Status:
COMPLETED
E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Non-small-cell Lung Cancer
Eligibility:
All Genders
20-74 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determined the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered continually twice ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects with a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC).
- Locally advanced and/or metastatic non-small cell lung cancer (NSCLC) (Stage IIIB/IV).
- Subjects with at least one measurable tumor lesion by Response Evaluation Criteria In Solid Tumors (RECIST).
- Subjects with Performance Status (PS) 0-1.
- Subjects with adequate organ function.
- Exclusion criteria:
- Subjects who have ever received the following therapy for non-small cell lung cancer (NSCLC):
- Chemotherapy
- Biological or immunotherapies
- Surgery for primary focus
- The radiation therapy for primary focus
- Subjects with the severe complications or disease history.
- Subjects with brain metastasis accompanying clinical symptoms or requiring treatment.
- Subjects with simultaneous or metachronous cancers.
- Subjects who cannot take oral medication.
- Subjects who are using drugs that strongly inhibit or induce cytochrome P450 (CYP) 3A4.
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00832819
Start Date
February 1 2009
End Date
October 1 2011
Last Update
April 30 2015
Active Locations (3)
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1
Sunto-gun, Shizuoka, Japan
2
Chuo-ku, Tokyo, Japan
3
Koto-ku, Tokyo, Japan