Phase I clinical trial of the base excision repair inhibitor methoxyamine in combination with fludarabine for patients with advanced hematologic malignancies.

ABSTRACT:

Purpose

We determined the safety, pharmacokinetics, pharmacodynamics and recommended phase II dose of the base excision repair blocker methoxyamine combined with fludarabine.

Materials and methods

This was a phase I study with intravenous fludarabine (25 mg/m², days 1-5), and methoxyamine (15 mg/m²-120 mg/m², once). A maximum of six cycles were given. Adult patients with relapsed/refractory hematologic malignancies, excluding acute myeloid leukemia, were eligible.

Results

Twenty patients were treated; diagnoses included CLL/SLL (n = 10), follicular lymphoma (n = 3), DLBCL (n = 3), mantle cell lymphoma (n = 1), anaplastic large cell lymphoma (n = 1) and plasma cell myeloma (n = 2). No DLTs were

SUBMITTER: Caimi PF 

PROVIDER: S-EPMC5668101 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature