Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00806286
- Lead Sponsor
- Daiichi Sankyo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paclitaxel and Carboplatin Carboplatin - CS-7017 with Paclitaxel and Carboplatin Paclitaxel - CS-7017 with Paclitaxel and Carboplatin Carboplatin - Paclitaxel and Carboplatin Placebo Tablets - CS-7017 with Paclitaxel and Carboplatin CS7017 tablets - Paclitaxel and Carboplatin Paclitaxel -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Progression-Free Survival Based on Radiologic and Clinical Assessments and Death After Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer 18 weeks postdose Progression-free survival (PFS) was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (based upon radiographic tumor assessments) or death. Disease progression was determined in accordance with the RECIST version 1.0 criteria.
Percentage of Participants With Progression-Free Survival at 18 Weeks Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer 18 weeks postdose Progression-free survival (PFS) was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (based upon radiographic tumor assessments) or death. As per Response Evaluation Criteria for Solid Tumors v1.0, disease progression was characterized as confirmed complete response (CR) defined as disappearance of all target lesions, confirmed partial response (PR) defined as ≥30% decrease from baseline, stable disease (SD) defined as neither progressive disease (PD) nor PR, and PD defined as ≥20% increase from smallest sum of longest diameter recorded since treatment started.
- Secondary Outcome Measures
Name Time Method Number of Participants With Best Overall Tumor Response and Objective Response Rate Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Baseline to disease progression, death, or withdrawal from study, up to approximately 2 years postdose As per Response Evaluation Criteria for Solid Tumors v1.0, the best overall response was characterized as confirmed complete response (CR) defined as disappearance of all target lesions, confirmed partial response (PR) defined as ≥30% decrease from baseline, stable disease (SD) defined as neither progressive disease (PD) nor PR, and PD defined as ≥20% increase from smallest sum of longest diameter recorded since treatment started. Objective response rate (ORR) was defined as CR + PR.
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Baseline up to approximately 2 years postdose Summary of Kaplan-Meier Analysis of Overall Survival Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Baseline to date of death, up to approximately 2 years postdose Overall survival (OS) is defined as the time from randomization to the date of death resulting from any cause.
Trial Locations
- Locations (27)
Michiana Hematology-Oncology
🇺🇸South Bend, Indiana, United States
Southern Illinois Hematology/Oncology
🇺🇸Centralia, Illinois, United States
Signal Point Clinical Research Center
🇺🇸Middletown, Ohio, United States
Penn State Milton Hershey Cancer Center
🇺🇸Hershey, Pennsylvania, United States
Kidwai Memorial Institute of Oncology
🇮🇳Bangalore, Karnataka, India
Meenakshi Mission Hospital
🇮🇳Madurai, Tamil Nadu, India
Pentagon Research
🇮🇳Aundh, Maharashtra, India
Noble Hospital
🇮🇳Pune, India
Oddzial Chemioterapii ZOZ MSWiA
🇵🇱Olsztyn, Poland
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu
🇷🇴Bucuresti, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta
🇷🇴Cluj-Napoca, Romania
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
Apollo Specialty Hospital
🇮🇳Chennai, India
Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
🇵🇱Poznan, Poland
Harbor View Cancer Center
🇺🇸Baltimore, Maryland, United States
Specjalistyczny Szpital im. Prof. Alfresa Sokolowskiego
🇵🇱Szczecin, Poland
Oncomed SRL
🇷🇴Timisoara, Judet Timis, Romania
Spitalul Municipal Ploiesti
🇷🇴Ploiesti, Prahova, Romania
Centrul de Oncologie Medicala
🇷🇴Iasi, Romania
University Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Shatabdi Super Specialty Hospital
🇮🇳Nashik, Mumbai Naka, India
Hemato-Oncology Clinic, Vedanta
🇮🇳Gujarat, Navrangpura, Ahmedabad, India
Georgetown Univ. Medical Center
🇺🇸Washington, District of Columbia, United States
Orchid Nursing Home
🇮🇳Kolkata, West Bengal, India
Ruby Hall Clinic
🇮🇳Pune, India