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Tyrosine Kinase Inhibitor

Pharmacological Study for Cancer

Phase 1
Waitlist Available
Led By Missak Haigentz
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have known HIV infection and histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; any number of prior cancer therapies will be permitted; at least 4 weeks must have elapsed since prior chemotherapy or biological therapy, 6 weeks if the regimen included carmustine (BCNU) or mitomycin C; prior radiation therapy to the thoracic cavity, abdomen, or pelvis must be completed at least 3 months prior to registration; radiotherapy to any other site (including bone or brain metastases) must be completed at least 28 days prior to registration
Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), positive western blot, or any other federally approved licensed HIV test; alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and western blot, or other approved diagnostic tests
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days after treatment initiation
Awards & highlights

Study Summary

This trial is testing the effects of cabozantinib s-malate on patients with solid tumors that have spread and usually can't be cured or controlled. Cabozantinib s-malate may stop tumor cell growth by blocking some enzymes needed for cell growth.

Eligible Conditions
  • Cancer
  • Solid Tumors
  • HIV/AIDS

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days after treatment initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days after treatment initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events
Maximal Tolerated Dose (MTD) of Cabozantinib-s-malate
Secondary outcome measures
CD4+ Cell Counts
CD8+ Cell Counts
Human Immunodeficiency Virus (HIV) Viral Load
+2 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Stratum C Treatment (cabozantinib s-malate): 60 mg/dayExperimental Treatment3 Interventions
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
Group II: Stratum B Treatment (cabozantinib s-malate): 60 mg/dayExperimental Treatment3 Interventions
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
Group III: Stratum B Treatment (cabozantinib s-malate): 100 mg/dayExperimental Treatment3 Interventions
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
Group IV: Stratum A Treatment (cabozantinib s-malate): 60 mg/dayExperimental Treatment3 Interventions
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
Group V: Stratum A Treatment (cabozantinib s-malate): 40 mg/dayExperimental Treatment3 Interventions
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
Group VI: Stratum A Treatment (cabozantinib s-malate): 20 mg/dayExperimental Treatment3 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib S-malate
2013
Completed Phase 2
~470

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,606 Previous Clinical Trials
40,913,448 Total Patients Enrolled
Missak HaigentzPrincipal InvestigatorAIDS Malignancy Consortium
3 Previous Clinical Trials
79 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a multitude of hospitals currently engaging in this research endeavor within Canada?

"UCLA Center for Clinical AIDS Research and Education in Los Angeles, California, Montefiore Medical Center-Einstein Campus in Bronx, New york, Ben Taub General Hospital in La Jolla, Ohio as well as 21 other medical centres are currently accepting participants for this clinical trial."

Answered by AI

What is the main aim of this medical research?

"The primary end-point of this clinical trial, which will be measured over a timeline spanning up to 4 weeks, is the incidence of adverse events. Secondary outcomes include CD8+ cell count (which will use a repeated measures analysis - or Friedman's test in cases where data does not meet assumptions of normality), response rates (binomial proportions and 95% confidence intervals) and effects on HIV viral load (again using either a repeated measures analysis or Friedman's test)."

Answered by AI

Has Cabozantinib S-malate obtained authorization from the FDA?

"Cabozantinib S-malate's safety is rated a 1 on our scale, as this trial has just reached Phase 1 and thus only contains limited data about its efficacy and safety."

Answered by AI

How many participants can join this investigation?

"This trial is no longer in need of participants, as its last edit was made on 6/28/2022. If you are searching for other studies that may be a fit for your needs, there are currently 3708 clinical trials accepting patients with solid neoplasms and 109 trials involving Cabozantinib S-malate actively recruiting."

Answered by AI

Has Cabozantinib S-malate been the subject of prior research projects?

"Cabozantinib S-malate was initially trialled in 2012 by Memorial Sloan Kettering Commack. So far, 643 clinical studies have been completed on the medication with 109 still ongoing, predominantly concentrated around Los Angeles, California."

Answered by AI

What ailments does Cabozantinib S-malate typically provide relief to?

"Cabozantinib S-malate may be effective in treating advanced renal cell carcinoma (ARCC), adrenal medulla, and other conditions that have resisted anti-VEGF treatments."

Answered by AI

Are there any open slots to join this clinical trial?

"According to clinicaltrials.gov, this specific trial is not actively recruiting patients at present and has been last updated on June 28th 2022 after initially being posted in 2013. Nevertheless, a vast 3817 medical studies are still enrolling participants right now."

Answered by AI

Does this research break new ground in its field?

"Currently, there are 109 running clinical trials related to Cabozantinib S-malate being conducted in 1315 cities and 45 countries. This drug was first trialled in 2012 by Exelixis with a sample size of 86 participants. Since then, 643 more studies have been completed, the most recent reaching Phase 2 approval status."

Answered by AI
~3 spots leftby Mar 2025