Solid Tumors Clinical Trial
Official title:
Phase Ib Study of the Combination of BKM120 and Cisplatin or Carboplatin in Patients With Advanced Solid Tumors
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.
Despite recent progresses in antineoplastic therapy durable cancer remission is still
infrequent in many solid tumors and new treatment options are needed for patients whose
cancer has progressed following standard therapies. There is an increasing interest of
evaluating new combinations of cytotoxics with new molecule targeted agents which could
increase antitumor activity.
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-inhibThe 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).
itor. The study treatment foreseen BKM120 administered on a continuous once daily dosing
schedule at a dose of 60, 80 or 100 mg (p.o.) plus Carboplatin or Cisplatin. Cisplatin 75
mg/mq will be administered as a 2 hours intravenous infusion every 3 weeks. Carboplatin AUC 5
(or AUC 6 if dose level 3 has been completed) will be administered as a 30 minutes
intravenous infusion diluted in 250 mL of normal saline every 3 weeks.
This is a single institution phase I study. Up to 3 dose levels of daily BMK120 will be
studied. A standard 3 + 3 phase I dose escalation design will be used for both Group 1 and
Group 2. Dose escalation in Group 1 and Group 2 will be mutually independent.
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. BKM120 and carboplatin or cisplatin.
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