Nirogacestat in Patients With Kaposi Sarcoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAIDS Malignancy Consortium
About this trial
This phase II trial studies how well nirogacestat works in treating patients with skin Kaposi sarcoma (KS). Several anti-cancer drugs work well in treating KS, but there is no treatment that cures KS. Nirogacestat binds to a protein called gamma secretase, which blocks the activation of other proteins called Notch receptors. Blocking these proteins may help keep tumor cells from growing and may kill them. Nirogacestat is a type of gamma secretase inhibitor. Nirogacestat may be effective in shrinking the size of KS lesions and reducing the spread of lesions.
Eligibility criteria
Qualifiers
Biopsy-proven KS involving skin with or without visceral involvement either newly diagnosed or refractory to or intolerant of one or more prior therapies.
Patients must have cutaneous lesion(s) amenable to six total biopsies (minimum size of biopsy to be 4 mm), either six lesions > 4 mm or one large lesion measuring 20 mm that can undergo serial biopsy, and at least five additional lesions measurable for assessment with no improvement over the past month.
Hemoglobin ≥ 8 g/dL (within three months prior to study entry)
Absolute neutrophil count (ANC) ≥ 1,000 cells/mm^3 (within three months prior to study entry)
Disqualifiers
Concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment.
Patients for whom front-line cytotoxic therapy is indicated (i.e., symptomatic visceral or pulmonary KS or symptomatic KS impairing functional status).
Concurrent neoplasia requiring cytotoxic therapy.
Anti-neoplastic treatment for KS (including chemotherapy, radiation therapy, local therapy including topical 5-FU, biological therapy, or investigational therapy) within four weeks of study entry.
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Chest Radiography
- Computed Tomography
- Nirogacestat
- Skin Biopsy
Treatment groups
28 Participants
are divided into 1 treatment groupSponsors and collaborators
AIDS Malignancy Consortium
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov