection
  • Active infection (requiring antimicrobial therapy)
  • Pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: General Contact Info 415-651-7206 clinical@olema.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05266105
Other Study ID Numbers  ICMJE OP-1250-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Olema Pharmaceuticals, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Olema Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Sue Johnson Olema Pharmaceuticals, Inc.
PRS Account Olema Pharmaceuticals, Inc.
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP