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Hormone Therapy

OP-1250 for Breast Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Olema Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have received at least 1 prior hormonal regimen and at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic disease

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 42 days after end of treatment

Awards & highlights

Study Summary

This trial is testing a new drug, OP-1250, to see if it is safe and effective against tumors.

Who is the study for?

This trial is for adults with advanced HR-positive, HER2-negative breast cancer who've had at least one hormonal treatment and six months of continuous endocrine therapy. Participants need good liver and kidney function, haven't had certain therapies recently, are not pregnant or breastfeeding, willing to use contraception, have a stable ECOG status (0 or 1), and no significant heart disease or infections.Check my eligibility

What is being tested?

The study is testing different doses of OP-1250 to find the safest and most effective level for treating hormone receptor-positive, HER2-negative advanced breast cancer. It's an open-label trial meaning everyone knows what treatment they're getting.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones in trials like this may include nausea, fatigue, headache, hot flashes related to hormonal changes; plus potential liver or kidney-related issues due to medication processing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had hormone therapy for my advanced cancer for at least 6 months.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 42 days after end of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 42 days after end of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 days after end of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anti-tumor activity of OP-1250

Characterize the incidence, nature and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of OP-1250

Dose Limiting Toxicities (DLT)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: OP-1250 Phase IIExperimental Treatment1 Intervention

This portion of the study further explores the clinical activity, safety, and PK of OP-1250 monotherapy at the RP2D and will estimate preliminary anti-tumor efficacy in 3 cohorts. Cohort A will enroll subjects with measurable disease without evidence of CNS metastases; Cohort B will enroll subjects with non-measurable (evaluable) disease without evidence of CNS metastases; and Cohort C will enroll subjects with evaluable disease (measurable and non-measurable) with CNS metastases.

Group II: OP-1250 Phase I Part A (Dose Escalation) and Part B (Dose Expansion)Experimental Treatment1 Intervention

Phase I Part A will evaluate the safety and pharmacokinetics (PK)of a range of OP-1250 doses to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Phase I Part B will evaluate the safety and PK of OP-1250 to confirm the RP2D dose.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Olema Pharmaceuticals, Inc.Lead Sponsor

3 Previous Clinical Trials

630 Total Patients Enrolled

2 Trials studying Breast Cancer

540 Patients Enrolled for Breast Cancer

Jo Anne Zujewski, MDStudy DirectorOlema Pharmaceuticals, Inc.

Trinh LeStudy DirectorOlema Pharmaceuticals, Inc.

1 Previous Clinical Trials

11 Total Patients Enrolled

Media Library

OP-1250 (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04505826 — Phase 1 & 2

Breast Cancer Research Study Groups: OP-1250 Phase II, OP-1250 Phase I Part A (Dose Escalation) and Part B (Dose Expansion)

Breast Cancer Clinical Trial 2023: OP-1250 Highlights & Side Effects. Trial Name: NCT04505826 — Phase 1 & 2

OP-1250 (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04505826 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different areas is this trial accessible?

"There are 4 sites running this trial at the moment, located in Sarasota, Orlando, Nashville and other locations. If you wish to participate it would be best to select a location nearest to you so as to not incur extensive travel costs."

Answered by AI

Are recruitment efforts for this trial still underway?

"That is correct. The clinical trial, which began recruiting on August 13th 2020, is currently looking for 94 patients at 4 different hospitals or medical centres."

Answered by AI

How many participants are currently enrolled in this trial?

"The sponsor, Olema Pharmaceuticals, Inc., needs 94 eligible patients to proceed with the trial. The research will be conducted in Advent Health (Orlando, Tennessee) and Florida Cancer Center (Sarasota, Florida)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer

2020. "A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04505826.

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