A Phase 3 interventional study of Amrubicin and Topotecan in Small Cell Lung Cancer, sponsored by Celgene. Completed at 140 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-06.
Sponsored by Celgene · Phase 3, Interventional, and Treatment
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 637 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Amrubicin
Drug: Amrubicin
Topotecan
Drug: Topotecan
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
Also known as: amrubidin hydrochloride, Calsed, CNF3140
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
Also known as: Topotecan hydrochloride, Hycamtin
The primary objective is to demonstrate superiority in overall survival of amrubicin compared with topotecan hydrochloride in patients with small cell lung cancer (SCLC) after failure of first-line chemotherapy.
Time frame: Until death from any cause
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of objective response rate
Time frame: Until death
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of progression-free survival.
Time frame: Until death
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of duration of response
Time frame: Until death
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of time to tumor progression
Time frame: Until death
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of safety
Time frame: Until death
To further characterize the clinical benefit of amrubicin compared with topotecan in terms of quality of life
Time frame: Until death
Showing the first 100 of 140 sites across 17 countries.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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