The Maximum Tolerated Dose and to Evaluate Safety and Efficacy of Belinostat (PXD-101) in Combination With Paclitaxel Plus Carboplatin in Chemotherapy-Naive Patients With Stage IV Non-Small-Cell Lung Cancer (NSCLC)
This is a Phase 1/2, multi-center, open label single arm study. Patients meeting all
inclusion and exclusion criteria will receive up to 6 cycles of combination therapy of
belinostat plus carboplatin (AUC 6) and paclitaxel 200 mg/m2.
During phase I the Maximum Tolerated Dose (MTD) of belinostat in combination with
carboplatin and paclitaxel will be determined in patients with Stage IV non-small cell lung
cancer who have received no prior systemic chemotherapy. The dose escalation study will be
conducted using traditional escalation rule of 3+3 design, during the first cycle of
therapy. Belinostat will be assessed at a starting dose level of 1000 mg/m2 and multiple
dose levels may be evaluated. Doses of belinostat, carboplatin and paclitaxel will remain
constant throughout the study, unless dose modification is required by toxicity. Treatment
is given on days 1-5 of every 21-day cycle. Routine safety evaluations will be conducted on
days, 1, 8, and 15 of every cycle. Tumor measurement will be done after every 2 cycles of
the treatment.
Additional 20 patients will be treated at the MTD defined dose during phase II expansion
portion of the study.
All patients will receive up to 6 cycles of combination therapy and be followed until
occurrence of unacceptable toxicity, disease progression, withdrawal of consent or death.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
24 Months
No
Brian Matthews, MD
Principal Investigator
Clearview Cancer Institute
United States: Food and Drug Administration
SPI-1014-Bel
NCT01310244
December 2010
December 2013
Name | Location |
---|---|
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Yale Cancer Center | New Haven, Connecticut 06520-8028 |
Tower Cancer Research Foundation | Beverly Hills, California 90211 |
Lakeland Regional Cancer Center | Lakeland, Florida 33805 |
California Pacific Medical Center | San Francisco, California 94115 |
Sarcoma Oncology Center | Santa Monica, California 90403 |
Clearview Cancer Institute (CCI) | Huntsville, Alabama 35805 |
University Cancer Insitute | Boynton Beach, Florida 33426 |