Status:
COMPLETED
CS-7017 in Combination With Carboplatin/Paclitaxel in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Collaborating Sponsors:
ICON Clinical Research
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 pharmacoki...
Eligibility Criteria
Inclusion
- 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
- 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 thiazolidinediones (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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01199055
Start Date
March 1 2010
End Date
July 1 2011
Last Update
July 7 2020
Active Locations (1)
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1
Samsung Medical Center
Seoul, Gangnam-gu, South Korea, 135-710