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CS-7017 in Combination With Carboplatin/Paclitaxel in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT01199055
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : December 21, 2018
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by:
Daiichi Sankyo, Inc.

Brief Summary:
The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with carboplatin and paclitaxel, and to assess the pharmacokinetics of CS-7017 in combination with carboplatin and paclitaxel.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: CS-7017 Drug: Carboplatin Drug: Paclitaxel Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1b Study of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC)
Study Start Date : March 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CS-7017+Carboplatin/Paclitaxel
Drug: CS-7017 from 0.25 mg bid to 0.50 mg bid for up to 4~6 cycles (1 cycle: 3 weeks) Drug: Carboplatin IV, AUC of 6, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks) Drug: Paclitaxel IV, 200mg/m2, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks)
Drug: CS-7017
Drug: CS-7017 from 0.25 mg bid to 0.50 mg bid for up to 4~6 cycles (1 cycle: 3 weeks)
Other Name: CS7017

Drug: Carboplatin
Drug: Carboplatin IV, AUC of 6, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks)
Other Name: Paraplatin

Drug: Paclitaxel
Drug: Paclitaxel IV, 200mg/m2, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks)
Other Name: Taxol




Primary Outcome Measures :
  1. treatment emergent adverse events [ Time Frame: 18 weeks ]
    Number of subjects reporting Treatment Emergent Adverse Events (TEAEs) as a measure of safety and tolerability.

  2. plasma concentration of CS-7017 [ Time Frame: 10 weeks ]
    To determine the plasma concentration of CS-7017 at Days 1, 8, 15, 22, 43, and 64 after study drug administration.

  3. treatment-emergent serious adverse events [ Time Frame: 18 weeks ]
    Number of subjects reporting treatment-emergent serious adverse events (SAEs) as a measure of safety and tolerability.



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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 unresectable locally advanced or metastatic (stage IIIb or IV) non-small cell lung cancer (NSCLC)
  • No prior systemic therapy for NSCLC
  • Male or female ≥ 18 years of age
  • Anticipation of more than 3 months survival
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1
  • Adequate organ and bone marrow function

Exclusion Criteria:

  • Anticipation of need for a major surgical procedure or radiation therapy during the study
  • Remaining influence of previous therapies such as radiotherapy, surgery, immunotherapy within 4 weeks prior to start of study treatment
  • History of any of the following events within 6 months prior to start of study treatment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class ≥I congestive heart failure (CHF), cerebrovascular accident or cerebral infarction, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe chronic-obstructive pulmonary disease (COPD) or asthma)
  • Severe edema, ascites fluid, pericardial or pleural effusion or pericardial involvement with the tumor within 6 months prior to start of study treatment, or which require steroid therapy/ diuretic therapy
  • Subjects with brain metastasis (defined as untreated, symptomatic or requiring steroids or anticonvulsant medications to control associated symptoms)
  • Subjects with clinically significant active infection which requires antibiotic therapy, or who are hepatitis B surface antigen (HBs)- or hepatitis C virus (HCV)- or human immunodeficiency virus (HIV)- positive and receiving antiretroviral therapy
  • Subjects with malabsorption syndrome, chronic diarrhea (lasting over 4 weeks), inflammatory bowel disease, or partial bowel obstruction
  • Diabetes mellitus requiring insulin, or a history of poor serum glucose control with the use of non-insulin diabetes medications
  • Treatment with TZDs within 4 weeks prior to start of study treatment
  • History of a second malignancy, with the exception of in situ cervical cancer or adequately treated basal cell or squamous cell carcinoma of the skin
  • Poorly-controlled blood pressure as judged by the Investigator

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): NCT01199055


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Gangnam-gu, Korea, Republic of, 135-710
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
ICON Clinical Research

Responsible Party: Toshio Asami / Assistant Manager, Daiichi Sankyo Tokyo
ClinicalTrials.gov Identifier: NCT01199055     History of Changes
Other Study ID Numbers: CS7017-A-A108
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: July 2011
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/

Keywords provided by Daiichi Sankyo, Inc.:
PPAR gamma agonist
Tumor
Cancer
Antineoplastic Agent
Respiratory Tract Neoplasms
Carboplatin
Paclitaxel
Neoplasms

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