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Sponsored by: |
AmpliMed Corporation |
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Information provided by: | AmpliMed Corporation |
ClinicalTrials.gov Identifier: | NCT00697060 |
Protocol AMP-024 is a Phase 2 study of imexon plus docetaxel for patients with previously treated lung cancer that has spread in the body. Docetaxel is approved by the Food and Drug Administration (FDA) as a second line therapy for this cancer. The imexon is administered on days 1-5 and the docetaxel on day 1 of every 3 week cycle. The objective of the protocol is to determine if the combination of imexon plus docetaxel is safe and effective.
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung |
Drug: Imexon + docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Phase II Trial of the Safety and Efficacy of Amplimexon® (Imexon for Injection) in Combination With Taxotere® (Docetaxel) for Previously Treated Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 49 |
Study Start Date: | August 2009 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Stage 1/2: Experimental
Imexon plus docetaxel
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Drug: Imexon + docetaxel
Imexon at 1300 mg/m2 days 1-5 Docetaxel at 75 mg/m2 day 1
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject with metastatic disease (Appendix D) who have received no more than 2 prior chemotherapy regimens for their metastatic disease.
Adequate renal function defined by:
Adequate hematologic function defined by:
Adequate hepatic function defined by:
Exclusion Criteria:
Contact: Michelle Boytim, PhD | 520-529-1000 | mboytim@amplimed.com |
United States, California | |
USC Norris Cotton Cancer Center | |
Los Angeles, California, United States | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States | |
United States, Texas | |
Mary Crowley Research Center | |
Dallas, Texas, United States |
Study Director: | Tom Williams, MD | AmpliMed Corporation |
Responsible Party: | AmpliMed ( Tom Williams ) |
Study ID Numbers: | AMP024 |
Study First Received: | June 11, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00697060 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metastatic Previously treated |
Docetaxel Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Pharmacologic Actions Carcinoma Docetaxel Neoplasms |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |