Chemotherapy + Berzosertib for Ovarian Cancer

Recruiting at 14 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: CYP3A4 inhibitors/inducers

Disqualifiers: Brain metastases, Li Fraumeni, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 21-day cycles, repeated until disease progression or unacceptable toxicity

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and berzosertib when given together with carboplatin in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent) and has spread to other places in the body (metastatic). Chemotherapy drugs, such as carboplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving berzosertib with chemotherapy (carboplatin and gemcitabine hydrochloride) may work better in treating patients with ovarian, primary peritoneal, or fallopian tube cancer compared to chemotherapy alone.

Who Is on the Research Team?

Andrea E. Wahner Hendrickson, M.D.

Principal Investigator

Mayo Clinic Cancer Center LAO

Are You a Good Fit for This Trial?

This trial is for adults with high-grade serous or endometrioid ovarian, peritoneal, or fallopian tube cancer that's metastatic and beyond cure. Participants must have measurable disease, be in their first or second platinum-sensitive recurrence (recurrence >6 months after last platinum therapy), and have adequate organ function. They can't join if they've had more than two prior platinum treatments, recent chemotherapy/radiotherapy, known brain metastases, allergies to the drugs being tested, are pregnant/breastfeeding, or have certain genetic syndromes.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

My cancer is a specific type that has spread and cannot be cured with surgery or radiation.

I have a tumor that can be measured with scans or exams.

Exclusion Criteria

I will not receive bevacizumab as part of this study's treatment.

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

My cancer did not respond to platinum-based treatment or it came back after such treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation/Safety Lead-in

Assess safety and tolerability of the combination therapy and determine the dose for the expansion cohort

Up to 28 days

Multiple visits for dose escalation and monitoring

Treatment

Patients receive carboplatin, gemcitabine hydrochloride, and berzosertib in 21-day cycles

21-day cycles, repeated until disease progression or unacceptable toxicity

IV administration on days 1, 2, 8, and 9 of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Berzosertib
• Carboplatin
• Gemcitabine Hydrochloride

Trial Overview The trial tests how well patients respond to a combination of Carboplatin and Gemcitabine Hydrochloride with Berzosertib versus standard treatment alone. It aims to find the best dose of these drugs together while assessing side effects when treating recurrent/metastatic ovarian, primary peritoneal or fallopian tube cancer.

How Is the Trial Designed?

Group I: Treatment (carboplatin, gemcitabine hydrochloride, VX-970) Experimental Treatment 5 Interventions

Patients receive carboplatin IV over 30 minutes on day 1, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and berzosertib IV over 60 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+