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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00832819
First received: January 23, 2009
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Non-small-cell Lung Cancer
Drug: E7080 (Dose Escalation-Cohort)
Drug: E7080 (Expansion Cohort)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • To determine the maximum tolerated dose (MTD) as defined by the dose-limiting toxicity (DLT) of E7080 in combination with carboplatin and paclitaxel. [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the safety and tolerability of E7080 in combination with carboplatin and paclitaxel. [ Time Frame: Throughout the study until 30 days after last dose ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics and pharmacodynamics of E7080 in combination with carboplatin and paclitaxel. [ Time Frame: At various time points until Day 22 of Cycle 1 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: February 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: E7080 (Dose Escalation-Cohort)
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). 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). This will be a dose-escalation evaluation of 12-18 patients to determine the maximum tolerated dose of E7080 in combination with paclitaxel and carboplatin.
Experimental: 2 Drug: E7080 (Expansion Cohort)
Dosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort. Administration of paclitaxel and carboplatin will continue at the same dose level in Cycle 2.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832819

Locations
Japan
Sunto-gun, Shizuoka, Japan
Chuo-ku, Tokyo, Japan
Koto-ku, Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Wataru Yusa Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
  More Information

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT00832819     History of Changes
Other Study ID Numbers: E7080-J081-110
Study First Received: January 23, 2009
Last Updated: September 27, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Cancer
Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 22, 2014