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Study on Talazoparib for Maintenance Treatment in Patients with Advanced Malignant Pleural or Peritoneal Mesothelioma After Initial Chemotherapy

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What is this study about?

This clinical trial is focused on studying a type of cancer called mesothelioma, which affects the lining of the lungs or abdomen. Specifically, it looks at two forms: pleural mesothelioma, which occurs in the chest area, and peritoneal mesothelioma, which occurs in the abdominal area. The study is testing a treatment called Talazoparib, which is taken as a capsule. This treatment is being used after patients have already received a type of chemotherapy that includes platinum-based drugs.

The purpose of the study is to see how effective Talazoparib is in keeping the cancer from getting worse for at least six months after starting the treatment. Patients will first receive at least four cycles of chemotherapy before beginning the Talazoparib treatment. The study will follow patients to monitor their progress and see if the cancer remains stable. Some patients will receive a placebo instead of Talazoparib to compare the results.

Participants in the study will be divided into three groups, or cohorts, based on the type of mesothelioma they have. The study will last for several years, and during this time, patients will have regular check-ups and tests to track their health and the status of their cancer. The goal is to gather information that could help improve treatment options for people with mesothelioma in the future.

1 initiation of talazoparib treatment

Begin taking Talzenna 1 mg hard capsules. This medication is taken orally.

The treatment starts after a minimum of 6 weeks and a maximum of 8 weeks following the last cycle of platinum-based chemotherapy or after surgery, if applicable.

2 maintenance treatment phase

Continue taking Talzenna daily as a maintenance treatment.

The primary goal is to assess the effectiveness of the treatment by checking if the disease has not progressed 6 months after starting the medication.

3 regular monitoring and assessments

Attend scheduled visits and examinations to monitor health status and treatment effects.

Undergo imaging tests, such as CT scans, to evaluate the disease’s response to the treatment.

4 completion of treatment

The treatment continues until the study’s end date or until the disease progresses.

Follow-up assessments will be conducted to evaluate overall survival and safety.

Who Can Join the Study?

  • Patients must be older than 18 years old.
  • Patients need to have proper liver function, which means:
    • Total bilirubin should be less than or equal to 1.5 times the normal upper limit.
    • ASAT/ALAT levels should be less than or equal to 1.5 times the normal upper limit.
  • Patients should have a life expectancy of at least 16 weeks.
  • Women who can have children must confirm they are not pregnant through a pregnancy test.
  • Women must use a very effective birth control method during treatment and for at least 7 months after finishing therapy. Men with partners who can have children or are pregnant should use a condom during treatment and for at least 4 months after the last dose.
  • Patients must provide written consent to participate in the study.
  • Patients should be part of a social insurance program.
  • Patients must be willing and able to follow the study rules, including attending treatment sessions, scheduled visits, and examinations.
  • Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. This is a scale that measures how well a patient can perform daily activities.
  • Patients must have a confirmed diagnosis of malignant mesothelioma, which is a type of cancer. It should be:
    • Epithelioid, sarcomatoid, or biphasic type.
    • Originating from the pleura (cohort A) or peritoneum (cohorts B1 and B2).
    • Previously treated with at least four cycles of platinum-based chemotherapy, including at least one cycle of pemetrexed, without disease progression during chemotherapy.
  • Patients should not have had previous treatment with bevacizumab or PARP inhibitors.
  • There should be a gap of at least 6 weeks and no more than 8 weeks between the last chemotherapy cycle and the start of talazoparib, or after surgery if no additional chemotherapy was given.
  • For pleural mesotheliomas (cohort A), certain surgeries with or without specific chemotherapy are allowed if the surgery was not fully successful.
  • For peritoneal mesotheliomas:
    • In cohort B1, certain surgeries with or without specific chemotherapy are allowed if the surgery was not fully successful. This group also includes patients who have not had surgery. Some specific treatments are allowed only with systemic chemotherapy.
    • In cohort B2, complete surgery with or without specific chemotherapy is required. Some specific treatments are allowed before surgery.
  • Patients must have a disease that can be measured or evaluated through a CT scan, or for cohort B2, approval of no visible disease on scans.
  • A sample of the tumor, either in a block or at least 30 slides from a biopsy or surgery, must be available at the study site. The sample should be less than 18 months old.
  • Patients need to have proper bone marrow function, which means:
    • Absolute neutrophil count should be at least 1.0 x 109 /L.
    • Platelet count should be at least 50 x 109 /L.
    • Hemoglobin should be at least 8.0 g/dL, even if blood transfusions were needed.
  • Patients need to have proper kidney function, which means a calculated Glomerular Filtration Rate of at least 30 ml/min/1.73 m2 according to a specific formula.

Who Cannot Join the Study?

  • Patients who have not completed at least 4 cycles of a specific type of chemotherapy called platinum-based chemotherapy.
  • Patients who have not been diagnosed with advanced malignant pleural mesothelioma or peritoneal mesothelioma. These are types of cancer that affect the lining of the lungs or abdomen.
  • Patients who are not adults. This means individuals who are not yet 18 years old.
  • Patients who are part of a vulnerable population. This refers to groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Inhkpyuj Rvrivolb Dx Caahlt Dh Mgazxafahop Montpellier France
Akbubgyrik Pblixjax Hppakedv Di Mihgovbsx Marseille France
Hyrnzswg Ufbhomeriwbnct Sxrcgndkto &otzjpi Hmokchx dn Hyobgcwfkkv STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
21.06.2024

Trial locations

Investigated drugs:

Talazoparib is a medication being studied for its effectiveness in maintaining the health of patients with advanced malignant pleural or peritoneal mesothelioma. It is used after patients have completed at least four cycles of initial chemotherapy that includes platinum-based drugs. The goal is to see if this medication can help keep the disease from progressing for at least six months.

Malignant Pleural Mesothelioma – This is a type of cancer that occurs in the thin layer of tissue covering the lungs and chest wall. It is primarily associated with asbestos exposure. The disease progresses as cancer cells grow and spread in the pleura, leading to symptoms such as chest pain, shortness of breath, and fluid buildup around the lungs. Over time, the tumor may invade nearby structures and organs. The progression can vary, with some cases advancing more rapidly than others.

Malignant Peritoneal Mesothelioma – This cancer affects the lining of the abdomen, known as the peritoneum. Like pleural mesothelioma, it is linked to asbestos exposure. The disease progresses as cancerous cells multiply and spread within the abdominal cavity, causing symptoms like abdominal pain, swelling, and digestive issues. As it advances, it can lead to the accumulation of fluid in the abdomen and affect nearby organs. The rate of progression can differ among individuals, with some experiencing a slower course.

Trial ID:
2024-514104-14-00
Protocol code:
69HCL19_0457
NCT ID:
NCT04462809
Trial Phase:
Therapeutic exploratory (Phase II)

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