Know Cancer

forgot password

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

Phase 1
20 Years
74 Years
Not Enrolling
Non-small-cell Lung Cancer

Thank you

Trial Information

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

Inclusion 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

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

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)

Type of Study:


Study Design:

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

Outcome Measure:

To determine the maximum tolerated dose (MTD) as defined by the dose-limiting toxicity (DLT) of E7080 in combination with carboplatin and paclitaxel.

Outcome Time Frame:

4 Weeks

Safety Issue:


Principal Investigator

Wataru Yusa

Investigator Role:

Study Director

Investigator Affiliation:

Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

February 2009

Completion Date:

July 2011

Related Keywords:

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