Adavosertib + Olaparib for Recurrent Ovarian Cancer

Palo Alto (17 mi)

Overseen byShannon Westin

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies how well adavosertib with or without olaparib work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent). Adavosertib and olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

This trial is for adults with recurrent ovarian, primary peritoneal, or fallopian tube cancer who've seen their disease progress on PARP inhibitors. They should have a measurable lesion and be in relatively good health (ECOG score 0-1). Women must not be pregnant, breastfeeding, and agree to use contraception. People can't join if they have heart issues like long QT syndrome, uncontrolled brain metastases, severe reactions to study drugs or certain drug interactions.

Inclusion Criteria

My ovarian, peritoneal, or fallopian tube cancer has returned and cannot be cured with available treatments.

My cancer is BRCA mutant or HRD positive.

I am 18 years old or older.

I have saved tissue samples from before my PARP inhibitor treatment.

My cancer progressed despite being on a PARP inhibitor treatment.

I have seen improvement with PARP inhibitor treatment for at least 6 months.

My organs and bone marrow are functioning well.

Exclusion Criteria

I have not had a blood transfusion in the last 4 months.

I do not have a serious infection or condition that would stop me from receiving the study treatment.

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

I have not had serious heart problems in the last 6 months.

My heart's electrical activity (QTc interval) is normal.

I have had a bone marrow or double umbilical cord blood transplant.

I have heart conditions or family history that could affect my heart's rhythm.

I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

I am not taking any strong or moderate drugs that affect liver enzymes.

I have high blood pressure that needs treatment.

I have been diagnosed with ataxia telangiectasia.

I have experienced side effects from previous treatments, but not hair loss or loss of appetite.

I am not taking strong or moderate drugs that affect liver enzymes.

Treatment Details

The trial tests adavosertib alone or combined with olaparib in patients whose cancer has returned. These drugs may block enzymes that tumor cells need to grow. Participants are chosen for different treatment groups based on specific criteria and will receive the treatments to see which works better.

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm III (ceralasertib, olaparib)Experimental Treatment2 Interventions

Patient receive ceralasertib tablets by PO BID each day on Days 1-14. You will also take olaparib tablets by PO BID each day on Days 1-28.

Group II: Arm II (olaparib, adavosertib)Experimental Treatment2 Interventions

Patients receive olaparib PO BID on days 1-21 and adavosertib PO QD on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group III: Arm I (adavosertib)Active Control1 Intervention

Patients receive adavosertib PO QD on days 1-5 and 8-12. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.