PM01183 in combination with Doxorubicin v 1.0 (13/12/2010)
Research type
Research Study
Full title
Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in combination with Doxorubicin in Non-heavily pretreated Patients with Selected Advance Solid Tumors.
IRAS ID
74309
Eudract number
2010-024291-25
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
This is a phase I study of a commonly used oncology drug (doxorubicin) in combination with an experimental drug (PM01183). The aim of this study is to define the Maximum Tolerated dose and the recommended dose of this combination. We will use a fixed dose of doxorubicin (50mg/m2) and will escalate the dose of PM01183. Patients will be included in cohorts of 3 patients at each dose level. In case no Toxicites are found, dose level will be escalated according to the protocol. Depending on the toxicities found at each dose level, cohorts might be expanded up to 6 patients. When unacceptable toxicites arise in one third of the patients included at a certain dose level) that dose level will be defined as Maximum Tolerated dose. The recommended Dose will be defined as the highest dose level at which less than 1/3 of the patients have unacceptable toxicities (know as Dose limiting Toxicities).Accoding to preclinical studies, we believe that the combination of both drugs might be beneficial por patients. The tumor type selection in this study is based on the standard clinical use of doxorubicin in solid tumor patients as well as on preclinical evidence of potential activity of PM01183.Patients will remain on treatment whilst their disease remains controlled, unacceptable toxicities arises or in case patient withdraws his/her consent.This study will be carried out in one site in the United Kingdom (UCLH, London) and two sites in Spain.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
11/SC/0136
Date of REC Opinion
13 Jun 2011
REC opinion
Further Information Favourable Opinion