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Proteasome Inhibitor

Ixazomib for Kaposi Sarcoma

Phase 2

Recruiting

Led By Ronald T Mitsuyasu

Research Sponsored by AIDS Malignancy Consortium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)

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

Must not have

Participants who have had prior treatment of Kaposi sarcoma with a proteasome inhibitor within the last 2 years or with ixazomib at any time

Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 weeks post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how well ixazomib works to treat patients with Kaposi sarcoma by blocking enzymes needed for cell growth.

Who is the study for?

Adults with Kaposi sarcoma, good performance status (able to carry out daily activities), and adequate organ function can join. They must have measurable skin lesions, not be pregnant or breastfeeding, use contraception if of childbearing potential, and have a life expectancy over 3 months. HIV-positive patients need stable antiretroviral therapy for at least 4 weeks.

What is being tested?

The trial is testing Ixazomib's effectiveness on Kaposi sarcoma by seeing if it can stop tumor growth. It involves taking the drug orally and monitoring its impact through health questionnaires and assessments.

What are the potential side effects?

Ixazomib may cause side effects like fatigue, digestive issues, rash or other skin reactions, blood disorders such as low platelet counts or anemia, nerve damage leading to pain or numbness in limbs (peripheral neuropathy), and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I can do most of my daily activities but might need help.

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I have at least five visible skin lesions or one large lesion covering 700 mm^2.

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My skin cancer has been confirmed as Kaposi sarcoma through a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken proteasome inhibitors for Kaposi sarcoma in the last 2 years, nor have I ever taken ixazomib.

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I have a stomach or intestine condition that affects how I absorb pills or makes it hard for me to swallow.

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I am not taking any strong medication that affects liver enzymes or St. John's wort.

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I am not pregnant or breastfeeding.

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I don't have another cancer that could affect this treatment's safety or results.

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I have recovered from side effects of previous cancer treatments, except for hair loss.

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I have severe nerve pain in my hands or feet.

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I have hepatitis C without cirrhosis and my liver function tests meet the study's criteria.

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I have not had major surgery in the last 14 days.

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I have Kaposi sarcoma that is causing symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 weeks post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 weeks post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate

Secondary study objectives

Change in CD4 counts

Change in Kaposi-sarcoma associated herpes virus (KSHV) viral load (VL)

Change in human immunodeficiency virus (HIV) VL

+2 more

Other study objectives

Change in quality of life

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ixazomib)Experimental Treatment3 Interventions

Patients receive ixazomib PO on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response may continue treatment for an additional 12 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ixazomib Citrate

2012

Completed Phase 3

~970

0 / 13Eligibility criteria met