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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

GyneRep Trial 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.Check my eligibility

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.See study design

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.

GyneRep Trial 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.

GyneRep Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of dose-limiting toxicities (DLTs) at Dose Level -1

Frequency of dose-limiting toxicities (DLTs) at Dose Level -2

Frequency of dose-limiting toxicities (DLTs) at Dose Level 1

+1 more

Secondary outcome measures

Average change in tumour size

Disease Control Rate

Duration of Response

+4 more

GyneRep 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

~6670

Paclitaxel

2011

Completed Phase 4

~5380

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,468 Previous Clinical Trials

484,495 Total Patients Enrolled

15 Trials studying Ovarian Cancer

3,483 Patients Enrolled for Ovarian Cancer

Stephanie Lheureux, MDPrincipal InvestigatorThe Princess Margaret Cancer Foundation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent can Part A - Dose Escalation be considered a risk to individuals?

"Our experts at Power rated the safety of Part A - Dose Escalation with a score of 1, as it is currently in Phase 1 trials and there is only limited evidence to support its efficacy."

Answered by AI

Are there any slots open for enrollment in this clinical experiment?

"The most up-to-date information from clinicaltrials.gov indicates that this medical study is no longer seeking participants, having first been posted on December 4th 2023 and last edited on October 25th of the same year. Despite not currently recruiting patients, there are still 1359 other trials actively enrolling individuals at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 1 Study of RP-6306 With Carboplatin and Paclitaxel in TP53 Ovarian and Uterine Cancer

2024. "Phase 1 Study of RP-6306 With Carboplatin and Paclitaxel in TP53 Ovarian and Uterine Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06107868.

All > Uterine Cancer > Recurrent Ovarian Cancer