Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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.
This is a single-arm phase 2, two-stage, non-randomized multicenter Phase 2 study designed to evaluate the clinical activity (response frequency) of senaparib and temozolomide (TMZ) in patients with recurrent or persistent clear cell or endometrioid ovarian cancer. Up to 18 adult female subjects will be enrolled and receive senaparib 80mg orally daily Days 1-28 and TMZ 20mg daily Days 1-21 of a 28 day cycle. Tumor assessments will be performed every 8 weeks for first 3 cycles then every 12 weeks thereafter until progressive disease is confirmed. Treatment will continue until either unacceptab…
Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. * Pathologically (histologically or cytologically) confirmed diagnosis of recurrent or persistent clear cell or endometrioid ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic documentation (via the pathology report) indicating at least 50% endometrioid or clear cell morphology is required. * Presence of an ARID1A pathologic variant or likely pathogenic variant ident…
Participants will receive orally 80mg daily Days 1-28 of a 28 day cycle.
Participants will receive orally 20mg daily Days 1-21 of a 28 day cycle.
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