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
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 46
Summary
- Conditions
- FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
- Fallopian Tube Clear Cell Adenocarcinoma
- Fallopian Tube Endometrioid Adenocarcinoma
- Recurrent Fallopian Tube Carcinoma
- Recurrent Ovarian Carcinoma
- Fallopian Tube Mucinous Adenocarcinoma
- Fallopian Tube Transitional Cell Carcinoma
- Ovarian Undifferentiated Carcinoma
- Recurrent Primary Peritoneal Carcinoma
- Recurrent Low Grade Fallopian Tube Serous Adenocarcinoma
- Recurrent Ovarian Transitional Cell Carcinoma
- Fallopian Tube Undifferentiated Carcinoma
- Platinum-Sensitive Ovarian Carcinoma
- Primary Peritoneal Transitional Cell Carcinoma
- FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
- FIGO Grade 3 Endometrial Endometrioid Adenocarcinoma
- High Grade Fallopian Tube Serous Adenocarcinoma
- Primary Peritoneal Undifferentiated Carcinoma
- Recurrent Ovarian Mucinous Adenocarcinoma
- High Grade Ovarian Serous Adenocarcinoma
- Ovarian Seromucinous Carcinoma
- Primary Peritoneal High Grade Serous Adenocarcinoma
- Recurrent Ovarian Endometrioid Adenocarcinoma
- Recurrent Primary Peritoneal Low Grade Serous Adenocarcinoma
- Recurrent Low Grade Ovarian Serous Adenocarcinoma
- Recurrent Ovarian Clear Cell Adenocarcinoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 observ...
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 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. Patients receive peposertib orally (PO) twice daily (BID) on days 1-21 or days 1-28 and pegylated liposomal doxorubicin hydrochloride intravenously (IV) on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Tracking Information
- NCT #
- NCT04092270
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Rachel N Grisham JHU Sidney Kimmel Comprehensive Cancer Center LAO
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