Trials / Completed
CompletedNCT01822522
Cabozantinib S-Malate in Treating Patients With Advanced Solid Tumors and Human Immunodeficiency Virus
Phase I Trial of Cabozantinib (XL184) for Advanced Solid Tumors in Persons With HIV Infection
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Advanced Malignant Solid Neoplasm
- HIV Infection
- Metastatic Malignant Solid Neoplasm
- Recurrent Malignant Solid Neoplasm
- Unresectable Solid Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cabozantinib S-malate | Given PO |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| OTHER | Pharmacological Study | Correlative studies |
Timeline
- Start date
- 2013-06-21
- Primary completion
- 2019-05-22
- Completion
- 2021-05-12
- First posted
- 2013-04-02
- Last updated
- 2023-01-10
- Results posted
- 2023-01-10
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01822522. Inclusion in this directory is not an endorsement.