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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05960773
Phase
PHASE2
Status
Recruiting
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Conditions

  • BRCA1-Associated Protein-1 (BAP1) Mutations
  • Early-stage BAP1-associated Malignancies
  • Early-stage Mesothelioma
  • Malignant Mesothelioma (MM)
  • Mesothelioma
  • Subclinical Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Decitabine/cedazuridine — DRUG
    Decitabine/cedazuridine (INQOVI) oral tablet (35 mg decitabine and 100 mg cedazuridine) taken 3 consecutive days during the first week of every cycle (1 cycle=28-days) for 6 cycles (i.e., 1 course). Additional 6 cycles (i.e., Course 2) for subjects with stable disease or disease regression. Max (total) of 2 treatment courses.

Study Details

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....

Key Dates

First listed
Jul 27, 2023
Start date
Jan 31, 2024
Status verified
Sep 2026
Primary completion
Jul 1, 2028
Completion
Jul 1, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1/ Arm 1
    Decitabine/cedazuridine (35 mg decitabine and 100 mg cedazuridine; PO QD)

Primary Outcome Measure

To determine stabilization or disease improvement rates in participants with early-stage mesotheliomas arising in the context of BAP1 CPDS following decitabine/cedazuridine treatment [ Time Frame: baseline, before each cycle, after every 6 treatment cycles (Course 1 and Course 2), and at the safety visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
National Cancer Institute Referral Office
888-624-1937

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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