NCT04305691 · AIDS Malignancy Consortium
Trial of Ixazomib for Kaposi Sarcoma
What this study is about
This phase II trial studies how well ixazomib works in treating patients with Kaposi sarcoma. Ixazomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
View original scientific description
This phase II trial studies how well ixazomib works in treating patients with Kaposi sarcoma. Ixazomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Interventions
DRUG
Ixazomib Citrate
Given PO
OTHER
Quality-of-Life Assessment
Ancillary studies
OTHER
Questionnaire Administration
Ancillary studies
Primary outcome measures
Overall response rate
Time frame: Up to 4 weeks post treatment
The binomial proportion and its 90% one-sided confidence interval will be used to estimate the overall response rate. Response and progression will be evaluated in this study using the acquired Immunodeficiency syndrome (AIDS) Clinical Trials Groups (ACTG) response criteria for Kaposi sarcoma, as outlined in the AIDS Malignancy Consortium (AMC) Kaposi sarcoma Response Evaluation Manual of Procedures (MOP).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Ability to understand and the willingness to sign a written informed consent document
- Participants must have histologically or cytologically confirmed cutaneous Kaposi sarcoma. Participants must have measurable disease with a minimum of five bi-dimensionally measurable KS cutaneous marker lesions. If fewer than five bi-dimensionally measurable marker lesions are available, the total surface area of the marker lesion(s) must be \>= 700 mm\^2
- Participants must have documentation of HIV status. If HIV negative, documentation of a negative HIV rapid test within 21 days before enrollment. If HIV positive, documentation of HIV-1 infection by means of any one of the following:
- Documentation of HIV diagnosis in the medical record by a licensed health care provider
- Documentation of receipt of antiretroviral therapy (ART) (at least two different medications that do not constitute a prescription for pre exposure prophylaxis \[PrEP\]) by a licensed health care p
Where
- San Diego, California
- San Francisco, California
- Miami, Florida
- Chicago, Illinois
- Baltimore, Maryland
- St Louis, Missouri
- New York, New York
- Philadelphia, Pennsylvania
- Houston, Texas
- Seattle, Washington
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations