Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

Olema : A Phase 1 Dose Escalation and Dose 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy | BreastBreast

Trial Overview Read MoreRead more

This Phase I trial is seeking to determine the recommended dose, safety and tolerability of a new hormone therapy (OP-1250) in combination with targeted therapy (palbociclib) in people with advanced or metastatic HR+ and HER2- breast cancer.
 

This trial is treating patients with HR+ and HER2- breast cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 1 Dose Escalation and Dose 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

Commercial Sponsor

Olema Pharmaceuticals, Inc.

Summary

This study consists of two parts: Part 1 Dose Escalation, and Part 2 Dose Expansion. In Part 1, participants will be allocated to receive different dosage levels of OP-1250 and this will be administered (orally) once daily in continuous 28-day cycles, in combination with oral palbociclib (125mg) once daily for 21 days in continuous 28-day cycles. Participants will continue to receive treatment at the assigned dose level, or at a reduced dose if required based on any toxicities that occur. Part 2 further explores the safety and Pharmacokinetics of OP-1250 in combination with Palbociclib and to determine the recommended Phase II dose (RP2D) of OP-1250.

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
Breast and Gynaecology Research Study Coordinator
breastgynae.oncresearch@monashhealth.org
0491299561

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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