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

NCT00806286 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2020-05-13

Study results available
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Summary

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.

Conditions

  • Metastatic Non-small Cell Lung Cancer

Interventions

DRUG

CS7017 tablets

CS7017 tablets, strength 0.25 mg, two tablets, two times daily for twenty-five to thirty months

DRUG

Paclitaxel

Intravenous (IV), 200 mg/m\^2, once every three weeks for up to 18 weeks

DRUG

Carboplatin

IV, area under the curve (AUC) of 6, once every three weeks for up to 18 weeks

DRUG

Placebo Tablets

Placebo tablets matching CS-7017 tablets

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2012-01-31
Completion
2012-08-31

Countries

  • United States
  • India
  • Poland
  • Romania

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00806286 on ClinicalTrials.gov