Pre-Surgery Olaparib for Ovarian Cancer (NEO Trial)

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen ByAmit Oza, MD

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University Health Network, Toronto

Stay on your current meds

No Placebo Group

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?This is a study that will look at the effects and how useful investigational drug olaparib is as a neoadjuvant treatment (treatment given as to shrink a tumor before the main treatment) prior to surgery in patients with recurrent ovarian, primary peritoneal or fallopian tube cancer.

Eligibility Criteria

This trial is for adults with recurrent high-grade serous ovarian, primary peritoneal or fallopian tube cancer suitable for surgery. Participants must have responded to platinum therapy after a previous recurrence and be in good health otherwise. They should not have had certain treatments recently, no history of severe allergies to similar drugs, and agree to use contraception.

Inclusion Criteria

My last platinum-based treatment was effective.

I am 18 years old or older.

My organs and bone marrow are functioning normally.

My cancer is a recurrent high-grade serous type in the ovary, peritoneum, or fallopian tube.

My condition is considered operable for tumor removal.

I have received platinum-based chemotherapy before.

My condition allows for a biopsy before surgery.

Exclusion Criteria

My hearing loss is not severe.

I do not have any serious, uncontrolled health issues or infections.

I am not taking strong medications that affect liver enzyme CYP3A4.

I have not had radiation therapy in the last 4 weeks.

My cancer has spread to my brain.

I have lasting side effects from cancer treatment, but not hair loss.

I do not have active hepatitis B or C.

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

I have been treated with a PARP inhibitor before.

I am not taking strong medications that affect liver enzymes.

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

Participant Groups

The study tests Olaparib as an initial treatment before surgery in patients with specific types of cancer that have recurred. It aims to see how effective this drug is at shrinking tumors when given prior to the main surgical treatment.

2Treatment groups

Experimental Treatment

Group I: Olaparib Prior to Surgery, Chemotherapy/Olaparib Post SurgeryExperimental Treatment2 Interventions

Olaparib, orally, at 300 mg twice per day, for 6 weeks (+/- 2 weeks) prior to surgery. Platinum-based chemotherapy chosen by the study doctor and per standard of care after surgery. Olaparib, orally, at 300 mg twice per day, continuously, after chemotherapy.

Group II: Olaparib Prior to Surgery and Post SurgeryExperimental Treatment1 Intervention

Olaparib, orally, at 300 mg twice per day, for 6 weeks (+/- 2 weeks) prior to surgery and after surgery.