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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04092270
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Endometrial High Grade Endometrioid Adenocarcinoma
  • FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
  • FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube High Grade Serous Adenocarcinoma
  • Fallopian Tube Malignant Mixed Mesodermal (Mullerian) Tumor
  • Fallopian Tube Mucinous Adenocarcinoma
  • Fallopian Tube Transitional Cell Carcinoma
  • Fallopian Tube Undifferentiated Carcinoma
  • Ovarian High Grade Serous Adenocarcinoma
  • Ovarian Seromucinous Carcinoma
  • Ovarian Undifferentiated Carcinoma
  • Platinum-Sensitive Ovarian Carcinoma
  • Primary Peritoneal Carcinosarcoma
  • Primary Peritoneal High Grade Serous Adenocarcinoma
  • Primary Peritoneal Transitional Cell Carcinoma
  • Primary Peritoneal Undifferentiated Carcinoma
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Low Grade Fallopian Tube Serous Adenocarcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Ovarian Clear Cell Adenocarcinoma
  • Recurrent Ovarian Endometrioid Adenocarcinoma
  • Recurrent Ovarian Low Grade Serous Adenocarcinoma
  • Recurrent Ovarian Malignant Mixed Mesodermal (Mullerian) Tumor
  • Recurrent Ovarian Mucinous Adenocarcinoma
  • Recurrent Ovarian Transitional Cell Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
  • Recurrent Primary Peritoneal Low Grade Serous Adenocarcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA scan
  • Pegylated Liposomal Doxorubicin Hydrochloride — DRUG
    Given IV
  • Peposertib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
May 7, 2020
Status verified
Apr 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
54 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (peposertib, PLD)
    Patients receive peposertib PO BID on days 1-21, days 1-28, or days 1-7 (depending on dose level) and pegylated liposomal doxorubicin hydrochloride IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI during screening and every 8 weeks and after 6 months of study treatment, every 12 weeks. Patients undergo ECHO during screening and every 6 months. Starting in cycle 13, patients undergo ECHO or MUGA scan every 2 cycles. Additionally, patients undergo blood sample collection throughout the study.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 3 years ]

Locations (11)

FacilityCityStateZIPSite coordinators
UCHealth University of Colorado HospitalAuroraColorado80045-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792-

Find similar trials in Aurora, CO

By research site
UCHealth University of Colorado Hospital· Aurora, COEmory University Hospital/Winship Cancer Institute· Atlanta, GADana-Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NY

Related Studies