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
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
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
;
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