CS-7017 in Combination With Erlotinib 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 (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01199068
First received: August 30, 2010
Last updated: December 21, 2011
Last verified: December 2011

August 30, 2010
December 21, 2011
June 2010
December 2011   (final data collection date for primary outcome measure)
  • Treatment Emergent Adverse Events [ Time Frame: treatment continues until desease progression, unacceptable toxicity or consent withdrawal ] [ Designated as safety issue: No ]
    Evaluate the safety and tolerability of CS-7017 in combination with erlotinib 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: treatment continues until desease progression, unacceptable toxicity or consent withdrawal ] [ Designated as safety issue: No ]
    Evaluate the safety and tolerability of CS-7017 in combination with erlotinib 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 NCT01199068 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)
Phase 1b Study of CS-7017 in Combination With Erlotinib in Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy

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

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
    CS-7017 from 0.25 mg to 0.50 mg twice a daily
    Other Name: CS7017
  • Drug: Erlotinib
    Erlotinib 150 mg once daily
    Other Name: Tarceva
Experimental: CS-7017+Erlotinib
Drug: CS-7017 from 0.25 mg to 0.50 mg twice a daily Drug: Erlotinib 150 mg once daily
Interventions:
  • Drug: CS-7017
  • Drug: Erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2011
December 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)
  • Recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first-line platinum based therapy
  • 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:

  • Prior Tyrosine Kinase Inhibitor (TKI) therapy
  • 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
  • Treatment with anticancer medication within 4 weeks before study treatment, currently enrolled in another investigational drug study, or enrolled in another investigational drug study within 4 weeks of start of 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 (HBsAg)-, hepatitis C virus (HCV)- or human immunodeficiency virus (HIV)-positive or 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 Thiazolidinedione(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
 
NCT01199068
CS7017-A-A110
No
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
Daiichi Sankyo Co., Ltd.
ICON Clinical Research
Not Provided
Daiichi Sankyo Inc.
December 2011

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