Spots Global Cancer Trial Database for Phase 1b Combo w/ Ribociclib and Alpelisib
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Trial Identification
Brief Title: Phase 1b Combo w/ Ribociclib and Alpelisib
Official Title: A Phase 1b Open-Label Multicenter Study of OP-1250 in Combination With the CDK4/6 Inhibitor Ribociclib or With the PI3K Inhibitor Alpelisib in Adult Subjects With Advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer
Study ID: NCT05508906
Study Description
Brief Summary: This is a Phase 1b open-label, 2-part study in 2 treatment groups. The 2 treatment groups are as follows: Treatment Group 1: OP-1250 in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation). Treatment Group 2: OP-1250 in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation).
Detailed Description: Part 1 (Dose Escalation): This part will evaluate the safety and pharmacokinetics (PK) of a range of doses of OP-1250 administered orally (PO) every day (QD) to subjects in combination with either 600 mg of ribociclib administered PO QD (Treatment Group 1) or with 300 mg of alpelisib administered PO QD (Treatment Group 2) to determine the recommended phase 2 dose (RP2D). The dose escalation phase will evaluate 3 to 6 subjects per cohort who are sequentially enrolled and monitored for DLTs during the first cycle of study treatment. Each cohort will be reviewed for safety, PK, and dose-limiting toxicity DLTs. The DLT observation may be extended to 2 cycles. Part 2 (Dose Expansion): This part of the study will further evaluate the safety and PK of OP-1250 at the RP2D in combination with either ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2) and provide an exploratory estimate of anti-tumor activity of the combinations.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
University of California San Francisco Health, San Francisco, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Advent Health Hematology and Oncology, Orlando, Florida, United States
University of Iowa, Iowa City, Iowa, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Health, Detroit, Michigan, United States
Regents of the University of Minnesota, Minneapolis, Minnesota, United States
Washington University, School of Medicine, Saint Louis, Missouri, United States
Ichan School of Medicine at Mount Sinai, New York, New York, United States
Atrium Health Levine Cancer Institute, Charlotte, North Carolina, United States
Henry-Joyce Cancer Clinic, The Vanderbilt Clinic, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Northwest Medical Specialties, Tacoma, Washington, United States
Breast Cancer Research Center- Western Australia, Nedlands, Western Australia, Australia
Macquarie Health, New South Wales, , Australia
Contact Details
Name: Mark Shilkrut, M.D.
Affiliation: Olema Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
Name: Eric Park, M.D.
Affiliation: Olema Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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