A Dose Escalation Study of E7107 Administered IV (Bolus) on Days 1, 8, and 15 Every 28 Days to Patients With Solid Tumours

Phase 1

Suspended

• Conditions: Cancer
• Interventions: Drug: E7107

• Registration Number: NCT00459823
• Lead Sponsor: Eisai Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-11
• Study First Submitted QC: 2007-04-11
• Study First Posted: 2007-04-13
• Study Start: 2007-05
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-23
• Last Update Posted: 2009-03-24
• Primary Completion: 2009-06

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	E7107	-

Primary Outcome Measures

Name	Time	Method
To determine MTD of E7107. Safety and tolerability.	Every six weeks.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of E7107. Evaluation of anti-tumor activity. To investigate potential biomarkers of pharmacodynamic effect.	Every 21 days.

Trial Locations

Locations (2)

Medical Oncology Service. Vall d'Hebron University Hospital; 🇪🇸 Barcelona, Spain

Department of Medical Oncology, Erasmus University Medical Centre; 🇳🇱 Rotterdam, Netherlands