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

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.

Conditions

• Endometrial High Grade 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
• FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
• FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
• 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

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT scan

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

DRUG

Pegylated Liposomal Doxorubicin Hydrochloride

Given IV

DRUG

Peposertib

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Rachel N Grisham · JHU Sidney Kimmel Comprehensive Cancer Center LAO

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-07

Primary Completion

2026-06-01

Completion

2026-06-01

FDA Drug

Yes

Countries

• United States

Study Locations