Conditions: Non-small-cell Lung Cancer
Keywords: Cancer Lung Cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 28
Healthy volunteers: no

Brief summary:
The purpose of this study is to determined the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered continually twice daily in combination with carboplatin and paclitaxel to patients with advanced or metastatic non-small cell lung cancer.

Detailed description:

Arms:
arm 1: This will be a dose-escalation evaluation of 12-18 participants to determine the maximum tolerated dose of E7080 in combination with paclitaxel and carboplatin. arm 2: Dosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort.

Interventions: intervention 1: E7080 intervention 2: E7080 intervention 3: Paclitaxel intervention 4: Carboplatin
Intervention descriptions: intervention 1: Drug: E7080 will be administered orally starting at a dose of 6 mg twice daily during the 7-day run-in period and for 3 weeks (Cycle 1). intervention 2: Maximum tolerated dose determined in the Dose-Escalation Cohort will be administered to the Expansion Cohort. After E7080 is taken on Day 1, paclitaxel (200 mg/m2) will be administered intravenously (IV), followed by IV carboplatin (AUC 6.0 min/mg/mL). intervention 3: Paclitaxel (200 mg/m2) will be administered intravenously (IV) on Day 1 after administration of E7080. intervention 4: Carboplatin (AUC 6.0 min/mg/mL) will be administered IV on Day 1 after administration of E7080 and Paclitaxel.

Protocol document: