Olaparib + Sapacitabine for Breast Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Filipa Lynce, MD - Dana-Farber Cancer ...

Sara M. Tolaney, MD, MPH - Dana-Farber ...

Overseen ByFilipa Lynce, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?This research study is studying a combination of drugs as a possible treatment for breast cancer with a BRCA mutation. The interventions involved in this study are: * Sapacitabine (CYC682) * Olaparib (Lynparza™)

Eligibility Criteria

This trial is for adults with metastatic or unresectable breast cancer that has a BRCA mutation. Candidates must have progressed after certain therapies, depending on their cancer type. They should be able to take oral medication and agree to use effective contraception. People with recent treatments, active hepatitis or HIV, heart issues, prior PARP inhibitor treatment, MDS/AML history, major surgery complications within 2 weeks before the study start are excluded.

Inclusion Criteria

My cancer can be measured or seen on tests.

My HER2-positive cancer has worsened after two different HER2 treatments.

My breast cancer is confirmed and cannot be removed by surgery.

I can swallow and keep down pills.

I agree to use two effective birth control methods during the study and for 6 months after.

My cancer is hormone receptor-positive and has worsened despite hormone therapy.

I am 18 years old or older.

I am a woman who is either postmenopausal or not currently pregnant.

I am fully active or can carry out light work.

I am willing and able to follow the study's treatment and visit schedule.

I have a harmful BRCA1 or BRCA2 gene mutation.

Exclusion Criteria

I have had more than 3 chemotherapy treatments for my cancer after it spread.

I do not have any uncontrolled illnesses.

I am not taking strong or moderate CYP3A inhibitors.

I have never been treated with sapacitabine.

I cannot swallow pills or have a stomach condition that affects medication absorption.

I am allergic to medications similar to sapacitabine or olaparib.

I have a history of or signs pointing to blood disorders like MDS or AML.

I or someone in my family has long QT syndrome.

I currently have inflammation in my lungs.

I have had a bone marrow or cord blood transplant in the past.

I have active Hepatitis B, C, or am HIV positive.

I have never been treated with a PARP inhibitor like olaparib.

Participant Groups

The study tests a combination of two drugs: Sapacitabine (CYC682) and Olaparib (Lynparza™), as potential treatments for breast cancer with BRCA mutations. It's structured in phases; phase I evaluates safety while phase II measures how well the disease responds according to RECIST criteria.

4Treatment groups

Experimental Treatment

Group I: Dose Level 3: Sapacitabine (250 mg) + Olaparib (300 mg)Experimental Treatment2 Interventions

* Olaparib will be administered orally twice daily for each 28-day cycle * Sapacitabine will be administered orally once daily on days 1 - 5 and 8 - 12 of every 28-day cycle

Group II: Dose Level 2: Sapacitabine (200 mg) + Olaparib (300 mg)Experimental Treatment2 Interventions

* Olaparib will be administered orally twice daily for each 28-day cycle * Sapacitabine will be administered orally once daily on days 1 - 5 and 8 - 12 of every 28-day cycle

Group III: Dose Level 1: Sapacitabine (150 mg) + Olaparib (300 mg)Experimental Treatment2 Interventions

* Olaparib will be administered orally twice daily for each 28-day cycle * Sapacitabine will be administered orally once daily on days 1 - 5 and 8 - 12 of every 28-day cycle

Group IV: Dose Level -1: Sapacitabine (100 mg) + Olaparib (300 mg)Experimental Treatment2 Interventions

* Olaparib will be administered orally twice daily for each 28-day cycle * Sapacitabine will be administered orally once daily on days 1 - 5 and 8 - 12 of every 28-day cycle

Olaparib is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Lynparza for: