OP-1250 with Ribociclib for Metastatic Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Advent Health Hematology and Oncology, Orlando, FLMetastatic Breast Cancer+3 MoreOP-1250 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Metastatic Breast Cancer
  • Breast Cancer
  • Hormone Receptor-positive Breast Cancer
  • HER2-negative Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Ribociclib
1
Talazoparib
1
ribociclib

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: Completion of Dose Expansion up to 1 year

Day 28
Identify DLT, MTD, and RP2D of OP-1250
Year 1
Assess the anti-tumor activity using RECIST
Assess the safety and tolerability
Measure
Measure

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Ribociclib
1
Talazoparib
1
ribociclib

Trial Design

2 Treatment Groups

OP-1250 with Ribociclib
1 of 2
OP-1250 with Alpelisib
1 of 2

Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: OP-1250 with Ribociclib · No Placebo Group · Phase 1

OP-1250 with RibociclibExperimental Group · 2 Interventions: OP-1250, Ribociclib · Intervention Types: Drug, Drug
OP-1250 with AlpelisibExperimental Group · 2 Interventions: OP-1250, Alpelisib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
2018
Completed Phase 3
~9090
Alpelisib
2015
Completed Phase 1
~30

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: completion of dose expansion up to 1 year

Who is running the clinical trial?

Olema Pharmaceuticals, Inc.Lead Sponsor
2 Previous Clinical Trials
124 Total Patients Enrolled
NovartisIndustry Sponsor
1,588 Previous Clinical Trials
2,703,912 Total Patients Enrolled
15 Trials studying Metastatic Breast Cancer
8,715 Patients Enrolled for Metastatic Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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