A clinical trial to study the effects of carboplatin / Paclitaxel and a new drug, CS- 7017, in patients with Non-Small Cell Lung Cancer

Phase 2

Completed

Registration Number: CTRI/2010/091/000491

Lead Sponsor: Daiichi Sankyo Pharma Development399 Thornall StreetEdison, NJUSA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 115

Inclusion Criteria

1) Histologically or cytologically confirmed metastatic (stage IV) NSCLC with no significant pleural effusion or pleural involvement from the tumor
2) Age greater than or equal to 18 years (<65 years in India)
3) Adequate organ and bone marrow function
4) Measurable disease based on RECIST criteria
5) ECOG performance status ≦ 1

Exclusion Criteria

1) Any prior systemic therapy for NSCLC
2) Major surgical procedure or other investigational agents within 4 weeks before study enrollment
3) Need for concomitant use of other thiazolidinediones during the study
4) History of any of the following conditions within 6 months prior to initiating study treatment: Diabetes mellitus requiring treatment with insulin or sulfonylureas or TZDs agents; Myocardial infarction with significant impairment of cardiac function; severe unstable angina pectoris; coronary/peripheral artery bypass graft; NYHA class III or IV congestive hart failure; malabsorption syndrome, chronic diarrhea, inflammatory bowel disease or partial bowel obstruction
5) Clinically active brain metastases, uncontrolled seizure disorder; spinal cord compression or carcinomatous meningitis
6) Periocardial or pleural effusion (e.g. requiring drainage) or pericardial involvement with the tumor

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) at 18 weeks for subjects with metastatic NSCLC who are treated with carboplatin and paclitaxel in combination with CS-7017 (Treatment Group 1) or matching placebo (Treatment Group 2).Timepoint: PFS rate at 18 weeks

Secondary Outcome Measures

Name	Time	Method
1)Median PFS <br>2) Objective response rate (ORR) (ie, the sum of the complete response [CR] and partial response [PR] rates)<br>3) Median and overall survival (OS)<br>4) Population PK of CS-7017<br>5) Safety and tolerability of CS-7017 administered in combination with carboplatin and paclitaxel<br>Timepoint: End of study