Study on Oral Treatment INQOVI for Patients with BAP1 Cancer Predisposition Syndrome and Early-Stage Mesothelioma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05960773

Provider View

This clinical trial is testing the effectiveness and safety of an oral medication called INQOVI in patients with a genetic condition that increases their risk of developing mesothelioma, a type of cancer. The study aims to see if the treatment can stabilize or improve the disease in its early stages.

Patient Parameters

Program Overview

This Phase II study is exploring whether the oral medication INQOVI can help stabilize or improve early-stage mesothelioma in patients with a genetic condition known as BAP1 Cancer Predisposition Syndrome. The study will also assess how long patients can live without the disease getting worse and evaluate the safety of the treatment.

Description

This study focuses on patients with a genetic mutation in the BRCA1-Associated Protein-1 (BAP1) gene, which increases the risk of developing mesothelioma and other cancers. Mesothelioma is a cancer that affects the lining of the lungs and other organs. The study is testing an oral medication called INQOVI, which is already approved for other conditions, to see if it can help control early-stage mesothelioma in these patients.

Participants will take INQOVI in capsule form for three days each month over a six-month period. The study will involve regular imaging tests and minimally invasive procedures to monitor the disease and collect tissue samples. If the disease remains stable or improves, participants may continue treatment for an additional six months.

The study will include about 13 participants who meet specific criteria, such as having a confirmed BAP1 mutation and early-stage mesothelioma. Participants must be in good overall health and willing to undergo certain medical procedures as part of the study. The study will also evaluate the safety of the treatment and any side effects that may occur.

Eligibility Criteria

Inclusion Criteria

  • Have a history of a genetic mutation in the BAP1 gene.
  • Have early-stage mesothelioma confirmed by medical tests.
  • May have other early-stage cancers associated with BAP1.
  • The disease must not be severe enough to require standard treatments like surgery or chemotherapy.
  • Be 18 years or older.
  • Have disease that can be evaluated through minimally invasive procedures.
  • Be willing to undergo medical procedures before and after treatment to assess response.
  • Be willing to participate in related studies for additional testing.
  • Have a good performance status, meaning able to carry out daily activities.
  • Have adequate lung function and oxygen levels.
  • Have normal blood cell counts and organ function based on specific tests.
  • Agree to use effective birth control during and after the study if of childbearing potential.
  • Be willing to stop breastfeeding during and after the study if applicable.
  • Be able to understand and sign a consent form.

Exclusion Criteria

  • Have cancers that require standard treatment.
  • Have significant heart or blood vessel disease, such as recent stroke or heart attack.
  • Be on blood thinners within two weeks before starting the study.
  • Have active hepatitis A, B, or C infections.
  • Have a history of HIV or AIDS-related illness.
  • Have other active infections needing treatment.
  • Have an active COVID-19 infection.
  • Have had major surgery within four weeks before starting the study.
  • Be on immunosuppressive medications within four weeks before starting the study, except for certain steroids.
  • Have been treated with a similar type of medication before.
  • Be pregnant or planning to become pregnant during the study.
  • Have any other serious illness that would interfere with the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.