A Study of E7050 Administered Orally to Patients With Advanced Solid Tumors
- Registration Number
- NCT00921869
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
The purpose of this study is to determine the maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally twice daily to patients with advanced solid tumors.
- Detailed Description
Phase I, open-label, dose-escalation study to determine the maximum tolerated dose (MTD) of E7050 given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 E7050 -
- Primary Outcome Measures
Name Time Method Determination of the MTD of E7050 given orally twice daily. MTD is the highest dose at which no more than 1 out of 6 patients experiences dose-limiting toxicity (DLT) During the Run-in Phase and the first 5 weeks of treatment
- Secondary Outcome Measures
Name Time Method Dose-limiting toxicities. During the Run-in Phase and the first 5 weeks of treatment Incidence and severity of adverse events and their drug relationship. Throughout the entire study Pharmacodynamic (PD) biomarker analysis of blood and tumor tissue samples. During Cycle 1 (28 days) and Day 15 of Cycle 2 for blood; on Day 22 of Cycle 1 for optional tumor biopsies PK of blood and urine During the Run-in Phase, Cycle 1 (28 days) and Day 15 of Cycle 2 for blood; Day 28 of Cycle 1 for urine Best overall tumor response, duration of response and stable disease, assessed by Response Evaluation Criteria in Solid Tumors. Every 4 weeks for complete and partial response; by 7th week for stable disease