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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00806286
Recruitment Status : Completed
First Posted : December 10, 2008
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2008
Actual Primary Completion Date : January 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Progression-free survival (PFS) rate [ Time Frame: week 18 ]

Secondary Outcome Measures :
  1. Median Progression Free Survival [ Time Frame: end of the study ]
  2. Objective response rate [ Time Frame: end of study ]
  3. Median survival [ Time Frame: end of study ]
  4. Overall survival [ Time Frame: end of study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806286


  Show 28 Study Locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.

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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00806286     History of Changes
Other Study ID Numbers: CS7017-A-U202
First Posted: December 10, 2008    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: March 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Efatutazone
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action