drugset / Trial / NCT04210037
Study of APG-1252 Plus Paclitaxel in Patients With Relapsed/Refractory Small Cell Lung Cancer
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a multi-center, open-label, phase Ib/II study of combination therapy with APG-1252 plus paclitaxel in patients with relapsed/refractory small-cell lung cancer(SCLC). The phase Ib portion will be done using time-to-event continual reassessment method (TITE-CRM) methodology to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of APG-1252 with a fixed dose of paclitaxel. The phase II portion will utilize a Simon two-stage design to determine the efficacy of the combination therapy with response rate as the primary endpoint.
Timeline
- Start
- 2020-08-20
- Primary completion
- 2021-08-30
- Completion
- 2022-05-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Pelcitoclax | Small molecule | 80 mg | Intravenous |
| Subject | Pelcitoclax | Small molecule | 160 mg | Intravenous |
| Subject | Pelcitoclax | Small molecule | 240 mg | Intravenous |