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Sponsored by: |
SuperGen |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00504205 |
RATIONALE: MP470 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This clinical trial is studying the side effects and best dose of MP470 in treating patients with unresectable or metastatic refractory solid tumor, Hodgkin's lymphoma, or non-Hodgkin's lymphoma.
Condition | Intervention |
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Lymphoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: multitargeted receptor tyrosine kinase inhibitor MP470 Other: laboratory biomarker analysis Other: pharmacological study Procedure: positron emission tomography |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Safety Study to Determine the Maximum Tolerated Dose, Pharmacokinetics and Pharmacodynamics of Oral MP470, a Multi-Targeted Tyrosine Kinase Inhibitor, in Patients With Solid Malignancies |
Estimated Enrollment: | 30 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral multitargeted receptor tyrosine kinase inhibitor MP470 until the maximum tolerated dose is determined.
Pharmacokinetic and pharmacodynamic analyses are carried out to determine changes in phosphorylation of extracellular signal-regulated kinase (ERK), Rad51 expression, number of circulating tumor cells (CTCs), and tumor glucose metabolism measured by 2-[18F]fluoro-2-deoxyglucose positron emission tomography (FDG-PET).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histological or cytological diagnosis of unresectable or metastatic solid-tumor cancer that is refractory to standard therapies OR for which no standard therapy exists
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
United States, Arizona | |
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea | Recruiting |
Scottsdale, Arizona, United States, 85258-4512 | |
Contact: Raoul Tibes, MD 480-323-1350 | |
United States, Texas | |
South Texas Accelerated Research Therapeutics | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Anthony W. Tolcher, MD 210-593-5255 |
Study Chair: | Gregory Berk, MD | SuperGen |
Study ID Numbers: | CDR0000556524, SUPERGEN-SGI-0470-01, VPCCS-SGI-0470-01 |
Study First Received: | July 17, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00504205 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue intraocular lymphoma nodal marginal zone B-cell lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent grade 1 follicular lymphoma |
recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent mycosis fungoides/Sezary syndrome recurrent small lymphocytic lymphoma splenic marginal zone lymphoma stage III adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult Hodgkin lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III adult T-cell leukemia/lymphoma |
Lymphoma, Mantle-Cell Lymphoma, Follicular Tyrosine Central Nervous System Lymphoma, Primary Mantle Cell Lymphoma Sezary Syndrome Lymphoma, B-Cell, Marginal Zone Mycosis Fungoides Lymphoblastic Lymphoma Follicular Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Leukemia Mycoses |
Cutaneous T-cell Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, T-Cell Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-cell Leukemia, B-cell, Chronic Hodgkin Disease Lymphoma Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Hodgkin Lymphoma, Adult Leukemia-Lymphoma, Adult T-Cell Immunoblastic Lymphadenopathy Hodgkin's Disease |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |