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

Name: Decitabine/Cedazuridine (INQOVI), an Oral DNA Demethylating Agent, in Subjects With BAP1 Cancer Predisposition Syndrome and Subclinical, Early-Stage Mesothelioma — clinical trial record (NCT05960773)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 2

SponsorNational Cancer Institute (NCI)

Started2024-01-31

View on ClinicalTrials.gov ↗

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....

Amendment history 4 changes detected by DataLookout

2026-09-04

Recruitment resumed after suspension

2026-09-04

Enrollment increased: 9 → 15 participants

2026-09-04

Primary completion pushed: 2026-12-01 → 2028-07-01

2026-09-04

Completion pushed: 2027-12-01 → 2029-07-01

Trial Details

NCT Number	NCT05960773
Lead Sponsor	National Cancer Institute (NCI)
Conditions	Mesothelioma, Malignant Mesothelioma (MM), Early-stage Mesothelioma, Subclinical Mesothelioma, BRCA1-Associated Protein-1 (BAP1) Mutations, Early-stage BAP1-associated Malignancies
Enrollment	15 participants
Start Date	2024-01-31
Primary Completion	2028-07-01 (estimated)
Study Completion	2029-07-01 (estimated)
Updated on ClinicalTrials.gov	2026-09-03