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Sponsored by: |
Exelixis |
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Information provided by: | Exelixis |
ClinicalTrials.gov Identifier: | NCT00464113 |
The purpose of this study is to determine the safest dose of the BCR-ABL inhibitor XL228, how often it should be taken, and how well people with leukemia tolerate XL228.
Condition | Intervention | Phase |
---|---|---|
Chronic Myeloid Leukemia Leukemia, Lymphoblastic, Acute, Philadelphia-Positive |
Drug: XL228 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL228 Administered Intravenously to Subjects With Chronic Myeloid Leukemia (CML) or Philadelphia-Chromosome-Positive Acute Lymphocytic Leukemia (Ph+ ALL) |
Estimated Enrollment: | 100 |
Study Start Date: | April 2007 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
once-weekly dosing
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Drug: XL228
1-hour IV infusion
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2: Experimental
twice-weekly dosing
|
Drug: XL228
1-hour IV infusion
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The subject has a confirmed pathologic diagnosis as evidenced by the presence of the BCR-Abl translocation [t(9;22)] by fluorescence in situ hybridization (FISH), cytogenetics, or quantitative polymerase chain reaction (QPCR) of one of the following:
CML
The subject has one of the following:
Exclusion Criteria:
Contact: Exelixis Contact Line | 1-866-939-4041 |
United States, California | |
University of California San Francisco | Recruiting |
San Francisco, California, United States, 94143-1270 | |
Contact: Patty Olszynski 415-502-1564 POlszynski@medicine.ucsf.edu | |
Principal Investigator: Neil P. Shah, MD, PhD | |
UCLA School of Medicine | Recruiting |
Los Angeles, California, United States, 90095-1678 | |
Contact: Kimhouy Tong 310-794-0738 ktong@mednet.ucla.edu | |
Principal Investigator: Ronald Paquette, MD | |
United States, District of Columbia | |
Georgetown University Medical Center, Lombardi Comprehensive Cancer Center | Recruiting |
Washington, District of Columbia, United States, 20007 | |
Contact: Amanda Begley, RN, BSN 202-687-6185 | |
Principal Investigator: Khaled El-Shami, MD | |
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Michelle Burton 813-745-4210 Michelle.Burton@moffitt.org | |
Principal Investigator: Javier Pinilla-Ibarz, MD, PhD | |
United States, Michigan | |
University of Michigan Health System | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Tonya Neil 734-764-6847 | |
Principal Investigator: Moshe Talpaz, MD | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Gwen Hunter 713-563-1681 dolhunter@mdanderson.org | |
Principal Investigator: Jorge Cortes, MD |
Responsible Party: | Exelixis, Inc. ( Lynne Bui, MD/Senior Director, Clinical Research ) |
Study ID Numbers: | XL228-001 |
Study First Received: | April 18, 2007 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00464113 |
Health Authority: | United States: Food and Drug Administration |
Myeloid Leukemia Lymphocytic Leukemia Ph+ ALL |
Chromosomal abnormalities Philadelphia Chromosome Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Chronic myelogenous leukemia Hematologic Diseases Myeloproliferative Disorders |
Leukemia, Myeloid Leukemia Lymphatic Diseases Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chromosome Aberrations Lymphoproliferative Disorders Bone Marrow Diseases Lymphoma |
Neoplasms Pathologic Processes Neoplasms by Histologic Type Immune System Diseases Translocation, Genetic |