drugset / Trial / NCT01884922

Study Of Vinblastine in Combination With Nilotinib in Children, Adolescents and Young Adults

NCT01884922

Phase 1 Completed 35 enrolled Gustave Roussy, Cancer Campus, Grand Paris
NaSingle-groupOpen-labelTreatment

Summary

Multicenter, open label, prospective study including successively a phase I trial and then a phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both drugs, vinblastine and nilotinib.

Timeline

Start
2013-05-29
Primary completion
2015-09-02
Completion
2016-04-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Nilotinib Small molecule 115 mg/m2 Oral
Subject Nilotinib Small molecule 230 mg/m2 Oral
Subject Nilotinib Small molecule 350 mg/m2 Oral
Subject Vinblastine Small molecule 3 mg/m2 Other
Subject Vinblastine Small molecule 6 mg/m2 Other

Indications