Cabozantinib S-Malate in Treating Patients With Advanced Solid Tumors and Human Immunodeficiency Virus

Conditions

• Advanced Malignant Solid Neoplasm
• HIV Infection
• Metastatic Malignant Solid Neoplasm
• Recurrent Malignant Solid Neoplasm
• Unresectable Solid Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cabozantinib S-malate — DRUG
  Given PO
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Pharmacological Study — OTHER
  Correlative studies

Study Details

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.

Key Dates

Start date

Jun 21, 2013

Status verified

Dec 2022

Primary completion

May 22, 2019

Completion

May 12, 2021

Study Design

Enrollment

36 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Stratum A Treatment (cabozantinib s-malate): 20 mg/day
  Patients receive cabozantinib s-malate 20 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. This arm includes patients who are on ritonavir-boosted or cobicistat-boosted antiretroviral regimens
• Experimental: Stratum A Treatment (cabozantinib s-malate): 40 mg/day
  Patients receive cabozantinib s-malate 40 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. This arm includes patients who are on ritonavir-boosted or cobicistat-boosted antiretroviral regimens
• Experimental: Stratum A Treatment (cabozantinib s-malate): 60 mg/day
  Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. This arm includes patients who are on ritonavir-boosted or cobicistat-boosted antiretroviral regimens
• Experimental: Stratum B Treatment (cabozantinib s-malate): 60 mg/day
  Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. This arm includes patients who are on efavirenz or etravirine-based antiretroviral regimens
• Experimental: Stratum B Treatment (cabozantinib s-malate): 100 mg/day
  Patients receive cabozantinib s-malate 100 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. This arm includes patients who are on efavirenz or etravirine-based antiretroviral regimens
• Experimental: Stratum C Treatment (cabozantinib s-malate): 60 mg/day
  Patients receive cabozantinib s-malate 60 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. This arm includes patients who are on antiretroviral regimens that do not include the agents specified on stratum A or B, or who are not on antiretroviral therapy

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: Up to 30 days after completion of study treatment. Study treatment was between 1 and 82 weeks. ]

Locations (20)

Find similar trials in La Jolla, CA

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