E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-small-cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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E7080 (Dose Escalation Cohort)

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.

Group Type EXPERIMENTAL

E7080

Intervention Type DRUG

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

Intervention Type DRUG

Paclitaxel (200 mg/m2) will be administered intravenously (IV) on Day 1 after administration of E7080.

Carboplatin

Intervention Type DRUG

Carboplatin (AUC 6.0 min/mg/mL) will be administered IV on Day 1 after administration of E7080 and Paclitaxel.

E7080 (Expansion Cohort)

Dosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort.

Group Type EXPERIMENTAL

E7080

Intervention Type DRUG

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).

Paclitaxel

Intervention Type DRUG

Paclitaxel (200 mg/m2) will be administered intravenously (IV) on Day 1 after administration of E7080.

Carboplatin

Intervention Type DRUG

Carboplatin (AUC 6.0 min/mg/mL) will be administered IV on Day 1 after administration of E7080 and Paclitaxel.

Interventions

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E7080

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

E7080

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

Paclitaxel

Paclitaxel (200 mg/m2) will be administered intravenously (IV) on Day 1 after administration of E7080.

Intervention Type DRUG

Carboplatin

Carboplatin (AUC 6.0 min/mg/mL) will be administered IV on Day 1 after administration of E7080 and Paclitaxel.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects with a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC).
2. Locally advanced and/or metastatic non-small cell lung cancer (NSCLC) (Stage IIIB/IV).
3. Subjects with at least one measurable tumor lesion by Response Evaluation Criteria In Solid Tumors (RECIST).
4. Subjects with Performance Status (PS) 0-1.
5. Subjects with adequate organ function.

Exclusion Criteria

1. Subjects who have ever received the following therapy for non-small cell lung cancer (NSCLC):

1. Chemotherapy
2. Biological or immunotherapies
3. Surgery for primary focus
4. The radiation therapy for primary focus
2. Subjects with the severe complications or disease history.
3. Subjects with brain metastasis accompanying clinical symptoms or requiring treatment.
4. Subjects with simultaneous or metachronous cancers.
5. Subjects who cannot take oral medication.
6. Subjects who are using drugs that strongly inhibit or induce cytochrome P450 (CYP) 3A4.

Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No