Back to resultsE7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)
Primary Purpose
Non-small-cell Lung Cancer
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
E7080
E7080
Paclitaxel
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Non-small-cell Lung Cancer focused on measuring Cancer, Lung Cancer
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
E7080 (Dose Escalation Cohort)
E7080 (Expansion Cohort)
Arm Description
This will be a dose-escalation evaluation of 12-18 participants to determine the maximum tolerated dose of E7080 in combination with paclitaxel and carboplatin.
Dosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Anti-tumor Effect of E7080 in Combination With Carboplatin and Paclitaxel.
Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel.
To Evaluate the Safety and Tolerability of E7080 in Combination With Carboplatin and Paclitaxel.
Refer safety section for safety analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00832819
Brief Title
E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)
Official Title
E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small-cell Lung Cancer
Keywords
Cancer, Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E7080 (Dose Escalation Cohort)
Arm Type
Experimental
Arm Description
This will be a dose-escalation evaluation of 12-18 participants to determine the maximum tolerated dose of E7080 in combination with paclitaxel and carboplatin.
Arm Title
E7080 (Expansion Cohort)
Arm Type
Experimental
Arm Description
Dosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort.
Intervention Type
Drug
Intervention Name(s)
E7080
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
E7080
Intervention Description
Maximum tolerated dose determined in the Dose-Escalation Cohort will be administered to the Expansion Cohort. After E7080 is taken on Day 1, paclitaxel (200 mg/m2) will be administered intravenously (IV), followed by IV carboplatin (AUC 6.0 min/mg/mL).
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel (200 mg/m2) will be administered intravenously (IV) on Day 1 after administration of E7080.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin (AUC 6.0 min/mg/mL) will be administered IV on Day 1 after administration of E7080 and Paclitaxel.
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD)
Description
Tolerability was confirmed by the frequency of occurrence of Dose Limiting Toxicities (DLTs) observed by the end of Cycle 1 in 6 participants.
Time Frame
7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1
Secondary Outcome Measure Information:
Title
Anti-tumor Effect of E7080 in Combination With Carboplatin and Paclitaxel.
Time Frame
At Screening, on Day 22 of every even cycle, and at discontinuation
Title
Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel.
Time Frame
At various time points until Day 22 of Cycle 1
Title
To Evaluate the Safety and Tolerability of E7080 in Combination With Carboplatin and Paclitaxel.
Description
Refer safety section for safety analysis
Time Frame
Throughout the study until 30 days after last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wataru Yusa
Organizational Affiliation
Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Sunto-gun
State/Province
Shizuoka
Country
Japan
City
Chuo-ku
State/Province
Tokyo
Country
Japan
City
Koto-ku
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
23860537
Citation
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.
Results Reference
derived
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E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)
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