drugset / Trial / NCT02551055
MLN1117 in Combination With Docetaxel, Paclitaxel, and Other Investigational Anticancer Agents to Treat Participants With Gastric and Gastroesophageal Adenocarcinoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the maximum tolerated dose (MTD) or recommended Part 2 dose, safety and efficacy of MLN1117 (TAK-117) in combination with docetaxel, paclitaxel, investigational TAK-659 or investigational alisertib in adult participants with advanced and metastatic gastric or gastroesophageal adenocarcinoma. The study consists of a dose escalation phase (Part 1) and a dose expansion phase (Part 2).
Timeline
- Start
- 2015-10-15
- Primary completion
- 2017-02-17
- Completion
- 2017-02-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alisertib | Small molecule | 40 mg | Oral |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Serabelisib | Small molecule | 200 mg | Oral |
| Subject | Serabelisib | Small molecule | 300 mg | Oral |
| Subject | Serabelisib | Small molecule | 600 mg | Oral |
| Subject | mivavotinib | Small molecule | 100 mg | Oral |