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Sponsors and Collaborators: |
University of Nebraska Bristol-Myers Squibb |
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Information provided by: | University of Nebraska |
ClinicalTrials.gov Identifier: | NCT00550615 |
Primary Objective:
Secondary Objectives:
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma |
Drug: Dasatinib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of Dasatinib in Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) (BMS Protocol 180129) |
Estimated Enrollment: | 47 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | September 2010 |
Arms | Assigned Interventions |
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Dose Cohort # 1: Active Comparator |
Drug: Dasatinib
Dasatinib will be orally administered once daily for 28 day cycles. There will be three dose cohorts for the Dasatinib in the Phase I portion of this trial. A minimum of three patients will be enrolled into each of the following dose cohorts: Dose cohort # 1 will be 100 mg per day The MTD will be determined in the Phase I portion of this trial. An additional 29 patients using the Two-Stage Simon design will be enrolled into Phase II using the MTD determined in Phase I. |
Dose Cohort # 2: Active Comparator |
Drug: Dasatinib
Dose cohort # 2 will be 150 mg per day
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Dose Cohort # 3: Active Comparator |
Drug: Dasatinib
Dose cohort # 3 will be 200 mg per day
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Primary:
Secondary Objective:
Treatment Plan
This study has two phases of treatment, Phase I and Phase II. The Phase I portion of the trial will consist of a dose escalation plan with 3-6 patients being enrolled into each dose cohort. The doses of Dasatinib used in Phase I are 100 mg, 150 mg, and 200 mg. The dose that is found to be tolerated the best and also has the best treatment results will be used for Phase II. An additional 29 patients will be enrolled into Phase II.
All patients will receive Dasatinib in this study. Dasatinib will be administered orally (by mouth) once daily for 28 day cycles. A cycle will be considered 28 days. Dosing will be continuous with no interruptions, unless instructed to interrupt treatment by the treating physician.
The patient will be restaged after every 2 cycles of therapy, every even cycle. Therapy may continue as long as there are no clinical signs of NHL progressing and the patient is tolerating the treatment with no side effects related to the therapy. If the patient is removed from study for any reason, he/she will be followed for survival until death.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate Laboratory Parameters:
Exclusion Criteria:
Concurrent medical condition which may increase the risk of toxicity, including:
Cardiac Symptoms, consider the following:
History of significant bleeding disorder unrelated to cancer, including:
Concomitant Medications, consider the following prohibitions:
Women:
Contact: Maribeth Hohenstein, RN | 402-559-9053 | mahohens@unmc.edu |
Contact: Carolyn Chamberlain, RN | 402-559-7507 | cchamberlain@unmc.edu |
United States, Nebraska | |
University of Nebraska Medical Center - Internal Medicine Section of Oncology/Hematology | Recruiting |
Omaha, Nebraska, United States, 68198-7680 | |
Contact: Maribeth Hohenstein, RN 402-559-9053 mahohens@unmc.edu | |
Contact: Carolyn Chamberlain, RN 402-559 7507 cchamberlain@unmc.edu | |
Principal Investigator: Julie Vose, MD |
Principal Investigator: | Julie Vose, M.D. | University of Nebraska |
Responsible Party: | University of Nebraska Medical Center ( Julie Vose, M.D. Principal Investigator ) |
Study ID Numbers: | IRB#244-07-FB, BMS Protocol 180129 |
Study First Received: | October 26, 2007 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00550615 |
Health Authority: | United States: Institutional Review Board |
Non-Hodgkins Lymphoma Relapsed Non Hodgkins Lymphoma Refractory Non Hodgkins Lymphoma Dasatinib |
Lymphatic Diseases Immunoproliferative Disorders Dasatinib Lymphoma, small cleaved-cell, diffuse |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |