Trials / Withdrawn
WithdrawnNCT04149145
Trial of M4344 and Niraparib in Patients With Poly (ADP-ribose) Polymerase (PARP) Resistant Recurrent Ovarian Cancer
Trial of M4344 and Niraparib in Patients With PARP Resistant Recurrent Ovarian Cancer
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Alabama at Birmingham · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to find out if a new drug, M4344, is safe and has beneficial effects when given in combination with the PARP inhibitor, Niraparib, in women with recurrent ovarian cancer that has progressed while on a PARP inhibitor.
Detailed description
The primary, secondary, and exploratory objective are to assess the safety of the combination of M4344 and Niraparib in a phase 1 trial of patients with PARP resistant recurrent ovarian cancer; to determine the response rate and percentage of participants who remain progression free survival (PFS) at 6 months (%PFS) among ovarian cancer participants that have become resistant to poly (adenosine diphosphate \[ADP\]) ribose polymerase inhibitors (PARPi) who are treated with ataxia telangiectasia and Rad3-related protein inhibitors (ATRi) + Niraparib in the dose expansion cohort; and to identify potential biological predictors of response and progression of disease with the combination of M4344 and Niraparib.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | M4344+Niraparib | 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. |
| DRUG | M4344+Niraparib | In the second phase eligible patients will receive combination Niraparib + the determined dose of M4344 from the first phase. |
Timeline
- Start date
- 2023-05-01
- Primary completion
- 2024-05-01
- Completion
- 2027-05-01
- First posted
- 2019-11-04
- Last updated
- 2023-06-07
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04149145. Inclusion in this directory is not an endorsement.