drugset / Trial / NCT01497704
Dose-Escalation and Safety Trial of YN968D1
NaSingle-groupOpen-labelTreatment
Summary
This protocol will be divided into two parts: Part 1 will evaluate the safety and pharmacokinetics of three doses of YN968D1 after a single administration followed by a 28-Day continuous course of therapy; Part 2 will evaluate the safety and preliminary efficacy in an open-label administration of YN968D1 at the MTD or a maximum of 750 mg. All subjects in Part 1 and Part 2 of this study will be permitted to continue therapy with only safety monitoring and bimonthly assessments for progression, if the product is well tolerated and the subject has stable disease or better. Up to 72 subjects will be enrolled in this clinical trial.
Timeline
- Start
- 2012-04
- Primary completion
- 2015-02
- Completion
- 2015-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rivoceranib | Small molecule | 100 mg | Oral |
| Subject | Rivoceranib | Small molecule | 250 mg | Oral |
| Subject | Rivoceranib | Small molecule | 500 mg | Oral |
| Subject | Rivoceranib | Small molecule | 750 mg | Oral |
Indications
No indication recorded.