Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Metastatic Non-small Cell Lung Cancer

Treatments: Drug: Paclitaxel; Drug: Placebo Tablets; Drug: CS7017 tablets; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00806286

CS7017-A-U202

Details and patient eligibility

About

The study has a safety and a Phase 2 portion. In the safety portion of the study, subjects with metastatic non-small cell lung cancer will be treated with study drug (CS-7017) in combination with carboplatin and paclitaxel to evaluate safety. In the Phase 2 portion of the study, subjects will receive study drug (CS-7017) or placebo in combination with carboplatin and paclitaxel to evaluate effectiveness and safety. The study will find out if adding CS-7017 to carboplatin and paclitaxel will be safe and improve progression free survival in subjects with metastatic non-small cell lung cancer.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed metastatic (stage IV) NSCLC with no significant pleural effusion or pleural involvement from the tumor
• Age greater than or equal to 18 years
• Adequate organ and bone marrow function

Exclusion criteria

• Any prior systemic therapy for NSCLC
• Major surgical procedure or other investigational agents within 4 weeks before study enrollment
• Need for concomitant use of other thiazolidinediones during the study
• History of any of the following conditions within 6 months prior to initiating study treatment: Diabetes mellitus requiring treatment with insulin or sulfonylureas or thiazolidinediones (TZDs) agents; Myocardia infarction with significant impairment of cardia function; Malabsorption syndrome, chronic diarrhea, inflammatory bowel disease or partial bowel obstruction;
• Clinically active brain metastases, uncontrolled seizure disorder; spinal cord compression or carcinomatous meningitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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111 participants in 2 patient groups, including a placebo group

CS-7017 with Paclitaxel and Carboplatin

Experimental group

Treatment:

Drug: CS7017 tablets

Drug: Carboplatin

Drug: Paclitaxel

Paclitaxel and Carboplatin

Placebo Comparator group

Treatment:

Drug: Placebo Tablets

Drug: Carboplatin

Drug: Paclitaxel