OncoMatch/Clinical Trials/NCT06617923
Study of Senaparib in Combination With Temozolomide in ARID1A Mutation Associated Ovarian Cancer
Is NCT06617923 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Senaparib and Temozolomide for ovary cancer.
Treatment: Senaparib · Temozolomide — This is a phase 2 study to test the effectiveness (anti-tumor activity) of the combination of the study drugs, Senaparib and Temozolomide, in patients with clear cell or endometrioid ovarian cancers that have ARID1A pathologic variants.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Biomarker criteria
Required: ARID1A pathogenic mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: cytotoxic chemotherapy
Patients must have received at least two prior cytotoxic regimens or have platinum-resistant (defined as having progressed within 6 months of last platinum therapy) or platinum-refractory (having progressed during primary platinum therapy) disease.
Cannot have received: PARP inhibitor
Prior treatment with a poly ADP ribose polymerase (PARP) inhibitor
Cannot have received: alkylating agent (temozolomide)
Prior treatment with ... temozolomide
Cannot have received: investigational agent
Patients who are currently receiving or have previously received any other investigational agents within 3 weeks prior to entering the study.
Lab requirements
Blood counts
Absolute Neutrophil Count ≥1,000/mcL; Differential with no clinically significant morphologic abnormalities on CBC; Hemoglobin ≥9 g/dL; Platelets ≥100,000/mcL
Kidney function
Creatinine -OR- Glomerular Filtration Rate ≤ institutional upper limit normal (ULN) -OR- ≥50 mL/min/1.73 m2 for patients with creatinine levels above institutional ULN
Liver function
AST (SGOT) or ALT (SGPT) ≤3 × institutional ULN; Total Bilirubin ≤1.5 × institutional ULN; Direct bilirubin ≤ ULN for subjects with total bilirubin > 1.5 x ULN (patients with isolated indirect bilirubin elevations and a history of Gilbert's Syndrome are eligible)
Cardiac function
NYHA Functional Classification class 2B or better
Patients must have adequate organ and marrow function as defined below: Absolute Neutrophil Count ≥1,000/mcL; Differential with no clinically significant morphologic abnormalities on CBC; Hemoglobin ≥9 g/dL; Platelets ≥100,000/mcL; AST (SGOT) or ALT (SGPT) ≤3 × institutional ULN; Total Bilirubin ≤1.5 × institutional ULN; Direct bilirubin ≤ ULN for subjects with total bilirubin > 1.5 x ULN (patients with isolated indirect bilirubin elevations and a history of Gilbert's Syndrome are eligible); Creatinine -OR- Glomerular Filtration Rate ≤ institutional upper limit normal (ULN) -OR- ≥50 mL/min/1.73 m2 for patients with creatinine levels above institutional ULN. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland
- University of Pennsylvania/Abramson Cancer Center · Philadelphia, Pennsylvania
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