Clinical trial NCT00832819: E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)
Official title: E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-small-cell Lung Cancer
Keywords: Cancer
Lung Cancer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: 7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1
Secondary outcomes:
measure: Anti-tumor Effect of E7080 in Combination With Carboplatin and Paclitaxel.
timeFrame: At Screening, on Day 22 of every even cycle, and at discontinuation
measure: Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel.
timeFrame: At various time points until Day 22 of Cycle 1
measure: To Evaluate the Safety and Tolerability of E7080 in Combination With Carboplatin and Paclitaxel.
timeFrame: Throughout the study until 30 days after last dose
Other outcomes:
Locations:
city: Sunto-gun
country: Japan
state: Shizuoka
city: Chuo-ku
country: Japan
state: Tokyo
city: Koto-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
name: Wataru Yusa
role: STUDY_DIRECTOR
References:
citation: Nishio M, Horai T, Horiike A, Nokihara H, Yamamoto N, Takahashi T, Murakami H, Yamamoto N, Koizumi F, Nishio K, Yusa W, Koyama N, Tamura T. Phase 1 study of lenvatinib combined with carboplatin and paclitaxel in patients with non-small-cell lung cancer. Br J Cancer. 2013 Aug 6;109(3):538-44. doi: 10.1038/bjc.2013.374. Epub 2013 Jul 16.