Phase II Study of Nirogacestat in Patients With Kaposi Sarcoma
AIDS Malignancy Consortium
Summary
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.
Description
PRIMARY OBJECTIVE: I. Evaluate the efficacy of nirogacestat in terms of overall response (partial response \[PR\]) or complete response \[CR\]) of Kaposi sarcoma (KS) tumors. SECONDARY OBJECTIVES: I. Evaluate the safety and tolerability of nirogacestat. II. Evaluate the duration of response of KS tumors to nirogacestat. III. Assess the effect of nirogacestat on blood biomarkers such as CD4+ and CD8+ T, CD19+, cell number, human immunodeficiency virus (HIV) and Kaposi sarcoma-associated herpesvirus (KSHV) virus load. IV. Assess baseline levels of Notch target and regulatory gene products as…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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/m…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood
- ProcedureChest Radiography
Undergo chest X-ray
- ProcedureComputed Tomography
Undergo CT
- DrugNirogacestat
Given PO
- ProcedureSkin Biopsy
Undergo skin biopsy
Location
- Siteman Cancer Center at Washington UniversitySt Louis, Missouri