Safety Study to Determine the Maximum Tolerated Dose, Pharmacokinetics and Pharmacodynamics of Oral MP470, a Multitargeted Tyrosine Kinase Inhibitor, in Patients With Solid Malignancies
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
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability
6 months
No
United States: Food and Drug Administration
SGI-0470-01
NCT00894894
May 2007
December 2008
Name | Location |
---|---|
Translation Genomics Research Institute (TGen)/Scottsdale Clin.Researc | Scottsdale, Arizona 85258 |
So. Texas Accelerated Research Therapeutics-START | San Antonio, Texas 78229 |