Advanced Solid Tumors Clinical Trial
Official title:
A Phase I Study of BKM120 With mFOLFOX6 in Patients With Advanced Solid Tumors With Expansion Cohort in Metastatic Pancreatic Cancers.
The purpose of this study is to establish the safety and tolerability of BKM120 when combined with mFOLFOX6 and to define the maximum tolerated dose of BKM120 in this combination in advanced solid tumors including metastatic pancreatic cancer.
This single arm, multicenter, open-label Phase I clinical trial has been designed to
establish the safety and tolerability of dose escalating BKM120 when combined with mFOLFOX6
and to define the MTD of BKM120 in this combination. Secondary objective will be to estimate
the response rate, Progression Free Survival rate, and Overall Survival rate, after
treatment with the Maximum Tolerated Dose of BKM120 in combination with mFOLFOX6 in patients
with advanced solid tumors and metastatic pancreatic cancer. Eligible patients will be
treated with BKM120 orally (PO), once per day (QD) in combination with mFOLFOX6 administered
intravenously (IV) every 2 weeks on Days 1 and 15 of each cycle using a standard 3+3 dose
escalation scheme. Each cycle will be repeated every 4 weeks (28 days). FOLFOX6 treatment
will be as follows: Oxaliplatin: 85 mg/m2 IV, Leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2
IV and 5FU infusion: 2400 mg/m2 IV.
In the absence of treatment delays due to adverse events (AEs), treatment may continue
until: disease progression, intercurrent illness that prevents further administration of
treatment, unacceptable AE(s), patient decides to withdraw from the study, or general or
specific changes in the patient's condition render the patient unacceptable for further
treatment in the judgment of the investigator.
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|---|---|---|---|
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