drugset / Trial / NCT01047007
A Dose Escalation Study of Adavosertib(MK1775) in Combination With 5-FU or 5-FU/CDDP in Patients With Advanced Solid Tumor (1775-005
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The study evaluates safety of adavosertib in monotherapy, and in combination with 5-Fluorouracil (5-FU) alone or with 5-FU/cis-diamminedichloroplatinum (CDDP) in Japanese participants with solid tumor. The primary hypothesis is that adavosertib is safe and tolerable in participants with locally advanced or metastatic solid tumors.
Timeline
- Start
- 2010-01-18
- Primary completion
- 2011-06-15
- Completion
- 2011-06-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adavosertib | Small molecule | 20 mg | Oral |
| Subject | Adavosertib | Small molecule | 65 mg | Oral |
| Background | Cisplatin | Other / unclassified | 60 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 1000 mg/m2 | Intravenous |