NCT00547651

AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy

AMR PH GL 2007 CL001 Phase 3 A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 637 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer.

Detailed description

Small cell lung cancer represents approximately 13% of the cancers of the lung and presents as extensive stage disease in 60% to 70% of patients. Sites of metastases include bone (35%), liver (25%), bone marrow (20%), brain (10%), extrathoracic lymph nodes (5%), and subcutaneous masses (5%). Small-cell lung cancer has prominent markers of neuroendocrine differentiation. The staging classification for SCLC is the 2-stage Veterans Administration Lung Study Group system that categorizes patients as having limited or extensive disease. Limited stage SCLC is disease confined to 1 hemithorax with or without adjacent mediastinal and/or supraclavicular lymph node involvement, but without a pleural effusion. This extent of disease can be included in a tolerable radiation field. Extensive-disease SCLC is any disease beyond the definition of limited-stage disease. There are few proven treatment options for SCLC patients who fail first-line chemotherapy. New treatment strategies must be evaluated. The need to discover active agents with better toxicity profiles continues to be of great importance. Amrubicin may be an effective treatment for this population.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Amrubicin	Amrubicin for injection is supplied as 50-mg vials. Patients will receive 40 mg/m2 amrubicin as a 5-minute infusion once daily for 3 consecutive days starting on Day 1 of a 21-day course
DRUG	Topotecan	Topotecan for injection is supplied as 4-mg vials. Patients will receive 1.5 mg/m2 as a 30-minute infusion once daily for 5 consecutive days starting on Day 1 of a 21-day course

Timeline

• Start date: 2007-09-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2007-10-22
• Last updated: 2019-11-06

Locations

140 sites across 17 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom