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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT01104155 |
Purpose
This is a Phase 2, multicenter, randomized study of two different dose regimens of eribulin mesylate in combination with intermittent erlotinib in patients with previously treated, advanced non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Drug: eribulin mesylate + erlotinib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Purpose of This Study is to Investigate Two Different Dose Regimens of Eribulin Mesylate in Combination With Intermittent Erlotinib in Patients With Previously Treated, Advanced Non-small Cell Lung Cancer. |
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: eribulin mesylate, 21 day cycle |
Drug: eribulin mesylate + erlotinib
21-day Regimen: Eribulin mesylate given at a dose of 2 mg/m2 as a 2-5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 2-16 of a 21-day cycle.
|
| Active Comparator: eribulin mesylate, 28 day cycle |
Drug: eribulin mesylate + erlotinib
28-day Regimen: Eribulin mesylate given at a dose of 1.4 mg/m2 as a 2-5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15-28 of a 28-day cycle.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
At least one lesion of >/=1.5 cm in longest diameter for non-lymph nodes or >/=1.5 cm in shortest diameter for lymph nodes which is serially measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.17
Exclusion criteria:
Contacts and Locations
Show 60 Study Locations| Study Director: | Eisai US Medical Services | Eisai Inc. |
More Information
| Responsible Party: | Eisai US Medical Services, Eisai 1-888-422-4743 |
| ClinicalTrials.gov Identifier: | NCT01104155 History of Changes |
| Other Study ID Numbers: | E7389-G000-205 |
| Study First Received: | April 12, 2010 |
| Last Updated: | December 8, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
NSCLC |
|
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 Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |