Unknown

Dataset Information

0

A phase 1b/2 study of vosaroxin in combination with cytarabine in patients with relapsed or refractory acute myeloid leukemia.


ABSTRACT: Vosaroxin is a first-in-class anticancer quinolone derivative that intercalates DNA and inhibits topoisomerase II. This study assessed the safety and tolerability of vosaroxin plus cytarabine in patients with relapsed/refractory acute myeloid leukemia. Escalating vosaroxin doses (10-minute infusion; 10-90 mg/m(2); days 1, 4) were given in combination with cytarabine on one of two schedules: schedule A (24-hour continuous intravenous infusion, 400 mg/m(2)/day, days 1-5) or schedule B (2-hour intravenous infusion, 1 g/m(2)/day, days 1-5). Following dose escalation, enrollment was expanded at the maximum tolerated dose. Of 110 patients enrolled, 108 received treatment. The maximum tolerated dose of vosaroxin was 80 mg/m(2) for schedule A (dose-limiting toxicities: grade 3 bowel obstruction and stomatitis) and was not reached for schedule B (recommended phase 2 dose: 90 mg/m(2)). In the efficacy population (all patients in first relapse or with primary refractory disease treated with vosaroxin 80-90 mg/m(2); n=69), the complete remission rate was 25% and the complete remission/complete remission with incomplete blood count recovery rate was 28%. The 30-day all-cause mortality rate was 2.5% among all patients treated at a dose of 80-90 mg/m(2). Based upon these results, a phase 3 trial of vosaroxin plus cytarabine was initiated in patients with relapsed/refractory acute myeloid leukemia. (Clinicaltrials.gov identifier: NCT00541866).

SUBMITTER: Lancet JE 

PROVIDER: S-EPMC4803139 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

altmetric image

Publications

A phase 1b/2 study of vosaroxin in combination with cytarabine in patients with relapsed or refractory acute myeloid leukemia.

Lancet Jeffrey E JE   Roboz Gail J GJ   Cripe Larry D LD   Michelson Glenn C GC   Fox Judith A JA   Leavitt Richard D RD   Chen Tianling T   Hawtin Rachael R   Craig Adam R AR   Ravandi Farhad F   Maris Michael B MB   Stuart Robert K RK   Karp Judith E JE  

Haematologica 20141107 2


Vosaroxin is a first-in-class anticancer quinolone derivative that intercalates DNA and inhibits topoisomerase II. This study assessed the safety and tolerability of vosaroxin plus cytarabine in patients with relapsed/refractory acute myeloid leukemia. Escalating vosaroxin doses (10-minute infusion; 10-90 mg/m(2); days 1, 4) were given in combination with cytarabine on one of two schedules: schedule A (24-hour continuous intravenous infusion, 400 mg/m(2)/day, days 1-5) or schedule B (2-hour intr  ...[more]

Similar Datasets

| S-EPMC7016810 | biostudies-literature
| S-EPMC8580622 | biostudies-literature
| S-EPMC4822512 | biostudies-literature
| S-EPMC5932089 | biostudies-literature
| S-EPMC6167965 | biostudies-literature
| S-EPMC6119144 | biostudies-literature
| S-EPMC9327534 | biostudies-literature
| S-EPMC7289527 | biostudies-literature
| S-EPMC6616264 | biostudies-literature