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Anti-metabolites

Oral DNA Demethylating Agent for Mesothelioma

Phase 2
Recruiting
Led By David S Schrump, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate pulmonary reserve evidenced by FEV1 and DLCO >= 35% predicted on screening pulmonary function testing (PFTs)
Histologically confirmed by NCI LP subclinical, early-stage (Tx-T1) mesotheliomas
Must not have
History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before each cycle, after every 6 treatment cycles (course 1 and course 2), and at the safety visit
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug to treat BAP1 CPDS and early-stage mesothelioma. It will measure safety, progression-free survival, and stability/improvement.

Who is the study for?
This trial is for adults with BAP1 Cancer Predisposition Syndrome and early-stage mesothelioma who haven't received certain treatments. They must be able to perform daily activities with minimal assistance, agree to use contraception, and undergo specific procedures to assess treatment response. Excluded are those with recent significant cardiovascular events, active infections like COVID or hepatitis, HIV/AIDS-related illness, pregnancy, or on immunosuppressants.
What is being tested?
The study tests the effectiveness of an oral medication called INQOVI (decitabine/cedazuridine) in stabilizing or improving subclinical mesothelioma in patients predisposed due to BAP1 mutations. It measures how long patients live without disease progression and evaluates the safety of this treatment.
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of decitabine/cedazuridine may include fatigue, nausea, low blood cell counts leading to increased infection risk or bleeding problems. Specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung function tests show I have enough breathing capacity.
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My mesothelioma is in an early stage and confirmed by a biopsy.
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My cancer is not extensive enough for standard treatments like surgery or chemotherapy.
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I am fully active or can carry out light work.
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I am 18 years old or older.
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My disease was confirmed through a minimally invasive video procedure.
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I have a genetic mutation in the BAP1 gene.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of HIV or AIDS-related illness.
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I haven't had a stroke, heart attack, severe chest pain, serious heart failure, dangerous irregular heartbeat, significant bleeding, or a serious blood clot in the lungs in the last 6 months.
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I currently have COVID-19.
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I haven't taken immune-weakening medications in the last 4 weeks, except for non-systemic corticosteroids.
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I am currently being treated for an active infection.
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I have been treated with a drug that changes DNA activity before.
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I have not taken blood thinners in the last 2 weeks.
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My cancer needs immediate standard treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before each cycle, after every 6 treatment cycles (course 1 and course 2), and at the safety visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and before each cycle, after every 6 treatment cycles (course 1 and course 2), and at the safety visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To determine stabilization or disease improvement rates in participants with early-stage mesotheliomas arising in the context of BAP1 CPDS following decitabine/cedazuridine treatment
Secondary study objectives
To determine PFS in participants receiving decitabine/cedazuridine
To evaluate the safety of decitabine/cedazuridine

Side effects data

From 2022 Phase 3 trial • 727 Patients • NCT02085408
94%
White blood cell decreased
93%
Platelet count decreased
89%
Neutrophil count decreased
89%
Anemia
26%
Aspartate aminotransferase increased
22%
Alanine aminotransferase increased
19%
Creatinine increased
17%
Blood bilirubin increased
13%
Alkaline phosphatase increased
11%
Hypomagnesemia
9%
Febrile neutropenia
7%
Lymphocyte count decreased
4%
Lung infection
4%
Fatigue
4%
Hyperglycemia
4%
Urinary tract infection
4%
Diarrhea
2%
Investigations - Other, specify
2%
Colitis
2%
Hypoxia
2%
Dyspnea
2%
Pneumonitis
2%
Infections and infestations - Other
2%
Hyponatremia
2%
Pharyngitis
2%
Hypokalemia
2%
Generalized muscle weakness
2%
Skin infection
2%
Eye disorders - Other, specify
2%
Leukocytosis
2%
Thromboembolic event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm F (Maintenance: Decitabine)
Arm B (Induction: Clofarabine)
Arm A (Induction: Daunorubicin + Cytarabine)
Arm C (Consolidation: Cytarabine)
Arm D (Consolidation: Clofarabine)
Arm E (Maintenance: Observation)
Arm G (Transplant)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1/ Arm 1Experimental Treatment1 Intervention
Decitabine/cedazuridine (35 mg decitabine and 100 mg cedazuridine; PO QD)

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,956 Previous Clinical Trials
41,112,187 Total Patients Enrolled
94 Trials studying Mesothelioma
8,616 Patients Enrolled for Mesothelioma
David S Schrump, M.D.Principal InvestigatorNational Cancer Institute (NCI)
20 Previous Clinical Trials
2,234 Total Patients Enrolled
11 Trials studying Mesothelioma
2,054 Patients Enrolled for Mesothelioma

Media Library

Decitabine/Cedazuridine (INQOVI) (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05960773 — Phase 2
Mesothelioma Research Study Groups: 1/ Arm 1
Mesothelioma Clinical Trial 2023: Decitabine/Cedazuridine (INQOVI) Highlights & Side Effects. Trial Name: NCT05960773 — Phase 2
Decitabine/Cedazuridine (INQOVI) (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05960773 — Phase 2
~7 spots leftby Dec 2025
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