Testing the Combination of Anti-Cancer Drugs Talazoparib and Temozolomide in Patients with Advanced Stage Rare Cancers (RARE 2 Trial)

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05142241

Provider View

This clinical trial is exploring whether a combination of two drugs, talazoparib and temozolomide, can help shrink tumors in patients with advanced rare cancers that have spread. The study aims to see if these drugs can stop cancer cells from repairing themselves, leading to their death.

Patient Parameters

Program Overview

This study is testing a combination of two drugs, talazoparib and temozolomide, to see if they can shrink tumors in patients with advanced rare cancers. Talazoparib is a type of targeted therapy that blocks an enzyme called PARP, which helps cancer cells repair their DNA. By blocking PARP, talazoparib may prevent cancer cells from fixing their damaged DNA, causing them to die. Temozolomide is a medication that damages the DNA of cancer cells, which may also lead to their death. The study hopes that using these drugs together can help control or reduce the growth of advanced rare cancers.

Description

The main goal of this study is to see how many patients with advanced rare cancers respond to the treatment with talazoparib and temozolomide. Researchers will also look at how many patients are alive and have not seen their cancer progress after six months of treatment. They will study tumor samples to understand why some cancers respond to the treatment and others do not.

Patients in the study will take talazoparib by mouth every day and temozolomide by mouth for five days in a 28-day cycle. This cycle will repeat as long as the treatment is working and not causing unacceptable side effects. Patients will have CT scans and may have biopsies or blood samples taken to monitor their progress.

After finishing the study treatment, patients will be followed up for 30 days or until they start another treatment, receive standard care, or pass away, whichever happens first.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of a rare solid tumor that has progressed after standard treatment or for which no standard treatment is available.
  • Not be eligible for a higher priority study, such as a disease-specific study of phase 2 or higher.
  • Have measurable disease that can be accurately measured by scans.
  • Be willing to provide a tumor sample for biopsy if required.
  • Have recovered from any previous treatments and be at least 3 weeks out from radiation or major surgery.
  • Be at least 18 years old, or between 12 and 17 years old with a body surface area of at least 1.5 m².
  • Have a performance status that allows for daily activities with some restrictions.
  • Have adequate blood counts and organ function as determined by specific tests.
  • Agree to use effective contraception during the study and for 7 months after treatment.
  • Be willing to sign a consent form and understand the study requirements.

Exclusion Criteria

  • Have significant nerve damage or neuropathy.
  • Be receiving other investigational treatments.
  • Have active brain metastases or cancer in the brain lining unless treated and stable.
  • Have a history of severe allergic reactions to similar drugs.
  • Have significant liver disease or active hepatitis.
  • Have uncontrolled illnesses or conditions that would interfere with the study.
  • Be pregnant or breastfeeding, as the drugs may harm the baby.

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