Nirogacestat in Patients With Kaposi Sarcoma (NCT07539454) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Nirogacestat in Patients With Kaposi Sarcoma
United States28 participantsStarted 2026-09-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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/mm\^3 (within three months prior to study entry)
* Platelet count ≥ 100,000/mm\^3 (within three months prior to study entry)
* Calculated (method of Cockcroft-Gault) creatinine clearance (CrCl) ≥ 60 mL/min (within three months prior to study entry) (CrCl may also be obtained by the 24-hour collection method at the investigator's discretion)
* Total bilirubin should be ≤ 1.5x upper limit of normal (ULN) (within three months prior to study entry). If, however, the elevated bilirubin is felt to be secondary to atazanavir therapy, patients will be allowed to enroll on protocol if the total bilirubin is ≤ 3.5 mg/dL provided that the direct bilirubin is normal
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) ≤ 3x ULN (within three months prior to study entry)
* Life expectancy…
What they're measuring
1
Overall response rate (ORR)
Timeframe: Up to 5 years after completion of study treatment