Dataset Information

A Phase I trial of talazoparib in patients with advanced hematologic malignancies.

ABSTRACT:

Aim

The objective of this study was to establish the maximum tolerated dose (MTD), safety, pharmacokinetics, and anti-leukemic activity of talazoparib.

Patients & methods

This Phase I, two-cohort, dose-escalation trial evaluated talazoparib monotherapy in advanced hematologic malignancies (cohort 1: acute myeloid leukemia/myelodysplastic syndrome; cohort 2: chronic lymphocytic leukemia/mantle cell lymphoma).

Results

Thirty-three (cohort 1: n = 25; cohort 2: n = 8) patients received talazoparib (0.1-2.0 mg once daily). The MTD was exceeded at 2.0 mg/day in cohort 1 and at 0.9 mg/day in cohort 2. Grade ≥3 adverse events were primarily hematologic. Eighteen (54.5%) patients reported stable disease.

Conclusion

Talazoparib is relatively well tolerated in hematologic malignancies, with a similar MTD as in solid tumors, and shows preliminary anti leukemic activity.Clinical trial registration: NCT01399840 (ClinicalTrials.gov).

SUBMITTER: Gopal AK

PROVIDER: S-EPMC8609999 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature

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Publications

A Phase I trial of talazoparib in patients with advanced hematologic malignancies.

Gopal Ajay K AK Popat Rakesh R Mattison Ryan J RJ Menne Tobias T Bloor Adrian A Gaymes Terry T Khwaja Asim A Juckett Mark M Chen Ying Y Cotter Matthew J MJ Mufti Ghulam J GJ

International journal of hematologic oncology 20210901 3

<h4>Aim</h4>The objective of this study was to establish the maximum tolerated dose (MTD), safety, pharmacokinetics, and anti-leukemic activity of talazoparib.<h4>Patients & methods</h4>This Phase I, two-cohort, dose-escalation trial evaluated talazoparib monotherapy in advanced hematologic malignancies (cohort 1: acute myeloid leukemia/myelodysplastic syndrome; cohort 2: chronic lymphocytic leukemia/mantle cell lymphoma).<h4>Results</h4>Thirty-three (cohort 1: n = 25; cohort 2: n = 8) patients ...[more]

PMID: 34840720

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Dataset Information

A Phase I trial of talazoparib in patients with advanced hematologic malignancies.

Aim

Patients & methods

Results

Conclusion

Publications

A Phase I trial of talazoparib in patients with advanced hematologic malignancies.

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