drugset / Trial / NCT02644278
First-in-Human Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of VX-984 in Combination With Chemotherapy
Phase 1
Completed
15 enrolled
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany · collab
SequentialOpen-labelTreatment
Summary
The purpose of this study was to evaluate the safety and tolerability of VX-984 (M9831) administered alone and in combination with pegylated liposomal doxorubicin (PLD), and to determine the maximum tolerated dose (MTD) and preliminary evidence of efficacy of VX-984 in combination with PLD in participants with advanced solid tumors.
Timeline
- Start
- 2016-02-29
- Primary completion
- 2017-10-19
- Completion
- 2017-10-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VX-984 | Unknown | 120 mg | Oral |
| Subject | VX-984 | Unknown | 240 mg | Oral |
| Subject | VX-984 | Unknown | 480 mg | Oral |
| Subject | VX-984 | Unknown | 720 mg | Oral |
| Background | Pegylated liposomal doxorubicin | Unknown | 40 mg/m2 | Intravenous |