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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00662636 |
RATIONALE: Dasatinib and lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of dasatinib and lapatinib when given together in treating patients with advanced solid tumors that cannot be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: dasatinib Drug: lapatinib ditosylate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of the Combination of Dasatinib and Lapatinib |
Estimated Enrollment: | 50 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Tissue and blood samples are collected periodically for pharmacokinetic and correlative studies. Samples are analyzed for biomarkers, circulating tumor cells, tyrosine phosphorylated or total MAP-K, EGFR, Her2, and FAK, among other potential markers of activity and/or response by immunofluorescence. Circulating osteoclasts are also assessed by flow cytometry.
After completion of treatment study, patients are followed for 3 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed advanced solid tumor
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior radiotherapy
United States, Arizona | |
Mayo Clinic Scottsdale | Recruiting |
Scottsdale, Arizona, United States, 85259-5499 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Florida | |
Mayo Clinic - Jacksonville | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 |
Study Chair: | Charles Erlichman, MD | Mayo Clinic |
Study ID Numbers: | CDR0000593527, MAYO-MC0616 |
Study First Received: | April 18, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00662636 |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific |
Dasatinib Lapatinib |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |