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Sponsored by: |
CBA Research |
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Information provided by: | CBA Research |
ClinicalTrials.gov Identifier: | NCT00437749 |
Multiple Drug Resistance is the phenomena whereby cells become resistant to a variety of drugs with different mechanisms of action. Drug resistance remains a significant impediment to successful cancer chemotherapy inhibitors have been developed and are currently in clinical trials. CBT-1 is a natural product currently in clinical trials as an inhibitor
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: CBT-1 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of CBT-1 and Paclitaxel/Carboplatin in Patients With Inoperable Non-Small Cell Lung Cancer |
Estimated Enrollment: | 400 |
Study Start Date: | August 2001 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Lung cancer has the highest incidence and prevalence among cancers in the world and remains the leading cause of cancer-related deaths in Western countries. One-year survival of patients with best supportive care remains low. Non-small-cell lung cancer accounts for almost 85% of all lung cancer cases. Approximately 70% of patients have locally advanced or metastatic disease at presentation and are not candidates for surgery.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, complete abstinence from sexual intercourse
Exclusion Criteria:
Contact: Zinnah Caluag | 859-266-5757 |
United States, Arizona | |
Arizona Clinical Research Center | Recruiting |
Tuscon, Arizona, United States, 85715 | |
Contact: Jarret Schonbrun 520-290-2510 | |
Contact: Mark Canet 520-290-2510 | |
Principal Investigator: Manuel Modiano, MD |
Principal Investigator: | Robert Oldham, MD | CBA Research |
Responsible Party: | CBA Research, Inc ( Beth Gudeman ) |
Study ID Numbers: | CBA-TP0301 |
Study First Received: | February 19, 2007 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00437749 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Non small cell lung cancer Advanced Inoperable |
taxanes carboplatin multi-drug resistance |
Thoracic Neoplasms Respiratory Tract Diseases Paclitaxel Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer |
Carboplatin Taxane Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Carboplatin Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |