Spots Global Cancer Trial Database for A Phase I Clinical Study of Oral CP-4126 in Patients With Advanced Solid Tumour

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Trial Identification

Brief Title: A Phase I Clinical Study of Oral CP-4126 in Patients With Advanced Solid Tumour

Official Title: A Phase I Clinical Study of Oral CP-4126 in Patients With Advanced Solid Tumour

Study ID: NCT00778128

Conditions

Solid Tumors

Interventions

CP-4126

Gemcitabine

Study Description

Brief Summary: At step 1, patients with advanced solid tumors will receive CP-4126 capsules following a dose escalation schedule until the maximum tolerated dose is reached. At step 2, 20 patients will be randomized. They will receive at days 1 and 8 in a double cross design either oral CP-4126 at the recommended dose or gemcitabine 1000mg/m2 intravenously. At both steps, the schedule of treatment will be day 1, 8, 15 q4w until complete response or disease worsening/ progressing. All further treatment at step 2 will be oral CP-4126.

Detailed Description: This is a multicentre clinical study conducted in Belgium and in The Netherlands. The study is a phase I divided in 2 steps: The first step is a dose escalation to define the RD. At the second step the PK profile of oral CP-4126 will be compared with the PK profile of IV gemcitabine. In addition, the study is conducted to characterize the tolerability of oral CP-4126, to evaluate its bioavailability, and to make a preliminary assessment of antitumor activity in patients with solid tumours.