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New treatment option for Kaposi Sarcoma
Official title Trial of Ixazomib for Kaposi Sarcoma
ClinicalTrials.gov ID: NCT04305691
What this study is testing
What is Ixazomib Citrate?
Ixazomib Citrate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for kaposi sarcoma.
Also referred to as MLN-9708, MLN9708.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Participants must have documentation of HIV status. If HIV negative, documentation of a negative HIV rapid test within 21 days before enrollment. If...
- 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...
You likely can't join if
- Participants who are receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ixazomib or other agents used in study
- Chronic systemic treatment using strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; uncontrolled cardiovascular conditions, including...
- Participants with a second prior or concurrent malignancy that has a natural history or treatment regimen that has the potential to interfere with...
- Pregnant women are excluded from this study because ixazomib is expected to cause fetal harm if used during pregnancy. It is not known if ixazomib is...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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 provider. Documentation...
- HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating \> 1000 RNA copies/mL
- Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or Multispot HIV-1/HIV-2 Rapid Test or HIV Antibody...
- Note: The term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally (e.g., United States [U.S.] Food and Drug Administration...
- Eastern Cooperative Oncology Group (ECOG) performance status =\ = 50%)
- Life expectancy of greater than 3 months
- Absolute neutrophil count: \>= 1,000/mm\^3 (within 21 days before enrollment)
- Hemoglobin: \> 8 g/dL (within 21 days before enrollment)
- Platelets: \>= 75,000/mm\^3 (within 21 days before enrollment). Platelet transfusions to help participants meet eligibility criteria are not allowed within 3 days before study enrollment
- Total bilirubin =\< 1.5 x the upper limit of the normal range (ULN) (within 21 days before enrollment)
- If the elevated bilirubin is felt to be secondary to indinavir or atazanavir therapy, then people will be allowed on protocol without any limit on the total bilirubin if the direct bilirubin is normal
- Creatinine:
- Serum creatinine levels within normal institutional limits; or, creatinine clearance \>= 30 mL/min (as calculated per the Cockcroft-Gault Equation (within 21 days before enrollment)
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association...
- Ixazomib can cause fetal harm. For this reason and because proteasome inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to...
- If HIV positive, participants must have been on antiretroviral therapy (ART) with optimum anti-viral response for at least 12 weeks. Three-drug ART regimens which include a protease inhibitor or a nucleoside reverse...
- If HIV positive, must have been on a STABLE anti-retroviral therapy for at least 4 weeks. The non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz and etravirine are moderate CYP3A4 inducers which will...
- HIV positive participants must not show recent improvement in KS on ART alone that may confound response evaluation, within the following parameters:
- If on ART 12 to 24 weeks, participants must show a burden of disease requiring further systemic KS-directed treatment (i.e. advanced cutaneous disease, presence of lymphedema or asymptomatic visceral disease, painful...
- i.e. any new lesion(s);
- spreading of lesions by any measurable degree;
- development of ulceration;
- worsening edema documented by circumferential measure of limb or body;
- increase in symptoms such as pain, including negative psychological impact;
- any degree of disease worsening by imaging that would prompt expert assessment to recommend further systemic treatment with delay
- If on ART for \>24 weeks, must show no evidence of regression in last 8 weeks
- Patients who have residual active KS lesions (not merely tattoo effect) after receipt of recent KS-directed therapy are eligible to participate even if there was no interval progression since completion of therapy as...
What rules you out
- Participants who are receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ixazomib or other agents used in study
- Chronic systemic treatment using strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort is not allowed. Patients who are on chronic use of strong...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic...
- Participants with a second prior or concurrent malignancy that has a natural history or treatment regimen that has the potential to interfere with the safety or how well it works assessment of the investigational regimen
- Pregnant women are excluded from this study because ixazomib is expected to cause fetal harm if used during pregnancy. It is not known if ixazomib is excreted into breast milk, but due to the potential for serious...
- Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) before entering the study
- Participants who have not recovered from other adverse events due to prior anti-cancer therapy (i.e., have residual toxicity \> grade 1), excluding alopecia
- Participants who are seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). All participants will be required to be screened for hepatitis B. Participants with resolved...
- Participants diagnosed with hepatitis C who are hepatitis C antibody positive, whether hepatitis C RNA level is measurable or not, must have no evidence of cirrhosis and have liver function tests that conform to the...
- Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
- Participants with grade 2 or higher peripheral neuropathy (i.e., painful neuropathy) on clinical examination during the screening period
- Major surgery within 14 days before enrollment
- Participants with symptomatic visceral Kaposi sarcoma
- Participants who have had prior treatment of Kaposi sarcoma with a proteasome inhibitor within the last 2 years or with ixazomib at any time.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- San Francisco, California, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; San Francisco, California, United States; Miami, Florida, United States; Chicago, Illinois, United States; Baltimore, Maryland, United States; St Louis, Missouri, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.