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Safety Study to Determine the Maximum Tolerated Dose, Pharmacokinetics and Pharmacodynamics of Oral MP470, a Multitargeted Tyrosine Kinase Inhibitor, in Patients With Solid Malignancies

Solid Tumors Clinical Trial

Official title:
Safety Study to Determine the Maximum Tolerated Dose, Pharmacokinetics and Pharmacodynamics of Oral MP470, a Multitargeted Tyrosine Kinase Inhibitor, in Patients With Solid Malignancies

Clinical Trial Summary

Multicenter, open-label, dose-ranging study in two parts: maximum tolerated dose (MTD) segment (the first 28-day course of MP 470) followed by long-term safety segment.

MTD segment: follows standard oncology phase-I design; within-patient dose level adjustments prohibited; each patient participates in one of three stages:

1. Accelerated Titration Stage

2. Dose Escalation/De-Escalation Stage

3. Dose Confirmation Stage

Clinical Trial Description

Multicenter, open-label, dose-ranging study in two parts: MTD Segment (the first 28-day course of MP 470) followed by Long-Term Safety Segment

MTD Segment: follows standard oncology phase-I design; within-patient dose level adjustments prohibited; each patient participates in one of three stages:

Accelerated Titration Stage: 1 patient per dose level; first patient receives MP 470 at 100 mg/day; subsequent patients assigned higher dose levels based on modified Fibonacci sequence; stage stops when any first-course DLT is observed or when grade-2 or greater MP 470-related toxicity is observed at 2 dose levels; dosing next patient prohibited until previous patient's MTD-Segment result is confirmed Dose Escalation/De-Escalation Stage: 3 patients per cohort; two additional patients enrolled to receive last dose level studied during Accelerated Titration Stage (first 3-patient cohort); subsequent 3-patient cohorts assigned dose level conditional on number of patients with first-course DLT in previous cohort; new cohorts enrolled until MTD is defined; dosing next cohort prohibited until previous cohort's MTD-Segment results are confirmed Dose Confirmation Stage: an additional 6-10 patients enrolled to receive MP 470 at the established MTD; patient accrual stops following Dose Confirmation Long-Term Safety Segment: patients continue receiving 28-day courses of MP 470 until experiencing unmanageable toxicity or disease progression; within-patient dose level adjustments based on toxicity; DLT during preceding 28-day course mandates one-level dose reduction; one-level dose increase possible in absence of grade-3 or greater MP 470-related AEs during preceding 28-day course ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00894894
Study type Interventional
Source Astex Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 1
Start date May 2007
Completion date December 2008
View Details
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