Active — Not RecruitingPhase 1

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

Canada6 participantsStarted 2024-03-20

Plain-language summary

This is a phase 1 study to evaluate investigational drug RP-6306 in combination with carboplatin and paclitaxel in patients with TP53 mutated ovarian or uterine cancer. The dose escalation part of the study will determine the maximum tolerated dose (MTD) and recommended Phase 2 Dose (RP2D) and schedule of RP-6306 in combination with carboplatin and paclitaxel and the dose expansion will further assess the safety and tolerability as well as determine the preliminary efficacy of RP-6306 in combination with carboplatin and paclitaxel.

Who can participate

Age range18 Years

SexFEMALE

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Exclusion criteria

✕. Unstable angina pectoris
✕. Congestive heart failure
✕. Acute myocardial infarction
✕. Conduction abnormality not controlled with pacemaker or medication
✕. Significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible)
✕. Clinically relevant electrolyte abnormalities

What they're measuring

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

Timeframe: 21 days

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

Timeframe: 21 days

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

Timeframe: 21 days

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

Timeframe: 21 days

Trial details

NCT IDNCT06107868

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-31

View on ClinicalTrials.gov More Recurrent Ovarian Cancer trials