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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Bristol-Myers Squibb |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00858403 |
The main purpose of this study is to learn how patients with Advanced Non-Small Cell Lung Cancer (NSCLC) respond to the study drug Dasatinib. The study drug, Dasatinib, has been approved by the U.S. Food and Drug Administration (FDA) for treatment of leukemia, but has not been approved for the treatment of other kinds of cancer. The use of Dasatinib in this study is considered experimental.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: Dasatinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Dasatinib in Advanced Non-small Cell Lung Cancer With Ex Vivo and In Vivo Assessment of Tumor Target Modulation |
Estimated Enrollment: | 40 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Dasatinib
Take tablets of Dasatinib by mouth once a day.
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Cycle 1 - C1D1: Patients will have complete H&P, CBC, CMP and EKG on day 1. Each cycle is 28 days. The C1D1 EKG can be omitted if the patient has no new cardiac symptoms and has not starting taking any medication known to affect QTc prolongation. Any residual toxicity from prior therapy for cancer will be recorded. Blood will be drawn for assessment of serum markers. The patient will begin dasatinib at the starting C1D1 on a daily basis. C1D10-20: Patients will have a second biopsy to obtain additional tumor material to examine biological effects of dasatinib on signaling pathways. Dasatinib will be taken first thing in the morning and the patient will log the time. Blood will also be drawn for pharmacokinetic assessments of dasatinib levels in plasma and the time recorded. Four FNA aspirates and 2 core biopsies can be obtained either at the bedside for palpable lesions or through appropriate image-guided techniques (CT or US) at the discretion of the treating physician in consultation with radiology. The time of the biopsy will be recorded. One core biopsy should be immediately fixed in formalin and the other core biopsy should be snap frozen in liquid nitrogen. Cycle 2 - C2D1: Patients will be seen by the treating physician and have complete H&P, CBC, and CMP. Blood will be drawn for assessment of serum markers. Toxicity of dasatinib will be assessed. The patient will continue to take daily doses of dasatinib on a daily basis. C2D22: Patients will undergo reevaluation for tumor measurements. This assessment can occur on C2D22 ±7 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate Organ Function:
Concomitant Medications:
Women of childbearing potential (WOCBP):
Exclusion Criteria:
Concurrent medical condition which may increase the risk of toxicity, including:
Cardiac Symptoms; any of the following should be considered for exclusion:
History of significant bleeding disorder unrelated to cancer, including:
Concomitant Medications, any of the following should be considered for exclusion:
Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib)
Women:
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Aaron Becker, RN, B.S.N. 813-745-4679 aaron.becker@moffitt.org | |
Principal Investigator: Eric Haura, M.D. | |
Sub-Investigator: Soner Altiok, M.D. | |
Sub-Investigator: Scott Antonia, M.D. | |
Sub-Investigator: Gerold Bepler, M.D., Ph.D. | |
Sub-Investigator: Alberto Chiappori, M.D. | |
Sub-Investigator: Jhanelle Gray, M.D. | |
Sub-Investigator: Tawee Tanvetyanon, M.D. | |
Sub-Investigator: Charles Williams, M.D. |
Principal Investigator: | Eric Haura, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute ( Eric Haura, M.D. ) |
Study ID Numbers: | MCC-15656, USF IRB 107301, CA180214 |
Study First Received: | March 5, 2009 |
Last Updated: | August 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00858403 History of Changes |
Health Authority: | United States: Institutional Review Board |
Advanced Non-small Cell Lung Cancer |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Dasatinib Lung Diseases |
Non-small Cell Lung Cancer Protein Kinase Inhibitors Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Dasatinib Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |