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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00806286
First received: December 9, 2008
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Metastatic Non-small Cell Lung Cancer
 Drug: CS7017 tablets
Drug: Paclitaxel
Drug: Carboplatin
Drug: Placebo Tablets
 Phase 2

Study Type: 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
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Progression-free survival (PFS) rate [ Time Frame: week 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median Progression Free Survival [ Time Frame: end of the study ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Median survival [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: end of study ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: December 2008
Study Completion Date: August 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CS-7017 with Paclitaxel and Carboplatin Drug: CS7017 tablets
CS7017 tablets, strength 0.25mg, two tablets, two times daily for twenty-five to thirty months
Drug: Paclitaxel
IV, 200mg/m2, once every three weeks for up to 18 weeks
Drug: Carboplatin
IV, AUC of 6, once every three weeks for up to 18 weeks
Placebo Comparator: Paclitaxel and Carboplatin Drug: Paclitaxel
IV, 200mg/m2, once every three weeks for up to 18 weeks
Drug: Carboplatin
IV, AUC of 6, once every three weeks for up to 18 weeks
Drug: Placebo Tablets
Placebo tablets matching CS-7017 tablets

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806286

  Show 28 Study Locations
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00806286     History of Changes
Other Study ID Numbers: CS7017-A-U202
Study First Received: December 9, 2008
Last Updated: March 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 17, 2013