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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before each cycle, after every 6 treatment cycles (course 1 and course 2), and at the safety visit
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
To determine PFS in participants receiving decitabine/cedazuridine
To evaluate the safety of decitabine/cedazuridine
Side effects data
From 2022 Phase 2 trial • 14 Patients • NCT0405584457%
Febrile neutropenia
57%
Neutrophil count decreased
21%
Infections and infestations - Other, specify
21%
Lung infection
21%
Bacteremia
21%
Sepsis
14%
Aspartate aminotransferase increased
14%
Alanine aminotransferase increased
14%
Infections and infestations - Other,
7%
Mucositis oral
7%
White blood cell decreased
7%
Syncope
7%
Upper gastrointestinal
7%
Sinusitis
7%
Hyperglycemia
7%
Hypertension
7%
Encephalopathy
7%
Hepatobiliary disorders
7%
Blood and lymphatic system
7%
General disorders and administration
7%
INR increased
7%
Typhlitis
7%
Upper gastrointestinal hemorrhage
7%
Hepatic failure
7%
Injury, poisoning and procedural
7%
Blood and lymphatic system disorders - Other, specify
7%
Fatigue
7%
Intracranial hemorrhage
7%
Gastrointestinal disorders - Other,
7%
Disease progression
7%
Fever
7%
Skin and subcutaneous tissue disorders - Other, specify
7%
Neoplasms benign, malignant and
7%
Alanine aminotransferase
7%
Tooth infection
7%
Gastrointestinal disorders - Other, specify
7%
Pericardial effusion
7%
General disorders and administration site conditions - Other, specify
7%
Hepatic infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Decitabine + Ruxolitinib + DLI
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
13,672 Previous Clinical Trials
40,926,426 Total Patients Enrolled
93 Trials studying Mesothelioma
8,639 Patients Enrolled for Mesothelioma
David S Schrump, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
2,209 Total Patients Enrolled
10 Trials studying Mesothelioma
2,039 Patients Enrolled for Mesothelioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung function tests show I have enough breathing capacity.I am breastfeeding but willing to stop from the start of the study until 2 weeks after the last dose.If you are a woman who could become pregnant, you have a positive pregnancy test.My mesothelioma is in an early stage and confirmed by a biopsy.Your oxygen levels are at least 92% when measured with a pulse oximeter or arterial blood gas test.I have a history of HIV or AIDS-related illness.I have early-stage BAP1-related cancer, possibly including mesothelioma.My cancer is not extensive enough for standard treatments like surgery or chemotherapy.I agree to join other studies for my condition as recommended.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.I currently have COVID-19.I am fully active or can carry out light work.I agree to use effective birth control during and up to 6 months after the study.I am willing to have minor surgeries to check how well the treatment is working.I haven't taken immune-weakening medications in the last 4 weeks, except for non-systemic corticosteroids.I am currently being treated for an active infection.I do not have any health issues that would stop me from following the study's requirements.I am 18 years old or older.My kidney, liver, and blood functions are all within normal ranges.I have been treated with a drug that changes DNA activity before.I have not taken blood thinners in the last 2 weeks.My cancer needs immediate standard treatment.You currently have Hepatitis A, Hepatitis B, or Hepatitis C.My disease was confirmed through a minimally invasive video procedure.I have a genetic mutation in the BAP1 gene.
Research Study Groups:
This trial has the following groups:- Group 1: 1/ Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment extend to elderly individuals in excess of 85 years old?
"The terms of inclusion for this medical study specify that the lowest age for participants is 18 and the highest limit is 120."
Answered by AI
What are the qualifications to participate in this clinical investigation?
"Applicants who have been diagnosed with mesothelioma and are aged between 18 and 120 years old may be eligible for participation in this clinical trial, which seeks to enrol 15 participants."
Answered by AI
Are there any openings remaining in this clinical trial?
"Per the records on clinicaltrials.gov, this experiment is not presently recruiting participants. The trial was first initiated on July 31st of 2023 and its last update was 25 days later. Despite that fact, 159 other studies are currently taking in candidates for their research projects."
Answered by AI
Has the FDA sanctioned 1/ Arm 1 for use?
"Our team at Power assigned a score of 2 to Arm 1 in terms of safety, as clinical data exists that supports its safeness but efficacy has yet to be established."
Answered by AI
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