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Alkylating agents

RP-6306 + Chemotherapy for Ovarian and Uterine Cancer (GyneRep Trial)

Phase 1

Waitlist Available

Led By Stephanie Lheureux, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females ≥18 years old at the time of signature of the consent form

All patients must have histologically proven, locally advanced or metastatic recurrent ovarian and uterine cancer. Patients will be eligible only if available curative therapy does not exist

Must not have

Chemotherapy or small molecule antineoplastic agent given within 21 days or <5 half-lives, whichever is shorter, prior to first dose of study treatment

Patients who are unable to swallow oral medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess an experimental drug combo to treat ovarian/uterine cancer, to determine its safety, tolerability and effectiveness.

Who is the study for?

This trial is for women over 18 with advanced or recurrent ovarian and uterine cancer that's TP53 mutated, who can take oral meds, have good organ function, are not pregnant, and agree to use contraception. Excluded are those with recent major surgery, life-threatening conditions, uncontrolled infections like HIV/Hepatitis B/C, severe liver impairment or heart disease.

What is being tested?

The study tests RP-6306 combined with carboplatin and paclitaxel in patients. It aims to find the safest dose (MTD) and see how well it works (efficacy). The first part sets the dose; the second part expands on safety data and preliminary effectiveness.

What are the potential side effects?

Possible side effects include reactions related to drug infusion, blood count changes leading to increased infection risk or bleeding problems, nerve damage (neuropathy), fatigue, digestive issues like nausea or constipation from chemotherapy drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged 18 or older.

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My ovarian or uterine cancer is advanced, cannot be cured with existing treatments.

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I have tissue samples available for genetic testing.

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My ovarian or uterine cancer is aggressive and has a specific genetic abnormality.

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I can be treated again with carboplatin and paclitaxel.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had chemotherapy or targeted cancer drugs within the last 3 weeks.

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I cannot swallow pills.

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I have been treated with a WEE1 or PKMYT1 inhibitor before.

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I haven't had serious heart issues or uncontrolled electrolyte problems in the last 6 months.

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My liver is not working well (Child-Pugh Class B or C).

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I haven't taken strong CYP3A affecting drugs or cancer treatments in the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Disease Control Rate

Duration of Response

Objective response rate

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B - Dose ExpansionExperimental Treatment3 Interventions

RP6306, 40 mg orally at the best schedule determined in Part A. Carboplatin, AUC 5 intravenously, on Day 1 of every 21-day cycle. Paclitaxel, 175 mg/m2 intravenously, on Day 1 every 21-day cycle.

Group II: Part A - Dose EscalationExperimental Treatment3 Interventions

RP6306, 40 mg orally, twice a day, continuously or on Days 1 to 3, for 1 or 2 weeks, every 21-day cycle. Carboplatin, AUC 5 intravenously, on Day 1 of every 21-day cycle. Paclitaxel, 175 mg/m2 intravenously, on Day 1 of every 21-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Paclitaxel

2011

Completed Phase 4

~5450