Study of the Combination of BKM120 and Cisplatin or Carboplatin in Patients With Advanced Solid Tumors
Status:
Completed
Trial end date:
2017-12-31
Target enrollment:
Participant gender:
Summary
PI3K signaling is a hallmark of many cancers. Subsets of cancers become dependent on PI3K
pathway signaling as a result of mutations of the PIK3CA gene itself or of regulators of PI3K
(e.g. PTEN, HER2). As a consequence, pathway mutated tumors are particularly sensitive
towards PI3K-pathway inhibition. BKM120 is a potent and highly specific oral pan-class I
PI3K-inhibitor.
The study FM-11-F01b is a phase Ib single institution study using the combination of BKM120
and cisplatin or carboplatin in patient with pathologically confirmed recurrent or metastatic
advanced solid tumor, for which treatment with a platinum agent is indicated (preferentially
head and neck, NSCLC, ovary, endometrial).
The primary objective of the study is to define the phase II recommended dose of daily oral
BKM120 and cisplatin (Group 1) or carboplatin (Group 2), given intravenously (IV) on day 1
every 3 weeks.