clinical trial · NCT03878849
Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer
Advanced Ovarian Cancer2X-1212X-121
brief summary
The purpose of this study is to evaluate the optimal dose of 2X-121 as single agent therapy at 600 mg daily (split BID 200 mg morning + 400 mg evening) compared to 800 mg daily (split BID 400 mg morning + 400 mg evening) in recurrent, advanced ovarian cancer patients that have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible. The optimal dose will be selected based on an integrated analysis of PK/PD, safety, and efficacy data.
started
Apr 15, 2019
primary completion
Mar 1, 2027
completion
Sep 1, 2027
last updated
Aug 28, 2025
official title
Phase 2, Randomized, Prospective, Open-Label, Parallel-Arm, Dose Optimization Study to Investigate the Safety, Tolerability, PK/PD, and Anti- Tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol