E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)
1 other identifier
interventional
28
1 country
3
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 daily in combination with carboplatin and paclitaxel to patients with advanced or metastatic non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2009
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2009
CompletedFirst Posted
Study publicly available on registry
January 30, 2009
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
March 6, 2015
CompletedApril 30, 2015
February 1, 2015
2.4 years
January 23, 2009
February 21, 2015
April 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose (MTD)
Tolerability was confirmed by the frequency of occurrence of Dose Limiting Toxicities (DLTs) observed by the end of Cycle 1 in 6 participants.
7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1
Secondary Outcomes (3)
Anti-tumor Effect of E7080 in Combination With Carboplatin and Paclitaxel.
At Screening, on Day 22 of every even cycle, and at discontinuation
Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel.
At various time points until Day 22 of Cycle 1
To Evaluate the Safety and Tolerability of E7080 in Combination With Carboplatin and Paclitaxel.
Throughout the study until 30 days after last dose
Study Arms (2)
E7080 (Dose Escalation Cohort)
EXPERIMENTALThis will be a dose-escalation evaluation of 12-18 participants to determine the maximum tolerated dose of E7080 in combination with paclitaxel and carboplatin.
E7080 (Expansion Cohort)
EXPERIMENTALDosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort.
Interventions
Drug: E7080 will be administered orally starting at a dose of 6 mg twice daily during the 7-day run-in period and for 3 weeks (Cycle 1).
Paclitaxel (200 mg/m2) will be administered intravenously (IV) on Day 1 after administration of E7080.
Carboplatin (AUC 6.0 min/mg/mL) will be administered IV on Day 1 after administration of E7080 and Paclitaxel.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (3)
Unknown Facility
Sunto-gun, Shizuoka, Japan
Unknown Facility
Chuo-ku, Tokyo, Japan
Unknown Facility
Koto-ku, Tokyo, Japan
Related Publications (1)
Nishio M, Horai T, Horiike A, Nokihara H, Yamamoto N, Takahashi T, Murakami H, Yamamoto N, Koizumi F, Nishio K, Yusa W, Koyama N, Tamura T. Phase 1 study of lenvatinib combined with carboplatin and paclitaxel in patients with non-small-cell lung cancer. Br J Cancer. 2013 Aug 6;109(3):538-44. doi: 10.1038/bjc.2013.374. Epub 2013 Jul 16.
PMID: 23860537DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wataru Yusa
- Organization
- Eisai Co., Ltd.
Study Officials
- STUDY DIRECTOR
Wataru Yusa
Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2009
First Posted
January 30, 2009
Study Start
February 1, 2009
Primary Completion
July 1, 2011
Study Completion
October 1, 2011
Last Updated
April 30, 2015
Results First Posted
March 6, 2015
Record last verified: 2015-02