Status:
Recruiting
Disease Site:
Ovarian
Phase:
Phase I
Official Title:
GOG-3087 (NXP800-101) A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer
NCT ID:
NCT#05226507
Link to Full Details:
Description:
The purpose of the dose escalation phase is to evaluate the safety profile of escalating doses and dose schedules of NXP800. In the expansion phase the preliminary efficacy in subjects with ARID1a mutated ovarian clear cell and ovarian endometrioid cancers will be estimated.
Eligibility:
Female – 18 years and older
Inclusion Criteria:
- ARID1a mutated ovarian/fallopian tube/primary peritoneal cancer
- Clear cell or endometrioid histology
- Must be platinum resistant (disease progression within 6 months from the completion of platinum-based therapy)
- Patients with a BRCA mutation must have received prior treatment with a PARP inhibitor
- Must have received at least 1 but no more than 3 prior lines of systemic treatment, including at least 1 line of therapy containing bevacizumab
Exclusion Criteria:
- Patients with disease that did not respond to, or has progressed during or within 4 weeks of the last dose of first-line platinum containing chemotherapy