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Active Not RecruitingNCT04092270

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

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)

Status
Active Not Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
54 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the safety and tolerability of peposertib (M3814) in combination with pegylated liposomal doxorubicin hydrochloride (PLD) and determine the recommended phase 2 dose (RP2D) of the combination in women with recurrent ovarian cancer. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity. II. To evaluate the pharmacokinetics of peposertib (M3814) when given in combination with PLD. EXPLORATORY OBJECTIVE: I. To correlate response to treatment (as defined by response rate and progression free survival) with PLD exposure (in area under the curve \[AUC\]) and PLD associated toxicities in women with recurrent high grade serous and low grade serous ovarian cancer treated in the expansion cohorts. OUTLINE: This is a dose-escalation study of peposertib followed by a dose-expansion study. Patients receive peposertib orally (PO) twice daily (BID) on days 1-21, days 1-28, or days 1-7 (depending on dose level) and pegylated liposomal doxorubicin hydrochloride intravenously (IV) on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) during screening and every 8 weeks throughout the study and after 6 months of study treatment, every 12 weeks. Patients undergo echocardiography (ECHO) during screening and every 6 months. Starting in cycle 13, patients undergo ECHO or multigated acquisition (MUGA) scan every 2 cycles. Additionally, patients undergo blood sample collection throughout the study. After completion of study treatment, patients are followed up for 30 days.

Conditions

Interventions

TypeNameDescription
PROCEDUREBiospecimen CollectionUndergo blood sample collection
PROCEDUREComputed TomographyUndergo CT scan
PROCEDUREEchocardiography TestUndergo ECHO
PROCEDUREMagnetic Resonance ImagingUndergo MRI
PROCEDUREMultigated Acquisition ScanUndergo MUGA scan
DRUGPegylated Liposomal Doxorubicin HydrochlorideGiven IV
DRUGPeposertibGiven PO

Timeline

Start date
2020-05-07
Primary completion
2026-06-01
Completion
2026-06-01
First posted
2019-09-17
Last updated
2026-04-17

Locations

11 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04092270. Inclusion in this directory is not an endorsement.

A Study Combining the Peposertib (M3814) Pill With Standard Chemotherapy in Patients With Ovarian Cancer With an Expansi (NCT04092270) · Clinical Trials Directory