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

Eisai

Status and phase: Completed; Phase 1

Conditions: Non-small-cell Lung Cancer

Treatments: Drug: E7080; Drug: Paclitaxel; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00832819

E7080-J081-110

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

E7080 (Dose Escalation Cohort)

Experimental group

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.

Treatment:

Drug: Carboplatin

Drug: E7080

Drug: Paclitaxel

Drug: E7080

E7080 (Expansion Cohort)

Experimental group

Description:

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

Treatment:

Drug: Carboplatin

Drug: E7080

Drug: Paclitaxel

Drug: E7080