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| Sponsor: | Eisai Limited |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00459823 |
Purpose
Two-centre, open-label, non-randomized, dose-finding phase I study to determine the MTD of E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every 28 days in patients with solid tumors, for whom therapy of proven efficacy does not exist or is not longer effective.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: E7107 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Open-Label, Single-Arm, Dose Escalation Study of E7107 Administered IV (Bolus) on Days 1, 8, and 15 Every 28 Days to Patients With Solid Tumours |
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2007 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: E7107
E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every 28 days.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Patients must meet all of the inclusion criteria outlined below in order to be eligible to participate in the study.
EXCLUSION CRITERIA:
Patients with the following characteristics will not be eligible for the study:
Any of the following laboratory parameters:
Contacts and Locations| Netherlands | |
| Department of Medical Oncology, Erasmus University Medical Centre | |
| Rotterdam, Netherlands | |
| Spain | |
| Medical Oncology Service. Vall d'Hebron University Hospital | |
| Barcelona, Spain, 08035 | |
| Study Director: | Jantien Wanders, M.D. | Eisai Limited |
More Information
| Responsible Party: | Eisai Limited Medical Information Services, Eisai Limited |
| ClinicalTrials.gov Identifier: | NCT00459823 History of Changes |
| Other Study ID Numbers: | E7107-E044-102 |
| Study First Received: | April 11, 2007 |
| Last Updated: | March 23, 2009 |
| Health Authority: | Spain: Spanish Agency of Medicines and Health Products (AEMPS); The Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO) |
|
Cancer solid tumors |