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

This study has been completed.
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT01199055
First received: August 30, 2010
Last updated: July 11, 2011
Last verified: July 2011

August 30, 2010
July 11, 2011
March 2010
April 2011   (final data collection date for primary outcome measure)
  • treatment emergent adverse events [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    Number of subjects reporting Treatment Emergent Adverse Events (TEAEs) as a measure of safety and tolerability.
  • plasma concentration of CS-7017 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    To determine the plasma concentration of CS-7017 at Days 1, 8, 15, 22, 43, and 64 after study drug administration.
  • treatment-emergent serious adverse events [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    Number of subjects reporting treatment-emergent serious adverse events (SAEs) as a measure of safety and tolerability.
Same as current
Complete list of historical versions of study NCT01199055 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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CS-7017 in Combination With Carboplatin/Paclitaxel in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)
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)

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • 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
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)
Interventions:
  • Drug: CS-7017
  • Drug: Carboplatin
  • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
July 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01199055
CS7017-A-A108
No
Toshio Asami / Assistant Manager, Daiichi Sankyo Tokyo
Daiichi Sankyo Co., Ltd.
ICON Clinical Research
Not Provided
Daiichi Sankyo Inc.
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP