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Study of the PARP inhibitor AZD9574 Alone and Combined with Other Cancer Medicines to Treat People with Advanced Solid Cancers (CERTIS1 Study)

Clinicaltrials.gov identifier:
NCT05417594

Treatment
Treatment study for people with advanced breast, ovarian, pancreatic or prostate cancer or gliomas

Study Contact Information:

For additional information, please contact:

AstraZeneca Clinical Study Information Center by phone: 1-877-240-9479 or email: [email protected]


Study of the PARP inhibitor AZD9574 Alone and Combined with Other Cancer Medicines to Treat People with Advanced Solid Cancers (CERTIS1 Study)

About the Study

This research involves studying a drug called AZD9574 on its own and in combination with other anti-cancer drugs in people with advanced cancer that has come back or progressed. AZD9574 is a type of known as a . The study aims to understand the safety, tolerance, how the drug moves in the body, how it affects the body, and its initial effectiveness.

What the Study Involves

People will be enrolled and assigned to study treatments. This study consists of individual groups each evaluating the safety and effectiveness of the drug AZD9574.

Study Groups:

Group 1

  • Part A:
    • Participants with advanced or recurrent (cancer that has come back) ovarian, breast, pancreatic, or cancer who are eligible for a will receive increasing doses of the drug AZD9574.
  • Part B:
    • Participants with breast cancer who have a , , , or mutation who have not had treatment with a will receive the drug AZD9574.

Group 2

  • Part A:
    • Participants with IDH 1/2-mutant glioma, commonly observed in lower-grade glioma and secondary glioblastomas, who have not had treatment with a will receive increasing doses of the drug AZD9574 in combination with Temozolomide (TMZ.)
       

Study Sites - United States

California

  • Los Angeles
    UCLA 
  • San Francisco
    UCSF

Illinois

  • Chicago
    Robert H. Lurie Comprehensive Cancer Center

Massachusetts

  • Boston
    Dana-Farber Cancer Institute

New York

  • New York
    Memorial Sloan Kettering

Oregon

  • Portland
    OHSU Knight Cancer Institute

Texas

  • Houston
    MD Anderson Cancer Center

Study Sites - International

  • Australia
  • Korea
  • Spain
  • Sweden

 

This Study is Open To:

People who:

  • are 18 years of age and older.
  • are not pregnant or plan to become pregnant during the study and agree to use two methods of contraception while in the study until 3 months after the study.
  • have cancer that has recurred or progressed.
  • are eligible to receive a
  • have a visible lump or spot that hasn't been treated with radiation before and can be accurately measured at the beginning of the study.

Group 1 participants who:

  • have received platinum chemotherapy for advanced breast cancer are eligible to enter the study provided there has been no evidence of disease progression during the platinum chemotherapy.
  • have received prior platinum-based chemotherapy as neoadjuvant/adjuvant treatment (treatment prior to, or after surgery) are eligible provided at least 12 months have elapsed between the last dose of platinum-based treatment and first dose when enrolled in the study.

Group 2 participants must also meet these criteria:

  • must have IDH1/2-mutant glioma.
  • should have progressive disease after prior radiation therapy and one prior line of alkylating chemotherapy for their disease.
  • have a recurrent disease thar is evaluable by .
This Study is Not Open To:

People who:

  • had major surgery within 4 weeks of the first dose of study medication.
  • underwent wide radiation treatment within the last 4 weeks or received limited radiation for relief purposes within the last 2 weeks from the first dose of the study intervention.
  • have a history of uncontrolled seizures or with need for administration of more than 2 antiepileptic drugs, or history of epileptic disorder or any seizure history unrelated to tumor.
  • have a history of severe brain injury or stroke.
  • have any evidence of severe or uncontrolled systemic diseases including active bleeding diathesis, active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).