Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
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)
To define Phase 1/2 Maximum Tolerated Dose Study 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.
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