Parallel phase Ib studies of two schedules of buparlisib (BKM120) plus carboplatin and paclitaxel (q21 days or q28 days) for ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2015-02-12

AUTHORS

David M. Hyman, Alexandra E. Snyder, Richard D. Carvajal, John F. Gerecitano, Martin H. Voss, Alan L. Ho, Jason Konner, Jennifer L. Winkelmann, Megan A. Stasi, Kelsey R. Monson, Alexia Iasonos, David R. Spriggs, Philip Bialer, Mario E. Lacouture, Jerrold B. Teitcher, Nora Katabi, Matthew G. Fury

ABSTRACT

PurposePhosphatidylinositol-3-kinase I (PI3K) inhibition sensitizes a wide range of cancer cell lines to platinum/taxane-based chemotherapy. This phase I study combines buparlisib, a pan-class 1A PI3K inhibitor, with two schedules of carboplatin and paclitaxel for patients with advanced solid tumors (ClinicalTrials.gov, NCT01297452).MethodsThere were two regimens: Group 1 received carboplatin AUC 5 and paclitaxel 175 mg/m2, on day 1 of a 21-day cycle with pegfilgrastim support; Group 2 received carboplatin AUC 5 (day 1) and paclitaxel 80 mg/m2 (days 1, 8, and 15) on a 28-day cycle without growth factor support. In both groups, three dose levels of buparlisib were explored: 50, 80, and 100 mg/day. Primary endpoint was to identify recommended phase II doses of buparlisib in both groups.ResultsThirty subjects enrolled, 16 in Group 1 and 14 in Group 2. The DLTs were elevated alkaline phosphatase (n = 1) and uncomplicated neutropenia (n = 2). The median numbers of cycles were 5 (Group 1) and 6 (Group 2). The MTDs for buparlisib were 100 mg/day in Group 1 and 80 mg/day in Group 2. Among 25 patients with measurable disease, the confirmed objective response rate was 20 % (one complete response, four partial responses). Among three patients with known loss of PTEN expression, all derived clinical benefit from treatment.ConclusionThe addition of buparlisib to carboplatin + paclitaxel was well tolerated, and preliminary activity was notable against tumors with loss of PTEN expression. More... »

PAGES

747-755

Journal

TITLE

Cancer Chemotherapy and Pharmacology

ISSUE

4

VOLUME

75

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00280-015-2693-z

DOI

http://dx.doi.org/10.1007/s00280-015-2693-z

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1044021272

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/25672916


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361 Dermatology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center (MSKCC), New York, NY, USA
362 Developmental Therapeutics Clinic and Head and Neck Service, Department of Medicine, Breast and Imaging Center, Memorial Sloan Kettering Cancer Center (MSKCC) and Weill Cornell Medical College, 300 East 66th Street, Room 1453, New York, NY, USA
363 Developmental Therapeutics Clinic, Department of Medicine, Memorial Sloan Kettering Cancer Center (MSKCC), 1275 York Avenue, New York, NY, USA
364 schema:name Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center (MSKCC), New York, NY, USA
365 Department of Pathology, Memorial Sloan Kettering Cancer Center (MSKCC), New York, NY, USA
366 Department of Psychiatry, Memorial Sloan Kettering Cancer Center (MSKCC), New York, NY, USA
367 Department of Radiology, Memorial Sloan Kettering Cancer Center (MSKCC), New York, NY, USA
368 Dermatology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center (MSKCC), New York, NY, USA
369 Developmental Therapeutics Clinic and Head and Neck Service, Department of Medicine, Breast and Imaging Center, Memorial Sloan Kettering Cancer Center (MSKCC) and Weill Cornell Medical College, 300 East 66th Street, Room 1453, New York, NY, USA
370 Developmental Therapeutics Clinic, Department of Medicine, Memorial Sloan Kettering Cancer Center (MSKCC), 1275 York Avenue, New York, NY, USA
371 rdf:type schema:Organization
 




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