drugset / Trial / NCT01949870
Selumetinib (AZD6244, ARRY-142886) J-BTC Phase 1 Study
NaSingle-groupOpen-labelTreatment
Summary
The objective of this study is to investigate the safety and tolerability of oral dose of selumetinib in combination with chemotherapies (cisplatin and gemcitabine) in Japanese patients with advanced biliary tract cancer (BTC). In addition, the pharmacokinetic (PK) profile of selumetinib and chemotherapies will be investigated. Also, the Maximum tolerated dose (MTD) of selumetinib in combination with chemotherapies for Japanese BTC patients will be identified, if possible.
Timeline
- Start
- 2013-10
- Primary completion
- 2014-08
- Completion
- 2014-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | — | — |
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Selumetinib | Small molecule | 25 mg | Oral |
| Subject | Selumetinib | Small molecule | 50 mg | Oral |
| Subject | Selumetinib | Small molecule | 75 mg | Oral |
Indications
No indication recorded.