An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- E7080
- Conditions
- Cancer: Solid Tumors
- Sponsor
- Eisai Inc.
- Enrollment
- 27
- Primary Endpoint
- Maximum Tolerable Dose (MTD) of E7080 Repeatedly Administered Twice a Day
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to determine the maximum tolerable dose (MTD) and the related effects of E7080 administered to patients with solid tumors that are resistant to approved existing anti-tumor therapies, or for which no appropriate treatment is available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Intervention: E7080
Outcomes
Primary Outcomes
Maximum Tolerable Dose (MTD) of E7080 Repeatedly Administered Twice a Day
Time Frame: up to 4 weeks
The MTD was defined as the highest dose at which no dose limiting toxicity (DLT) was experienced by the first 3 patients in that cohort, or the dose at which a DLT was experienced by no more than 1 of 6 patients evaluable for toxicity.
DLT of E7080 Repeatedly Administered Twice a Day
Time Frame: up to 4 weeks
DLTs were defined as grade 3 or more platelet count decrease, grade 4 neutropenia, any grade 3 or more nonhematologic toxicity (with exceptions of grade 4 hypertension not controlled by any antihypertensive drugs and grade greater than or equal to 3 vomiting and diarrhea not controlled by antiemetic or antidiarrheal drugs), and failure to administer more than 75% of the planned doses of E7080 during the same cycle due to toxicity.
Secondary Outcomes
- To Elucidate the Pharmacokinetic Profile of E7080(Every 3 weeks)
- To Make Exploratory Analyses of Pharmacodynamic Markers(Every 3 weeks)
- Number of Participants With Adverse Events / Serious Adverse Events(Until tumor progression, unacceptable toxicity, or withdrawal due to other reasons.)
- Determine the Clinical Dose for Phase II Study Based on Safety and Pharmacokinetic Profile(Every 3 weeks)
- Evaluate the Anti-tumor Activity of E7080(Every 3 weeks)