NDLI: A phase II, single-arm, open-label, multicenter study to evaluate the efficacy and safety of P276-00, a cyclin-dependent kinase inhibitor, in patients with relapsed or refractory mantle cell lymphoma.

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A phase II, single-arm, open-label, multicenter study to evaluate the efficacy and safety of P276-00, a cyclin-dependent kinase inhibitor, in patients with relapsed or refractory mantle cell lymphoma.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Cassaday, Ryan D. Goy, Andre Advani, Suresh Chawla, Purvi Nachankar, Rajesh Gandhi, Mansi Gopal, Ajay K.
Description	Author Affiliation: Cassaday RD ( Department of Medicine, University of Washington School of Medicine, and Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.); Goy A ( John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ.); Advani S ( Jaslok Hospital and Research Centre, Mumbai, India.); Chawla P ( Piramal Enterprises Limited, Mumbai, India.); Nachankar R ( Piramal Enterprises Limited, Mumbai, India.); Gandhi M ( Piramal Enterprises Limited, Mumbai, India.); Gopal AK ( Department of Medicine, University of Washington School of Medicine, and Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA. Electronic address: agopal@uw.edu.)
Abstract	INTRODUCTION: Overexpression of cyclin D1 is a hallmark feature of mantle cell lymphoma (MCL). Many of the oncogenic effects of cyclin D1 are mediated through cyclin-dependent kinases (CDKs). P276-00 is a potent small molecule inhibitor of CDK4-D1, CDK1-B, and CDK9-T, with promising activity in preclinical models. In phase I studies of P276-00 in patients with refractory solid neoplasms, it was well-tolerated with a mild trend toward single-agent efficacy. PATIENTS AND METHODS: A phase II study of P276-00 was conducted in patients with relapsed or refractory MCL at the recommended dose of 185 mg/m(2)/day from days 1 to 5 of a 21-day cycle. Thirteen patients were enrolled in the present study. RESULTS: Of the 13 patients, 11 experienced disease progression, 1 patient was withdrawn because of an adverse event (AE), and 1 patient died. Also, 11 patients (84.6%) experienced a treatment-emergent AE deemed related to P276-00. Of the 13 patients, 9 (69.2%) received ≥ 2 cycles of treatment, which was the predefined threshold to be evaluable for efficacy. Treatment was discontinued early in 2 patients because of AEs (1 of which was attributed to P276-00 administration) and in 2 patients because of disease progression. Finally, 2 patients experienced stable disease for an estimated median duration of 60.5 days (range, 58-63 days). The estimated median time to progression for the predefined efficacy population was 43 days (range, 38-58 days). CONCLUSION: Given the results observed in the present study, if evaluation of CDK inhibition in MCL continues, it should be considered earlier in the disease course or as a part of combination strategies for relapsed or refractory disease.
File Format	HTM / HTML
ISSN	21522650
e-ISSN	21522669
DOI	10.1016/j.clml.2015.02.021
Journal	Clinical Lymphoma Myeloma and Leukemia
Issue Number	7
Volume Number	15
Language	English
Publisher	Elsevier
Publisher Date	2015-07-01
Publisher Place	United States
Access Restriction	Open
Subject Keyword	Discipline Oncology Cyclin-dependent Kinase Inhibitor Proteins Therapeutic Use Drug Resistance, Neoplasm Drug Effects Flavones Lymphoma, Mantle-cell Drug Therapy Neoplasm Recurrence, Local Cyclin D1 Adverse Effects Clinical Trial, Phase Ii Multicenter Study Research Support, N.i.h., Extramural Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Hematology Cancer Research Oncology

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