Trial Ruxolitinib and Peg-interferon Alpha-2a Combination in Patients With Primary Myelofibrosis RUXOPeg

Summary

Participation Requirements

Description

Part 1 is a dose finding phase 1 trial that assesses the safety of the combination of different doses of both ruxolitinib and peg-IFN alpha-2a Part 2 is a phase 2 randomized evaluation of the optimal doses found in the first part of the study to a total maximal number of 42 evaluable patients. It wi...

Part 1 is a dose finding phase 1 trial that assesses the safety of the combination of different doses of both ruxolitinib and peg-IFN alpha-2a Part 2 is a phase 2 randomized evaluation of the optimal doses found in the first part of the study to a total maximal number of 42 evaluable patients. It will use the Bayesian Phase 1/2 adaptively randomized design proposed by Yuan and Yin (2011) for combined drugs.The trial will examine three doses of ruxolitinib: 10, 15 and 20 mg BID and three doses of the peg-IFN alpha-2a: 45, 90, and 135 mcg/week). The starting doses for each drug have been selected based on prior monotherapy experience where these doses have shown some degree of clinical activity as single agents and pharmacodynamic data supports the activity observed. In the interest of patient safety, both of these compounds will start at dose levels at or near 50% of their respective maximum tolerated doses.

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