Phase I trial of E7389 liposomal formulation (V1.0)
Research type
Research Study
Full title
An Open-label, Multicenter, Multiple Dose, Phase 1 Study to Establish the Maximum Tolerated Dose of E7389 Liposomal Formulation in Patients with Solid Tumors
IRAS ID
109875
Contact name
Thomas Evans
Contact email
Sponsor organisation
Eisai Limited
Eudract number
2012-001184-69
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
The study is designed to find the safest and most effective dose of E7389 liposomal formulation and the most appropriate schedule for its administration. In the first part of the study, the Dose Escalation Part, we want to find out what is the best dose and schedule. Three patients will be treated with relatively low doses of the drug with pre-defined administration'schedules of every 2 weeks, 3 weeks or 4 weeks. If this low dose does not cause unacceptable side effects, the dose will be increased for the next three patientsparticipating in the study. Increasing doses will be given to each set of three patientsuntil side effects are seen which are considered not tolerable to those patients When this happens the dose will not be increased any more and the study will move to the Expansion Part where additional patients will receive the highest tolerable dose to confirm it is safe for patients and has some beneficial effect against cancer, and therefore maybe used for a treatment for cancer in the future.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
12/NE/0291
Date of REC Opinion
10 Oct 2012
REC opinion
Further Information Favourable Opinion