Decitabine/Cedazuridine (INQOVI), an Oral DNA Demethylating Agent, in Subjects With BAP1 Cancer Predisposition Syndrome and Subclinical, Early-Stage Mesothelioma
Phase II Evaluation of Decitabine/Cedazuridine (INQOVI), an Oral DNA Demethylating Agent in Subjects With BAP1 Cancer Predisposition Syndrome and Subclinical, Early-Stage Mesothelioma
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 120 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether decitabine/cedazuridine (INQOVI), a medicine taken by mouth, can keep early mesothelioma stable or improve it. It is for adults with an inherited BAP1 gene change that raises cancer risk and very early mesothelioma, a cancer of the tissue lining some organs. The study also checks safety and how long the cancer stays from getting worse.
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....
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, with an inherited BAP1 gene change and very early mesothelioma confirmed by a tissue test.
- Have cancer too limited to need standard first treatment. Some people with early tumors may qualify if they were offered and refused that treatment. Other early BAP1-related cancers are allowed.
- Have cancer that can be checked with a small camera placed in the chest or belly within 8 weeks before treatment. Agree to these checks before and after treatment.
- Agree to join related study 20C0106 and/or 06C0014 so researchers can collect and study tissue and blood samples.
- Be fully active or able to do light work. Meet the study’s lung, blood oxygen, blood cell, blood clotting, liver, and kidney test requirements.
- If able to become pregnant, use effective birth control during the study and for 6 months after the last dose. If able to father a child, use it during the study and for 3 months after the last dose.
- If nursing or breastfeeding, agree to stop from the start of treatment until 2 weeks after the last dose.
- Be able to understand the study and agree to sign a consent form.
Who can't join
- Have cancer that needs standard first treatment.
- Have had a stroke or heart attack within 6 months, or have serious heart disease, heart rhythm problems, bleeding, or a blood clot in the lungs.
- Have used blood thinners to treat or prevent clots within 2 weeks before treatment.
- Have active hepatitis A, B, or C, a history of HIV or an AIDS-related illness, active COVID, or another active infection needing medicine that works throughout the body.
- Have had major surgery within 4 weeks before treatment.
- Have used medicines that weaken the immune system within 4 weeks before treatment, except steroids that do not act throughout the body.
- Have previously received a DNA demethylating drug, the type of cancer medicine being tested.
- Are pregnant, or have an uncontrolled illness or other situation that would make it hard to follow study requirements.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
* INCLUSION CRITERIA: * 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 are 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) performed at screening (within 8 weeks prior to treatment initiation). * 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 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. * Individuals of child-bearing potential (IOCBP) and those that can father children 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 (IOCBP) or 3 months (those that can father children) after the last dose of the decitabine/cedazuridine. * Nursing (including breastfeeding) participants must be willing to discontinue nursing 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. EXCLUSION CRITERIA: * 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 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. * Major surgery within 4 weeks prior to study treatment initiation. * 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 IOCBP at screening). * Uncontrolled intercurrent illness or situation that would limit compliance with study requirements.
Study sites (1)
MD
- National Institutes of Health Clinical Center · Bethesda, MD 20892National Cancer Institute Referral Office · Study contact · 888-624-1937More trials in Bethesda