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 : January 9, 2023
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|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 :||May 2023|
|Estimated Primary Completion Date :||May 2024|
|Estimated Study Completion Date :||May 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Accepts Healthy Volunteers:||No|
- Patients must have been diagnosed with advanced epithelial serous ovarian cancer, primary peritoneal cancer or fallopian tube cancer
- Patients must have PARP resistant ovarian cancer, defined as progression while being treated with a PARP inhibitor.
- Patients must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.
- Patients must have received at least one but no more than five prior systemic treatment regimens
- Female patients ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Patients cannot have had primary platinum refractory cancer, i.e. documented cancer progression while receiving platinum or within one month of receipt of a platinum based regimen.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- Has a known additional malignancy that is progressing or requires active treatment. In addition, patients cannot have been diagnosed with another malignancy within 3 years of starting treatment. Exceptions include fully resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ cervical cancer, fully resected ductal carcinoma in situ, and stage IA, noninvasive grade I endometrioid endometrial cancer, that has undergone curative therapy.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include clinically active and significant carcinomatous meningitis that is excluded regardless of clinical stability.
- Has an active infection requiring systemic therapy
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
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|
|Responsible Party:||Rebecca Arend, Primary Investigator, University of Alabama at Birmingham|
|Other Study ID Numbers:||
|First Posted:||November 4, 2019 Key Record Dates|
|Last Update Posted:||January 9, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Poly(ADP-ribose) Polymerase Inhibitors
Molecular Mechanisms of Pharmacological Action