PM01183 in combination with Gemcitabine (v 1.0 10/12/2010)

• Research type

  Research Study

• Full title

  Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination with Gemcitabine in Non-heavily pretreated Patients with Selected Advanced Solid Tumors.

• IRAS ID

  74334

• Contact name

  Martin Forster

• Eudract number

  2010-024239-18

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a phase I study of a commonly used oncology drug (gemcitabine) 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 start with a gemcitabine dose of 800 mg/m2 and escalate the dose of PM01183 up to 3.5 mg, both delivered on day 1 and day 8 of a 21 day schedule. If it is appropriate to test more levels, gemcitabine will then be escalated to 1000 mg/m2 and subsequently PM01183 escalated at intervals of 0.5 mg/day. Patients will be included in cohorts of 3 patients at each dose level. If less than one third of patients experienced unacceptable toxicities (known as Dose Limiting Toxicities) at any given dose level explored during their first cycle, dose will be further escalated according to the protocol. Depending on the toxicities found at each dose level, cohorts might be expanded up to 6 patients. When unacceptable toxicities arise in one third of the patients included at a certain dose level, that dose level will be defined as the Maximum Tolerated Dose. The Recommended Dose is defined as the highest dose level at which less than 1/3 of the patients have Dose Limiting Toxicities.According to preclinical studies, we believe that the combination of both drugs might be beneficial for patients with cancer. The tumour types selected in this study are based on the standard clinical use of gemcitabine in patients with solid tumours, as well as on potential activity of PM01183.Patients will remain on treatment whilst their disease remains controlled, unacceptable toxicities arises or the 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/0137

• Date of REC Opinion

  13 Jun 2011

• REC opinion

  Further Information Favourable Opinion