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Phase 2 Randomized Study of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-Naïve Subjects With Metastatic Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Non-small Cell Lung Cancer

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Trial Information

Phase 2 Randomized Study of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-Naïve Subjects With Metastatic Non-Small Cell Lung Cancer


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
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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) rate

Outcome Time Frame:

week 18

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

CS7017-A-U202

NCT ID:

NCT00806286

Start Date:

December 2008

Completion Date:

August 2012

Related Keywords:

  • Metastatic Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Rush University Medical CenterChicago, Illinois  60612-3824
Eastern Virginia Medical SchoolNorfolk, Virginia  23507
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Michiana Hematology-OncologySouth Bend, Indiana  46601
Harbor View Cancer CenterBaltimore, Maryland  21225
Southern Illinois Hematology/OncologyCentralia, Illinois  62801
Signal Point Clinical Research CenterMiddletown, Ohio  45042
University Colorado Cancer CenterAurora, Colorado  80045
Georgetown Univ. Medical CenterWashington, District of Columbia  20007
Penn State Milton Hershey Cancer CenterHershey, Pennsylvania  17033