drugset / Trial / NCT05952128
Phase Ib/II Study of Fluzoparib in Combination With Dalpiciclib in Patients With Locally Advanced or Metastatic Sarcoma
Phase 2
Unknown
50 enrolled
Sun Yat-sen University
Jiangsu Hengrui Pharmaceutical Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a single-center, single-arm phase Ib / II clinical trial, which was included with two phase. The main purpose of the phase Ib part was to determine the dose-limiting toxicity ( DLT ), maximum tolerated dose ( MTD ), and recommended dose ( RP2D ) of Fluzoparib combined with Dalpiciclib in patients with locally advanced or metastatic sarcoma. The phase II part is mainly to observe the efficacy and safety of Fluzoparib combined with Dalpiciclib.
Timeline
- Start
- 2023-07-01
- Primary completion
- 2024-12-01
- Completion
- 2025-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dalpiciclib | Small molecule | 100 mg | Oral |
| Subject | Dalpiciclib | Small molecule | 125 mg | Oral |
| Subject | Dalpiciclib | Small molecule | 150 mg | Oral |
| Subject | Fluzoparib | Small molecule | 100 mg | Oral |