Study on the Safety and Effectiveness of DNA Repair Targeting Agents with Olaparib Compared to Olaparib Alone

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT03330847

Provider View

This clinical trial is exploring whether combining the drug olaparib with other medications that target DNA repair can improve treatment outcomes for patients with advanced triple-negative breast cancer (TNBC). The study will compare olaparib alone to olaparib combined with either Ceralasertib or Adavosertib, although the latter combination has been discontinued.

Patient Parameters

Program Overview

The purpose of this study is to determine if using olaparib, a medication that targets cancer cells with DNA repair issues, alone or in combination with other drugs, can effectively treat patients with advanced triple-negative breast cancer (TNBC). The study will compare olaparib alone to olaparib combined with Ceralasertib, a drug that targets a specific protein involved in DNA repair. The combination with Adavosertib has been discontinued, but patients previously on this treatment can continue with olaparib alone. Participants will be divided into groups based on specific genetic mutations related to DNA repair and their previous treatments.

Description

This study is a Phase 2 trial that will test the effectiveness and safety of olaparib, a drug used to treat certain types of cancer, either alone or in combination with other drugs that target DNA repair mechanisms. The study involves patients with advanced triple-negative breast cancer (TNBC) who have specific genetic mutations affecting DNA repair.

Participants will be randomly assigned to one of two treatment groups: one receiving olaparib alone and the other receiving olaparib with Ceralasertib. The combination with Adavosertib has been discontinued, but those already on it can switch to olaparib alone. The study will assess how well these treatments work in controlling cancer progression and their safety profiles.

Patients will be grouped based on their genetic mutations related to DNA repair and whether they have received certain prior treatments. The study will measure outcomes like progression-free survival, response rates, and overall survival. Participants will take olaparib tablets twice daily, and those in the combination group will also take Ceralasertib for a specified period each cycle. The study aims to provide insights into the best treatment strategies for patients with TNBC and specific genetic profiles.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent before any study procedures.
  • Male or female, 18 years or older.
  • Cancer must be progressing at the time of study entry.
  • Must have confirmed triple-negative breast cancer (TNBC) with evidence of metastatic disease and be HER2 negative.
  • Must have received 1-2 prior treatments for metastatic disease, including specific chemotherapy drugs, unless contraindicated.
  • Must have a confirmed presence or absence of specific DNA repair mutations in tumor tissue.
  • Must have at least one measurable tumor that can be assessed by scans.
  • Must have normal organ and bone marrow function as defined in the study protocol.
  • Must have an ECOG performance status of 0-1.
  • Women of childbearing potential must be postmenopausal or use effective contraception.
  • Must be willing to comply with study requirements and have a life expectancy of at least 16 weeks.

Exclusion Criteria

  • Cannot have received certain cancer treatments within 21 days before starting the study.
  • Cannot have had more than 2 prior chemotherapy treatments for metastatic disease.
  • Cannot have participated in this study before.
  • Cannot have been treated with a PARP inhibitor or other DNA repair inhibitors recently.
  • Cannot have used certain investigational drugs recently.
  • Cannot have a second primary cancer, with some exceptions.
  • Cannot have certain heart conditions or abnormal heart rhythms.
  • Cannot use certain medications that affect drug metabolism.
  • Cannot have unresolved side effects from previous cancer treatments.
  • Cannot have had major surgery recently.
  • Cannot be immunocompromised or have active hepatitis.
  • Cannot have uncontrolled brain metastases.
  • Cannot have difficulty swallowing or absorbing oral medications.
  • Cannot be allergic to study drugs or their ingredients.
  • Cannot be pregnant or breastfeeding.

Locations

FACILITYZIPCITYSTATE
Research Site35205BirminghamAlabama
Research Site99508AnchorageAlaska
Research Site85234GilbertArizona
Research Site80045AuroraColorado
Research Site06511New HavenConnecticut
Research Site60637ChicagoIllinois
Research Site46321MunsterIndiana
Research Site41701HazardKentucky
Research Site40207LouisvilleKentucky
Research Site21204TowsonMaryland

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