Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
42

Summary

Conditions
  • Advanced Malignant Solid Neoplasm
  • HIV Infection
  • Metastatic Malignant Solid Neoplasm
  • Recurrent Malignant Solid Neoplasm
  • Unresectable Solid Neoplasm
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 OBJE...

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.

Tracking Information

NCT #
NCT01822522
Collaborators
Not Provided
Investigators
Principal Investigator: Missak Haigentz AIDS Malignancy Consortium