Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: PPAR gamma agonist Tumor Cancer Antineoplastic Agent Respiratory Tract Neoplasms Carboplatin Paclitaxel Neoplasms
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 16
Healthy volunteers: no

Brief summary:
The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with carboplatin and paclitaxel, and to assess the pharmacokinetics of CS-7017 in combination with carboplatin and paclitaxel.

Detailed description:

Arms:
arm 1: Drug: CS-7017 from 0.25 mg twice a day (BID) to 0.50 mg BID for up to 4\~6 cycles (1 cycle: 3 weeks)

Drug: Carboplatin IV, Area under the curve (AUC) of 6 mg/mL\*min, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks)

Drug: Paclitaxel IV, 200mg/m\^2, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks)

Interventions: intervention 1: CS-7017 intervention 2: Carboplatin intervention 3: Paclitaxel
Intervention descriptions: intervention 1: Drug: CS-7017 from 0.25 mg BID to 0.50 mg BID for up to 4\~6 cycles (1 cycle: 3 weeks) intervention 2: Drug: Carboplatin IV, AUC of 6 mg/mL\*min, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks) intervention 3: Drug: Paclitaxel IV, 200mg/m\^2, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks)

Protocol document: