Actively Recruiting
Study of Senaparib in Combination With Temozolomide in ARID1A Mutation Associated Ovarian Cancer
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-10-27
18
Participants Needed
2
Research Sites
251 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Senaparib in Combination With Temozolomide in ARID1A Mutation Associated Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to sign informed consent
- Diagnosis of recurrent or persistent clear cell or endometrioid ovarian, fallopian tube, or primary peritoneal carcinoma with 50% clear cell or endometrioid morphology
- Presence of pathogenic or likely pathogenic ARID1A variant confirmed by next generation sequencing
- Measurable disease according to RECIST v1.1 criteria
- Received at least two prior cytotoxic regimens or have platinum-resistant or platinum-refractory disease
- Completed prior therapies with specified minimum time intervals before study start
- Able to take oral medications without gastrointestinal absorption issues
- Female patients age 18 years or older
- ECOG performance status 2
- Adequate organ and marrow function as specified
- Agree to use adequate contraception if of childbearing potential
- For patients with hepatitis B, viral load must be undetectable on suppressive therapy if applicable
- Patients with treated brain metastases must show no progression for at least 12 weeks
- Patients with prior or concurrent malignancies allowed if not interfering with study
- Cardiac function classified as NYHA class 2B or better
You will not qualify if you...
- Prior treatment with PARP inhibitors or temozolomide
- Receiving or received other investigational agents within 3 weeks prior to study
- Not recovered from prior adverse events (grade >1) unless baseline or irreversible
- History of myeloid malignancies, MDS-associated abnormalities, or T-cell lymphoblastic lymphoma/leukemia
- Clinical or radiographic bowel obstruction
- Severe or active comorbidities as judged by investigator
- Pregnant or lactating
- Known HIV infection
- Untreated brain metastases
- Allergic reactions to senaparib or temozolomide or similar compounds
- Use of strong CYP3A4 inhibitors or inducers within 3 days before dosing until study end
- Uncontrolled intercurrent illness including active infections, significant GI disease, recent major cardiovascular events, liver disease, psychiatric illness limiting compliance, or other severe conditions
- Pregnant or breastfeeding women due to potential risks
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Actively Recruiting
2
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
H
Hopkins GYN Trials
CONTACT
S
Sidney Kimmel Cancer Center Clinical Research Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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