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

Eisai Co., Ltd.28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small-cell Lung Cancer

Interventions

E7080DRUG

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).

E7080DRUG

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).

PaclitaxelDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 74 Years

Medical Language ↔ Plain English

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.

Locations (3)

Unnamed facility

Sunto-gun, Shizuoka, Japan

Unnamed facility

Chuo-ku, Tokyo, Japan

Unnamed facility

Koto-ku, Tokyo, Japan

Outcomes

Primary Outcomes

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.

Time frame: 7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1

Secondary Outcomes

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

Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel.

Time frame: At various time points until Day 22 of Cycle 1

To Evaluate the Safety and Tolerability of E7080 in Combination With Carboplatin and Paclitaxel.

Refer safety section for safety analysis

Time frame: Throughout the study until 30 days after last dose

Data from ClinicalTrials.gov

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