Clinical trial NCT00806286: Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer
Official title: Phase 2 Randomized Study of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-Naïve Subjects With Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Non-small Cell Lung Cancer
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-12-10
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: 18 weeks postdose
measure: 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
timeFrame: 18 weeks postdose
Secondary outcomes:
measure: 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
timeFrame: Baseline to date of death, up to approximately 2 years postdose
measure: 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
timeFrame: Baseline to disease progression, death, or withdrawal from study, up to approximately 2 years postdose
measure: 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
timeFrame: Baseline up to approximately 2 years postdose
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University Colorado Cancer Center
state: Colorado
city: Washington
country: United States
facility: Georgetown Univ. Medical Center
state: District of Columbia
city: Centralia
country: United States
facility: Southern Illinois Hematology/Oncology
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: South Bend
country: United States
facility: Michiana Hematology-Oncology
state: Indiana
city: Baltimore
country: United States
facility: Harbor View Cancer Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Middletown
country: United States
facility: Signal Point Clinical Research Center
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton Hershey Cancer Center
state: Pennsylvania
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Bangalore
country: India
facility: Kidwai Memorial Institute of Oncology
state: Karnataka
city: Aundh
country: India
facility: Pentagon Research
state: Maharashtra
city: Nashik
country: India
facility: Shatabdi Super Specialty Hospital
state: Mumbai Naka
city: Gujarat
country: India
facility: Hemato-Oncology Clinic, Vedanta
state: Navrangpura, Ahmedabad
city: Madurai
country: India
facility: Meenakshi Mission Hospital
state: Tamil Nadu
city: Kolkata
country: India
facility: Orchid Nursing Home
state: West Bengal
city: Chennai
country: India
facility: Apollo Specialty Hospital
city: Pune
country: India
facility: Ruby Hall Clinic
city: Pune
country: India
facility: Noble Hospital
city: Olsztyn
country: Poland
facility: Oddzial Chemioterapii ZOZ MSWiA
city: Poznan
country: Poland
facility: Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
city: Szczecin
country: Poland
facility: Specjalistyczny Szpital im. Prof. Alfresa Sokolowskiego
city: Timisoara
country: Romania
facility: Oncomed SRL
state: Judet Timis
city: Ploiesti
country: Romania
facility: Spitalul Municipal Ploiesti
state: Prahova
city: Bucuresti
country: Romania
facility: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuta
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuta
city: Iasi
country: Romania
facility: Centrul de Oncologie Medicala
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: