Cirtuvivint + Olaparib for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byBradley Corr

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to learn about the safety and tolerability of Cirtuvivint in combination with Olaparib in platinum resistant ovarian cancer. The study also aims to determine the recommended dose of the combination therapy. If a participant is a good fit for the study, and they enroll in the study, they will: * Visit the clinic often at the beginning of the study for physical exams, blood draws, vital signs, and other study and routine care procedures. After the first two months participants will visit the clinic every 28 days. * Take the study medications, Cirtuvivint and Olaparib. Participants will take Olaparib every day. Participants will either take Cirtuvivint 5 days per week or 2 days per week.

Eligibility Criteria

This trial is for individuals with ovarian cancer, including fallopian tube and peritoneal cancers, that are resistant to platinum-based chemotherapy. Participants must have a gene defect related to breast cancer (BRCA) or a similar repair deficiency. They should be able to attend frequent clinic visits.

Inclusion Criteria

Provision to sign and date the consent form

I am a woman aged 18 or older.

I can take care of myself and am up and about more than half of my waking hours.

+11 more

Exclusion Criteria

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

Patients deemed otherwise clinically unfit for clinical trial per investigators discretion

Prior known hypersensitivity reaction to study drugs and/or any of their excipients

+12 more

Participant Groups

The study tests the safety and best dose of Cirtuvivint combined with Olaparib in treating platinum-resistant ovarian cancer. Patients will take Olaparib daily and Cirtuvivint either five days or two days weekly, with regular clinic visits for monitoring.

2Treatment groups

Experimental Treatment

Group I: Dose Regimen 2Experimental Treatment2 Interventions

Patients on Dose Regimen 2 will take 300 mg PO BID olaparib in combination with 120 mg PO cirtuvivint for 2 days on and 5 days off

Group II: Dose Regimen 1Experimental Treatment2 Interventions

Patients on Dose Regimen 1 will take 300mg PO BID olaparib in combination with 80mg PO cirtuvivint for 5 days on and 2 days off.