Decitabine/Cedazuridine (INQOVI), an Oral DNA Demethylating Agent, in Subjects With BAP1 Cancer Predisposition Syndrome and Subclinical, Early-Stage Mesothelioma

Phase 2 Suspended 9 enrolled National Cancer Institute (NCI)

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a Phase II study to determine the rate of stabilization or disease improvement from investigational decitabine/cedazuridine (INQOVI) treatment in subjects with BRCA1-Associated Protein-1 (BAP1) Cancer Predisposition Syndrome (CPDS) and subclinical, early-stage mesothelioma. Progression-free survival (PFS) will also be determined for treated subjects, and the treatment safety (toxicity) evaluated....

Timeline

Start: 2024-01-31
Primary completion: 2026-12-01
Completion: 2027-12-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cedazuridine	Small molecule	100 mg	Oral
Subject	Decitabine	Small molecule	35 mg	Oral

Decitabine/Cedazuridine (INQOVI), an Oral DNA Demethylating Agent, in Subjects With BAP1 Cancer Predisposition Syndrome and Subclinical, Early-Stage Mesothelioma

Summary

Timeline

Drugs

Indications