drugset / Trial / NCT01676753
Phase 1b Trial of Dinaciclib With Pembrolizumab for Advanced Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this trial is to determine the safety and tolerability (maximum tolerated dose (MTD)) of weekly dinaciclib in combination with pembrolizumab in patients with advanced breast cancer. Once this is defined, dose expansion will be performed at this MTD in patients with metastatic or locally advanced and unresectable triple negative breast cancer, to evaluate the efficacy of combined dinaciclib and pembrolizumab.
Timeline
- Start
- 2016-12-28
- Primary completion
- 2020-06-30
- Completion
- 2022-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dinaciclib | Small molecule | 12 mg/m2 | Intravenous |
| Subject | Dinaciclib | Small molecule | 18 mg/m2 | Intravenous |
| Subject | Dinaciclib | Small molecule | 25 mg/m2 | Intravenous |
| Subject | Dinaciclib | Small molecule | 33 mg/m2 | Intravenous |
| Subject | Dinaciclib | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |