Trial of M4344 and Niraparib in Patients With Poly (ADP-ribose) Polymerase (PARP) Resistant Recurrent Ovarian Cancer (PARP)
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|ClinicalTrials.gov Identifier: NCT04149145|
Recruitment Status : Not yet recruiting
First Posted : November 4, 2019
Last Update Posted : August 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Recurrent||Drug: M4344+Niraparib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trial of M4344 and Niraparib in Patients With PARP Resistant Recurrent Ovarian Cancer|
|Estimated Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 1, 2027|
all PARP resistant, recurrent ovarian cancer
The first phase will be a 3+3 design of fixed dose Niraparib by mouth (PO) every day (QD) and M4344 will be escalated from 100-200 mg PO QD (28-day cycle). There will be a 4-week lead in with niraparib only.
Other Name: PARPi+ATRi
In the second phase eligible patients will receive combination Niraparib + the determined dose of M4344 from the first phase.
Other Name: PARPi+ATRi
- Percentage of patients with treatment emergent adverse events as defined by CTCAE v.4.03 [ Time Frame: Baseline through 1 year ]Number and percentage of patients with treatment emergent adverse events and toxicity based upon CTCAE v.4.03 scoring.
- Maximum tolerated dose (MTD) of M4344 and Niraparib as defined by CTCAE 4.03 [ Time Frame: Baseline through 1 year ]To determine the MTD of M4344 and Niraparib during the dose escalation as defined by CTCAE v.4.03
- Overall Response Rate (ORR) as defined by RECIST v.1.1 [ Time Frame: Baseline through 6 months ]To determine response rate among ovarian cancer patients that have become resistant to PARPi who are treated with ATRi + Niraparib as defined by RECIST v.1.1.
- Percentage progression free survival (PFS) as defined by RECIST v.1.1 [ Time Frame: Baseline through 6 months ]To determine percentage of patients who remain progression free at 6 months (%PFS) among ovarian cancer patients that have become resistant to PARPi who are treated with ATRi + Niraparib as defined by RECIST v.1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04149145
|Contact: Anna Burton, MSNfirstname.lastname@example.org|
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|
|Contact: Anna Burton, MSN 205-934-6454 email@example.com|
|Principal Investigator: RebeccA C Arend, MD, MSPH|
|Principal Investigator:||Rebecca C Arend, MD, MSPH||University of Alabama at Birmingham|