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Sponsors and Collaborators: |
Sarah Cannon Research Institute SCRI Oncology Research Consortium Bayer |
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Information provided by: | Sarah Cannon Research Institute |
ClinicalTrials.gov Identifier: | NCT00536575 |
This is a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients.
The initial patients on the dose-finding portion of this study will be enrolled through a single institution.
Following establishment of the Phase II dose the study will open enrollment throughout the Sarah Cannon Research Institute (SCRI) Oncology Research Consortium.
The purpose of this study is to develop the combination of bortezomib (which is proven to be clinically active in patients with multiple myeloma) with sorafenib (a potent inhibitor of angiogenesis). This regimen will be developed in a schedule that is convenient for patients, and that is as minimally toxic to patients as possible.
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: Sorafenib and Bortezomib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Trial of Sorafenib and Weekly Bortezomib in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma |
Estimated Enrollment: | 50 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
The brief Phase I portion will require cohorts of 3 patients per dose level as follows:
Dose Level 1: The initial dose level of Sorafenib is 200 mg po bid continuous dosing of each 5 week course.
Bortezomib 1.3mg/m2 IV bolus on days 1, 8, 15, and 22 of each 5-week cycle.
Dose Level 2: Sorafenib 200 mg po bid continuous dosing of each 5 week course. Bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 of each 5-week cycle.
Dose Level 3: Sorafenib 400 mg po bid continuous dosing of each 5 week course. Bortezomib 1.6mg/m2 IV bolus on days 1, 8, 15, and 22 of each 5-week cycle.
Patients in the Phase II portion will receive bortezomib and sorafenib at doses defined in the Phase I portion of the trial.
Primary Objective:
To evaluate the efficacy of sorafenib with weekly bortezomib, as measured by objective response rate and progression-free survival in patients with relapsed/refractory multiple myeloma.
Secondary Objective:
To evaluate the feasibility and toxicity of sorafenib with weekly bortezomib in the treatment of patients with relapsed/refractory multiple myeloma.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ian W. Flinn, M.D. | (615) 329-7274 | iflinn@tnonc.com |
Contact: Trials Info | (615) 329-7274 | trialsinfo@scresearch.net |
United States, Maryland | |
Center for Cancer and Blood Disorders | Recruiting |
Bethesda, Maryland, United States, 20817 | |
United States, Tennessee | |
Tennessee Oncology, PLLC | Recruiting |
Nashville, Tennessee, United States, 37023 |
Study Chair: | Ian W. Flinn, M.D. | SCRI Oncology Research Consortium |
Responsible Party: | SCRI Oncology Research Consortium ( Ian W. Flinn, M.D. ) |
Study ID Numbers: | SCRI MM 14 |
Study First Received: | September 26, 2007 |
Last Updated: | June 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00536575 History of Changes |
Health Authority: | United States: Institutional Review Board |
Multiple Myeloma Relapsed Refractory Sorafenib Bortezomib |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias Hemostatic Disorders |
Protein Kinase Inhibitors Protease Inhibitors Multiple Myeloma Hemorrhagic Disorders Lymphoproliferative Disorders Sorafenib Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Blood Protein Disorders Hematologic Diseases Bortezomib Vascular Diseases Enzyme Inhibitors Paraproteinemias Hemostatic Disorders |
Protein Kinase Inhibitors Pharmacologic Actions Protease Inhibitors Multiple Myeloma Neoplasms Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Lymphoproliferative Disorders Sorafenib Neoplasms, Plasma Cell |