drugset

drugset / Trial / NCT01411267

AC220 for Children With Relapsed/Refractory ALL or AML

NCT01411267 ↗

Phase 1 Completed 24 enrolled Therapeutic Advances in Childhood Leukemia Consortium Ambit Biosciences Corporation · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

This is a phase I study of the investigational drug AC220 combined with cytarabine and etoposide in pediatric patients with relapsed acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML).

Timeline

Start: 2011-09-01
Primary completion: 2013-09-12
Completion: 2013-09-12

Publications

Results Cooper TM, Cassar J, Eckroth E, Malvar J, Sposto R, Gaynon P, Chang BH, Gore L, August K, Pollard JA, DuBois SG, Silverman LB, Oesterheld J, Gammon G, Magoon D, Annesley C, Brown PA. A Phase I Study of Quizartinib Combined with Chemotherapy in Relapsed Childhood Leukemia: A Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) Study. Clin Cancer Res. 2016 Aug 15;22(16):4014-22. doi: 10.1158/1078-0432.CCR-15-1998. Epub 2016 Feb 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Quizartinib	Small molecule	25 mg/m2	Oral
Subject	Quizartinib	Small molecule	40 mg/m2	Oral
Subject	Quizartinib	Small molecule	60 mg/m2	Oral
Subject	Quizartinib	Small molecule	90 mg/m2	Oral
Subject	Quizartinib	Small molecule	130 mg/m2	Oral
Background	Cytarabine	Small molecule	20 mg	Intravenous
Background	Cytarabine	Small molecule	30 mg	Intravenous
Background	Cytarabine	Small molecule	50 mg	Intravenous
Background	Cytarabine	Small molecule	70 mg	Intravenous
Background	Cytarabine	Small molecule	1000 mg/m2	Intravenous
Background	Etoposide	Small molecule	150 mg/m2	Intravenous
Background	Methotrexate	Small molecule	6 mg	Intrathecal
Background	Methotrexate	Small molecule	8 mg	Intrathecal
Background	Methotrexate	Small molecule	10 mg	Intrathecal
Background	Methotrexate	Small molecule	12 mg	Intrathecal
Background	Methotrexate	Small molecule	15 mg	Intrathecal

Indications