drugset / Trial / NCT03878849
Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer
Phase 2
Recruiting
40 enrolled
Allarity Therapeutics
Alcedis GmbH · collabAmarex Clinical Research · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-04-15
- Primary completion
- 2027-03
- Completion
- 2027-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 2X-121 | Small molecule | 600 mg | — |
| Subject | 2X-121 | Small molecule | 800 mg | — |