Study of Senaparib and Temozolomide for Ovarian Cancer with ARID1A Mutation

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60

ClinicalTrials ID:NCT06617923

Provider View

This clinical trial is testing the effectiveness of combining two drugs, Senaparib and Temozolomide, in treating ovarian cancer that has a specific genetic mutation called ARID1A. The study focuses on patients with clear cell or endometrioid ovarian cancer.

Patient Parameters

Program Overview

This phase 2 study aims to evaluate how well the combination of Senaparib and Temozolomide works in shrinking tumors in patients with certain types of ovarian cancer that have a specific genetic mutation known as ARID1A. The study will involve up to 18 adult women who will take Senaparib and Temozolomide in cycles, with regular assessments to monitor tumor response and any side effects.

Description

This study involves taking two drugs, Senaparib and Temozolomide, to see if they can effectively treat certain types of ovarian cancer that have a specific genetic mutation. Up to 18 women will participate, taking Senaparib daily and Temozolomide for most days in a 28-day cycle. Doctors will check the tumors every 8 weeks initially, then every 12 weeks, to see if the treatment is working. The treatment will continue unless there are severe side effects, the cancer progresses, or the patient decides to stop. Participants must meet specific health criteria and agree to regular check-ups and tests.

Eligibility Criteria

Inclusion Criteria

  • Must understand and agree to sign a consent form.
  • Have a confirmed diagnosis of recurrent or persistent clear cell or endometrioid ovarian cancer.
  • Have a specific ARID1A genetic mutation confirmed by tests.
  • Have measurable cancer that can be tracked by scans or exams.
  • Have received at least two prior chemotherapy treatments or have cancer that is resistant to platinum-based treatments.
  • Be able to take oral medications and not have digestive issues that affect absorption.
  • Be female, aged 18 or older.
  • Have good overall health and organ function as determined by specific blood tests.
  • Agree to use effective birth control during the study and for one month after the last dose.
  • Have no active hepatitis B or C infections, or have these conditions under control.
  • Have treated brain metastases with no progression for at least 12 weeks.
  • Have no other cancers that could interfere with the study.
  • Have no severe heart disease.

Exclusion Criteria

  • Have previously taken a PARP inhibitor or Temozolomide.
  • Are currently in another clinical trial or have taken investigational drugs recently.
  • Have not recovered from side effects of previous treatments.
  • Have a history of certain blood cancers or genetic abnormalities.
  • Have bowel obstruction or severe health conditions.
  • Are pregnant or breastfeeding.
  • Have untreated brain metastases.
  • Have allergies to similar drugs.
  • Are taking certain medications that interact with the study drugs.
  • Have uncontrolled infections or significant health issues that could affect participation.

Locations

FACILITYZIPCITYSTATE
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins21231-2410BaltimoreMaryland

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