|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00303797 |
Purpose
RATIONALE: Sorafenib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of cancer cells by blocking blood flow to the cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib and bortezomib in treating patients with advanced cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Multiple Myeloma and Plasma Cell Neoplasm Unspecified Adult Solid Tumor, Protocol Specific |
Drug: bortezomib Drug: sorafenib tosylate |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study of the Raf Kinase/VEGFR Inhibitor BAY 43-9006 in Combination With the Proteasome Inhibitor PS-341 in Patients With Advanced Malignancies |
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2005 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 groups according to disease type.
Cohorts of 3-6 patients receive escalating doses of sorafenib and bortezomib until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed for 3 months.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Multiple myeloma or chronic lymphocytic leukemia requiring treatment (group II - maximum tolerated dose phase)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 4 weeks since major surgery (e.g., laparotomy) (2 weeks for minor surgery)
No concurrent therapeutic anticoagulation
Contacts and Locations| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Study Chair: | Shaji K. Kumar, MD | Mayo Clinic |
| Investigator: | Neil E. Kay, MD | Mayo Clinic |
More Information
| ClinicalTrials.gov Identifier: | NCT00303797 History of Changes |
| Other Study ID Numbers: | CDR0000458075, MAYO-MC0511, NCI-7082 |
| Study First Received: | March 15, 2006 |
| Last Updated: | June 19, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
unspecified adult solid tumor, protocol specific stage IV chronic lymphocytic leukemia stage III multiple myeloma refractory multiple myeloma refractory chronic lymphocytic leukemia |
|
Neoplasms Leukemia Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Bortezomib Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors |