Spots Global Cancer Trial Database for Cabozantinib S-Malate in Treating Patients With Advanced Solid Tumors and Human Immunodeficiency Virus
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Trial Identification
Brief Title: Cabozantinib S-Malate in Treating Patients With Advanced Solid Tumors and Human Immunodeficiency Virus
Official Title: Phase I Trial of Cabozantinib (XL184) for Advanced Solid Tumors in Persons With HIV Infection
Study ID: NCT01822522
Study Description
Brief Summary: This phase I trial studies the side effects and best dose of cabozantinib s-malate in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment and human immunodeficiency virus. Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the safety and tolerability of cabozantinib (XL184) (cabozantinib s-malate) as a single agent in solid tumor participants with human immunodeficiency virus (HIV) infection and to determine the maximal tolerated dose (MTD) in this patient population. SECONDARY OBJECTIVES: I. To investigate possible pharmacokinetic interactions between cabozantinib and antiretroviral therapy in persons with HIV infection. II. To investigate the effects of therapy on participant immune status and HIV viral load. III. To preliminarily assess objective response rates associated with treatment for commonly represented tumors. OUTLINE: This is a dose-escalation study. Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UC San Diego Moores Cancer Center, La Jolla, California, United States
UCLA Center for Clinical AIDS Research and Education, Los Angeles, California, United States
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
UC San Diego Medical Center - Hillcrest, San Diego, California, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Louisiana State University, Lafayette, Louisiana, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Boston Medical Center, Boston, Massachusetts, United States
Siteman Cancer Center at Washington University, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Montefiore Medical Center-Einstein Campus, Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital, Bronx, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Thomas Street Clinic, Houston, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
Ben Taub General Hospital, Houston, Texas, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Harborview Medical Center, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Contact Details
Name: Missak Haigentz
Affiliation: AIDS Malignancy Consortium
Role: PRINCIPAL_INVESTIGATOR
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