Phase Ib/II Study to Determine the Recommended Dose, Safety, and Preliminary Efficacy of Belinostat When Used in Combination With Carboplatin, Paclitaxel, and Bevacizumab in Patients With Untreated Non-small Cell Lung Cancer.
This is a Phase Ib/II, single center, open label, dose-finding study to evaluate the use of
Belinostat when given with standard of care chemotherapy in patients with untreated,
non-small cell lung cancer (NSCLC). In the Phase Ib portion, dose limiting toxicity
evaluation will be used to determine the maximum tolerated dose (MTD) of Belinostat when
given with fixed doses of bevacizumab, carboplatin, and paclitaxel(a BelCap-B regimen).
Three dose levels of Belinostat are proposed (600mg/kg, 800mg/kg, 1000mg/kg). Determination
of MTD will be the basis for establishing set dosing for the phase II component of the
The phase II portion of the study includes further drug safety evaluation and a preliminary
assessment of efficacy of Belinostat when used with specified induction and maintenance
regimens. Response will be evaluated through the RECIST criteria. Additional analysis will
be done to estimate the time to response, progression free survival, median survival, and
overall survival (OS) in study participants to 2 years post-initiation of cycle 1.
Based on a standard 3 x 3 statistical design, the phase Ib portion may accrue between 3 to
12 participants. Phase II will have a minimum sample size of 10 and a maximum of 16
patients. Participants who complete the Phase I portion and are able to advance to Phase
II, will be evaluable for the Phase II objectives.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
The recommended phase II dose of Belinostat when used in combination with carboplatin, paclitaxel and bevacizumab.
The aim of the initial phase Ib component is to establish the maximum tolerated dose (MTD) of Belinostat when used with a standard of care carboplatin, paclitaxel and bevacizumab course of therapy ("BelCap-B") regimen. The MTD will be determined through the process of dose-limiting-toxicity evaluation.
Martin E Guiterrez, MD
Holy Cross Hospital
United States: Food and Drug Administration
|Holy Cross Hospital, Inc||Fort Lauderdale, Florida 33308|