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

Recurrent Ovarian Carcinoma Clinical Trial

Official title:
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 Recruiting

Clinical Trial 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.

Clinical Trial 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 undergo blood sample collection cycle 1 weeks 1 and 3. 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. After completion of study treatment, patients are followed up for 30 days. ;

Study Design

Related Conditions & MeSH terms

Adenocarcinoma
Adenocarcinoma, Mucinous
Carcinoma
Carcinoma, Endometrioid
Carcinoma, Ovarian Epithelial
Carcinoma, Transitional Cell
Carcinosarcoma
Cystadenocarcinoma
Fallopian Tube Carcinosarcoma
Fallopian Tube Clear Cell Adenocarcinoma
Fallopian Tube Endometrioid Adenocarcinoma
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
Mixed Tumor, Mullerian
Ovarian Neoplasms
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
Recurrence
Recurrent Fallopian Tube Carcinoma
Recurrent Low Grade Fallopian Tube Serous Adenocarcinoma
Recurrent Ovarian Carcinoma
Recurrent Ovarian Carcinosarcoma
Recurrent Ovarian Clear Cell Adenocarcinoma
Recurrent Ovarian Endometrioid Adenocarcinoma
Recurrent Ovarian Mucinous Adenocarcinoma
Recurrent Ovarian Transitional Cell Carcinoma
Recurrent Primary Peritoneal Carcinoma
Recurrent Primary Peritoneal Low Grade Serous Adenocarcinoma

Clinical Trial Details

NCT number	NCT04092270
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Recruiting
Phase	Phase 1
Start date	May 7, 2020
Completion date	September 1, 2024

View Details

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