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

Non-small-cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832819
• Other study ID #: E7080-J081-110
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2009
• Last updated: April 9, 2015
• Start date: February 2009
• Est. completion date: October 2011

Study information

• Verified date: February 2015
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer

Intervention

Drug:
• 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).
• 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).
• Paclitaxel
Paclitaxel (200 mg/m2) will be administered intravenously (IV) on Day 1 after administration of E7080.
• Carboplatin
Carboplatin (AUC 6.0 min/mg/mL) will be administered IV on Day 1 after administration of E7080 and Paclitaxel.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Anti-tumor Effect of E7080 in Combination With Carboplatin and Paclitaxel.		At Screening, on Day 22 of every even cycle, and at discontinuation	No
Secondary	Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel.		At various time points until Day 22 of Cycle 1	No
Secondary	To Evaluate the Safety and Tolerability of E7080 in Combination With Carboplatin and Paclitaxel.	Refer safety section for safety analysis	Throughout the study until 30 days after last dose	Yes