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Lung Cancer. 2017 Feb;104:126-130. doi: 10.1016/j.lungcan.2016.12.019. Epub 2016 Dec 30.

An open-label, phase II study of the polo-like kinase-1 (Plk-1) inhibitor, BI 2536, in patients with relapsed small cell lung cancer (SCLC).

Author information

1
Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
2
Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada.
3
Cancer Centers of the Carolinas, Greenville, SC, USA.
4
Washington University School of Medicine, St. Louis, MO, USA.
5
Highlands Oncology Group, Fayetteville, AR, USA.
6
Rush University Medical Center, Chicago, IL, USA.
7
Charleston Hematology Oncology Associates, Charleston, SC, USA.
8
Seattle Cancer Care Alliance, Seattle, WA, USA.
9
Boehringer Ingelheim, Biberach, Germany.
10
Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA. Electronic address: bruce_johnson@dfci.harvard.edu.
11
University of Pittsburgh, Pittsburgh, PA, USA.

Abstract

OBJECTIVES:

This phase II, open-label study was designed to evaluate the response rate to the polo-like kinase 1 (Plk-1) inhibitor BI 2536 in patients with sensitive-relapsed small cell lung cancer (SCLC). Secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response, and safety.

MATERIALS AND METHODS:

Patients were treated with the recommended phase II dose of 200mg of BI 2536 intravenously every 21days. This was a two-stage design with an early stopping rule in place if responses were not seen in at least 2 of the first 18 enrolled patients.

RESULTS AND CONCLUSION:

Twenty-three patients were enrolled in the study and 21 patients were evaluable for response. No responses were observed and all 23 patients have progressed. The median PFS was 1.4 months. Treatment was generally well tolerated and the most frequent adverse events were neutropenia, fatigue, nausea, vomiting, and constipation. BI 2536 is not effective in the treatment of sensitive relapsed SCLC. The criteria for expanding the trial to the second stage were not achieved, and the study was terminated for a lack of efficacy.

KEYWORDS:

BI 2536; Plk-1 inhibition; Polo-like kinase; Small cell lung cancer

PMID:
28212994
DOI:
10.1016/j.lungcan.2016.12.019
[Indexed for MEDLINE]

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