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Completed

NCT Number: NCT00832819

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

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.

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Key information

Conditions

Non-Small-Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sunto-gun, Shizuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC).
  • Locally advanced and/or metastatic non-small cell lung cancer (NSCLC) (Stage IIIB/IV).
  • Subjects with at least one measurable tumor lesion by Response Evaluation Criteria In Solid Tumors (RECIST).
  • Subjects with Performance Status (PS) 0-1.
  • Subjects with adequate organ function.

Exclusion criteria

  • Subjects who have ever received the following therapy for non-small cell lung cancer (NSCLC):
  • Chemotherapy
  • Biological or immunotherapies
  • Surgery for primary focus
  • The radiation therapy for primary focus
  • Subjects with the severe complications or disease history.
  • Subjects with brain metastasis accompanying clinical symptoms or requiring treatment.
  • Subjects with simultaneous or metachronous cancers.
  • Subjects who cannot take oral medication.
  • Subjects who are using drugs that strongly inhibit or induce cytochrome P450 (CYP) 3A4.

Treatment and study plan

E7080

Drug

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).

paclitaxel

Drug

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

carboplatin

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 30, 2009
Registry last updated
Apr 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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