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PI3K Inhibitor
Combo Therapy for Breast Cancer
Phase 1
Recruiting
Research Sponsored by Olema Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to see if they are safe and effective in treating patients with hormone receptor positive, human epidermal growth factor receptor 2 negative advanced or metastatic breast cancer.
Who is the study for?
This trial is for adults over 18 with advanced or metastatic HR+/HER2- breast cancer, who've had no more than one prior chemo and up to two hormone therapies. They should have a life expectancy of at least 6 months and be able to follow the study plan. Exclusions include other cancers, heart disease, liver disease not in early stages, recent serious blood clots or stroke, lung conditions like pneumonitis, or HIV.Check my eligibility
What is being tested?
The study tests OP-1250 combined with either ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2). It's an open-label Phase 1b trial meaning both researchers and participants know which treatment is given. The goal is to assess safety and effectiveness of these combinations in treating breast cancer.See study design
What are the potential side effects?
Potential side effects may include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Liver function issues could occur due to oral medication absorption. Heart rhythm abnormalities are also possible along with general discomfort from taking the medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Characterize the incidence, nature and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2)
Dose Limiting Toxicities (DLTs)
Pharmacokinetics (PK) of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2)
Secondary outcome measures
Evaluate clinical benefit rate (CBR) of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2)
Evaluate duration of response (DOR) of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2)
Preliminarily assess the anti-tumor activity of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2)
Trial Design
2Treatment groups
Experimental Treatment
Group I: OP-1250 with RibociclibExperimental Treatment2 Interventions
Treatment Group 1: OP-1250 in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).
Group II: OP-1250 with AlpelisibExperimental Treatment2 Interventions
Treatment Group 2: OP-1250 in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alpelisib
2018
Completed Phase 3
~900
Ribociclib
2018
Completed Phase 3
~2330
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Who is running the clinical trial?
Olema Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
693 Total Patients Enrolled
2 Trials studying Breast Cancer
540 Patients Enrolled for Breast Cancer
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,720,945 Total Patients Enrolled
57 Trials studying Breast Cancer
21,188 Patients Enrolled for Breast Cancer
Mark Shilkrut, M.D.Study DirectorOlema Pharmaceuticals, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pneumonitis or lung disease affecting the tissue and space around the air sacs.I am fully active or can carry out light work.My breast cancer is HR+ and HER2- as confirmed by tests.I am HIV positive.I have been on hormone therapy for breast cancer for at least 6 months.I haven't had a stroke or brain blood vessel issue in the last 6 months.I am over 18 years old.I have no stomach or intestine problems affecting medication absorption.I do not have uncontrolled heart disease or abnormal heart rhythms.I have had only one chemotherapy for advanced breast cancer.I have had 2 or fewer hormone treatments for my advanced cancer.I have had only one prior hormone therapy.I have had a blood clot in my lungs or veins in the past 6 months, or I'm at high risk for clots.I don't have another cancer that could affect this treatment's safety or results.I have cancer that has spread to the lining of my brain or spinal cord, or I have pressure on my spinal cord.I have a significant liver condition, such as hepatitis or cirrhosis.
Research Study Groups:
This trial has the following groups:- Group 1: OP-1250 with Ribociclib
- Group 2: OP-1250 with Alpelisib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the OP-1250 and Ribociclib combination been cleared by governmental regulations?
"Due to the trial's status as a Phase 1, our team at Power estimated OP-1250 combined with Ribociclib's safety rating on a scale of one to three as one. This is because there is comparatively sparse data available confirming efficacy and its safety profile."
Answered by AI
Are there opportunities to join this research endeavor at the present time?
"Affirmative. Clinicaltrials.gov indicates that this investigation, which commenced on August 31st 2022, is still actively recruiting patients for the trial. 60 participants are needed at a solitary site."
Answered by AI
How extensive is the participation in this clinical trial?
"Indeed, the listing on clinicaltrials.gov details that this medical trial is actively enrolling participants. It was initially posted in August 31st 2022 and has most recently been updated September 22nd 2022. With 60 patients being accepted at a single site, recruitment is currently underway."
Answered by AI
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