A Study Combining the Peposertib (M3814) Pill With Standard Chemotherapy in Patients With Ovarian Cancer With an Expansion in High Grade Serous Ovarian Cancer and Low Grade Serous Ovarian Cancer (NCT04092270)
A Phase I/Ib Dose Escalation Study of Pegylated Liposomal Doxorubicin (PLD) With Peposertib (M3814) in Platinum - Resistant or Ineligible Ovarian and Related Cancers With Planned Expansions in High Grade Serous (HGSOC) and Low Grade Serous Ovarian Cancer (LGSOC)
🩺 Plain-English Summary (8th-Grade Level)
This phase I trial studies the side effects and best dose of peposertib when given together with pegylated liposomal doxorubicin hydrochloride in treating patients with high or low grade ovarian cancer that has come back after a period of improvement (recurrent). Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pegylated liposomal doxorubicin 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. Giving peposertib and pegylated liposomal doxorubicin hydrochloride may work better in treating patients with ovarian cancer compared to pegylated liposomal doxorubicin hydrochloride alone.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (31 items) and avoid the listed exclusions (20 items).
Location: UCHealth University of Colorado Hospital — Aurora, Colorado
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients are excluded from the dose-escalation phase of the study if they are eligible for any available therapies known to confer clinical benefit
- Inability to swallow and/or absorb oral medication (patients with a drainage peg are ineligible)
- Patients may not have received prior anthracyclines (doxorubicin or pegylated liposomal doxorubicin) for treatment of their ovarian cancer
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia, thyroid dysfunction, or neuropathy
- Patients who are receiving any other investigational agents within 28 days prior to start of treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to peposertib (M3814) or pegylated liposomal doxorubicin
- Patients who cannot discontinue concomitant medications or herbal supplements that potentially interact with peposertib (M3814)
- The following categories of medications and herbal supplements must be discontinued prior to starting study treatment:
- Strong inducers/inhibitors of CYP3A4/5, CYP2C9, and CYP2C19
- Substrates with a narrow therapeutic index that are metabolized by CYP1A2, 2B6, 2C8, and 3A4/5
- Use caution with other substrates of CYP3A4/5, CYP1A2, CYP2B6, CYP2C8 and substrates of P-gp, BCRP, OCT1, OAT3, OATP1B1, OATP1B3, MATE1, and MATE-2K with a narrow therapeutic index. Close monitoring is advised
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (11 Sites)
- UCHealth University of Colorado Hospital — Aurora, Colorado
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Memorial Sloan Kettering Monmouth — Middletown, New Jersey
- Memorial Sloan Kettering Westchester — Harrison, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma
- University of Pittsburgh Cancer Institute (UPCI) — Pittsburgh, Pennsylvania
- University of Virginia Cancer Center — Charlottesville, Virginia
- University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.