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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00832819
Recruitment Status : Completed
First Posted : January 30, 2009
Results First Posted : March 6, 2015
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Non-small-cell Lung Cancer Drug: E7080 Drug: Paclitaxel Drug: Carboplatin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)
Study Start Date : February 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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).

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

Drug: Carboplatin
Carboplatin (AUC 6.0 min/mg/mL) will be administered IV on Day 1 after administration of E7080 and Paclitaxel.
Experimental: E7080 (Expansion Cohort)
Dosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort.
 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).

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

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


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: 7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1 ]
    Tolerability was confirmed by the frequency of occurrence of Dose Limiting Toxicities (DLTs) observed by the end of Cycle 1 in 6 participants.


Secondary Outcome Measures :
  1. 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 ]
  2. Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel. [ Time Frame: At various time points until Day 22 of Cycle 1 ]
  3. 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 ]
    Refer safety section for safety analysis


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832819


Locations
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Japan
Sunto-gun, Shizuoka, Japan
Chuo-ku, Tokyo, Japan
Koto-ku, Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
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Study Director: Wataru Yusa Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT00832819    
Other Study ID Numbers: E7080-J081-110
First Posted: January 30, 2009    Key Record Dates
Results First Posted: March 6, 2015
Last Update Posted: April 30, 2015
Last Verified: February 2015
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Cancer
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
 Carboplatin
Lenvatinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors