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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required


Population Exclusion(s)

Pregnant Women;


BRCA1-Associated Protein-1;
DNA methyltransferases (DNMT);
ring finger domains 1 (UHRF1);
germline antigens;
peripheral immune subsets

Recruitment Keyword(s)



Malignant mesothelioma (MM);
early-stage mesothelioma;
subclinical mesothelioma;
BRCA1-Associated Protein-1 (BAP1) mutations;
early-stage BAP1-associated malignancies

Investigational Drug(s)

Decitabine/cedazuridine (INQOVI)

Investigational Device(s)



Drug: Decitabine/cedazuridine

Supporting Site

National Cancer Institute

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.

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- Participants with history of germline BRCA1-Associated Protein-1 (BAP1) mutations.

- Histologically confirmed by NCI LP subclinical, early-stage (Tx-T1) mesotheliomas.

- Participants with other early-stage BAP1-associated malignancies in addition to subclinical, early-stage mesotheliomas may be eligible for study.

- The extent of the disease (Tx by radiographic imaging) must be insufficient to warrant approved front-line therapies (surgery, chemotherapy, immunotherapy) per standard of care (SOC). Participants with cT1 tumors may be eligible for study if they have been offered and have refused front-line SOC treatment.

- Age >= 18 years.

- Evaluable disease as confirmed by minimally invasive (videoscopic) assessment (thoracoscopy and/or laparoscopy).

- Willingness to undergo pre- and post-treatment minimally invasive thoracoscopy and/or laparoscopy to assess treatment response.

- Willingness to co-enroll on 20C0106 (Prospective Evaluation of High Resolution Dual Energy Computed Tomographic Imaging, Noninvasive (Liquid) Biopsies, and Minimally Invasive Surgical Surveillance for Early Detection of Mesotheliomas in Patients with BAP1 Tumor Predisposition Syndrome) and/or 06C0014 (Prospective Evaluation of Genetic and Epigenetic Alterations in Patients with Thoracic Malignancies) to enable collection/processing of tumor, blood and normal pleura if applicable per PI.

- ECOG performance status 0 - 1

- Adequate pulmonary reserve evidenced by FEV1 and DLCO >= 35% predicted on screening pulmonary function testing (PFTs).

- Oxygen saturation >= 92% on room air by pulse oximetry or >= 92% by arterial blood gas (ABG) (ABG to be drawn if pulse oximetry < 90% on room air) at screening.

- Adequate renal, hepatic, and hematopoietic function at screening as defined below:

--leukocytes >= 3,000/microL

--absolute neutrophil count >= 1,500/microL (without transfusion or cytokine support within 2 months prior to study treatment initiation)

--absolute lymphocyte count > 800/microL

--platelets >=100,000/microL and < 1,200,000/microL

--prothrombin time (PT) <=2 seconds above the upper limit of normal (ULN)

--total bilirubin < 1.5 X institutional upper limit of normal OR direct bilirubin <= 1 ULN for participants with total bilirubin > 1.5 ULN

--serum albumin >= 2.0 mg/dL

--aspartate aminotransferase (AST) / alanine aminotransferase (ALT) <= 2.5 X institutional ULN

-- creatinine <= 1.6 mg/ml OR creatinine clearance (eGFR) >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal.

- Women of child-bearing potential (WOCBP) and men must agree to use an effective method of contraception (barrier, hormonal, intrauterine device (IUD), surgical sterilization) from the study entry and up to 6 months (women) or 3 months (men) after the last dose of the decitabine/cedazuridine.

- Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 2 weeks after the last dose of the study drug.

- The ability of a participant to understand and the willingness to sign a written informed

consent document.


- Participants with cancers requiring frontline standard of care treatment.

- Clinically significant cardiovascular/cerebrovascular disease as follows: cerebral vascular accident/stroke (< 6 months prior to study treatment initiation), myocardial infarction (< 6 months prior to study treatment initiation), unstable angina, congestive heart failure (New York Heart Association Classification Class >= II, serious cardiac arrhythmia, clinically significant bleeding or clinically significant pulmonary embolism.

- Therapeutic anticoagulation (oral agents and Lovenox, etc., are monitored by factor 10 levels, not PT or partial thromboplastin time (PTT)) within 2 weeks prior to study treatment initiation.

- Active Hepatitis A (HAV), Hepatitis B (HBV) (e.g., HBsAg reactive), or Hepatitis C (HCV) (e.g., HCV RNA [qualitative] is detected) at screening.

- History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness.

- Other active infections requiring systemic therapy.

- Active COVID infection.

- Immunosuppressive medications within 4 weeks prior to study treatment initiation except non-systemic corticosteroids.

- History of prior treatment with a DNA demethylating agent.

- Pregnancy (confirmed with beta human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening).

- Uncontrolled intercurrent illness or situation that would limit compliance with study requirements.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

David S. Schrump, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-3942
(240) 760-6239

Deneise Francis, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N222
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3974

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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