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

NCT ID: NCT00806286

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2012-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CS-7017 with Paclitaxel and Carboplatin

Group Type: EXPERIMENTAL

CS7017 tablets

Intervention Type: DRUG

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

Paclitaxel

Intervention Type: DRUG

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

Carboplatin

Intervention Type: DRUG

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

Paclitaxel and Carboplatin

Group Type: PLACEBO_COMPARATOR

Paclitaxel

Intervention Type: DRUG

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

Carboplatin

Intervention Type: DRUG

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

Placebo Tablets

Intervention Type: DRUG

Placebo tablets matching CS-7017 tablets

Interventions

CS7017 tablets

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

Intervention Type: DRUG

Paclitaxel

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

Intervention Type: DRUG

Carboplatin

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

Intervention Type: DRUG

Placebo Tablets

Placebo tablets matching CS-7017 tablets

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

University Colorado Cancer Center

Aurora, Colorado, United States

Georgetown Univ. Medical Center

Washington D.C., District of Columbia, United States

Southern Illinois Hematology/Oncology

Centralia, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Michiana Hematology-Oncology

South Bend, Indiana, United States

Harbor View Cancer Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Signal Point Clinical Research Center

Middletown, Ohio, United States

Penn State Milton Hershey Cancer Center

Hershey, Pennsylvania, United States

Eastern Virginia Medical School

Norfolk, Virginia, United States

Kidwai Memorial Institute of Oncology

Bangalore, Karnataka, India

Pentagon Research

Aundh, Maharashtra, India

Shatabdi Super Specialty Hospital

Nashik, Mumbai Naka, India

Hemato-Oncology Clinic, Vedanta

Gujarat, Navrangpura, Ahmedabad, India

Meenakshi Mission Hospital

Madurai, Tamil Nadu, India

Orchid Nursing Home

Kolkata, West Bengal, India

Apollo Specialty Hospital

Chennai, , India

Ruby Hall Clinic

Pune, , India

Noble Hospital

Pune, , India

Oddzial Chemioterapii ZOZ MSWiA

Olsztyn, , Poland

Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii

Poznan, , Poland

Specjalistyczny Szpital im. Prof. Alfresa Sokolowskiego

Szczecin, , Poland

Oncomed SRL

Timișoara, Judet Timis, Romania

Spitalul Municipal Ploiesti

Ploieşti, Prahova, Romania

Institutul Oncologic Prof. Dr. Alexandru Trestioreanu

Bucharest, , Romania

Institutul Oncologic Prof. Dr. Ion Chiricuta

Cluj-Napoca, , Romania

Institutul Oncologic Prof. Dr. Ion Chiricuta

Cluj-Napoca, , Romania

Centrul de Oncologie Medicala

Iași, , Romania

Countries

United States; India; Poland; Romania

Other Identifiers

CS7017-A-U202

Identifier Type: -

Identifier Source: org_study_id