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A randomised phase II trial of the Polo-like kinase inhibitor BI 2536 in chemo-naïve patients with unresectable exocrine adenocarcinoma of the pancreas – a study within the Central European Society Anticancer Drug Research (CESAR) collaborative network
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A randomised phase II trial of the Polo-like kinase inhibitor BI 2536 in chemo-naïve patients with unresectable exocrine adenocarcinoma of the pancreas – a study within the Central European Society Anticancer Drug Research (CESAR) collaborative network
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A randomised phase II trial of the Polo-like kinase inhibitor BI 2536 in chemo-naïve patients with unresectable exocrine adenocarcinoma of the pancreas – a study within the Central European Society Anticancer Drug Research (CESAR) collaborative network
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Journal Article
A randomised phase II trial of the Polo-like kinase inhibitor BI 2536 in chemo-naïve patients with unresectable exocrine adenocarcinoma of the pancreas – a study within the Central European Society Anticancer Drug Research (CESAR) collaborative network
2012
Overview
Background:
BI 2536, a novel Polo-like kinase 1 inhibitor, was assessed in patients with unresectable advanced exocrine adenocarcinoma of the pancreas.
Methods:
The study employed a two-stage design. Randomised first-line patients received BI 2536 200 mg on day 1 (
n
=43) or 60 mg on days 1–3 (
n
=43) every 21 days. Recruitment of second-line patients was planned for a second stage dependent on an interim analysis demonstrating ⩾2 responses in the first 18 evaluable patients following 12 weeks of treatment and/or tumour control ⩾12 weeks in 5 patients per schedule. Primary end point was objective response rate (ORR).
Results:
By independent review, ORR was 2.3% (all partial) and 24.4% had stable disease as confirmed best response. The second stage was not initiated. Median overall and progression-free survivals were 149 (95% confidence interval (CI), 91–307) and 46 days (95% CI, 44–56). Most common drug-related adverse events were neutropenia (37.2%), leukopenia (29.1%), fatigue (29.1%) and nausea (22.1%); most common grade 3/4-related events were neutropenia (36.0%), leukopenia (27.9%) and thrombocytopenia (8.1%).
Conclusion:
Given the low ORR and poor survival, further development of BI 2536 monotherapy is not warranted in this population.
Publisher
Nature Publishing Group UK,Nature Publishing Group
Subject
/ Adenocarcinoma - drug therapy
/ Aged
/ Biological and medical sciences
/ Biomedical and Life Sciences
/ Cell Cycle Proteins - antagonists & inhibitors
/ Cell Cycle Proteins - metabolism
/ Female
/ Gastroenterology. Liver. Pancreas. Abdomen
/ Humans
/ Kinases
/ Liver. Biliary tract. Portal circulation. Exocrine pancreas
/ Male
/ Oncology
/ Pancreatic Neoplasms - drug therapy
/ Pancreatic Neoplasms - enzymology
/ Pancreatic Neoplasms - metabolism
/ Protein Serine-Threonine Kinases - antagonists & inhibitors
/ Protein Serine-Threonine Kinases - metabolism
/ Proto-Oncogene Proteins - antagonists & inhibitors
/ Proto-Oncogene Proteins - metabolism
/ Pteridines - adverse effects
/ Pteridines - pharmacokinetics
/ Pteridines - therapeutic use
/ Tumors
