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Olaparib Combined with Agents Targeting DNA Damage Repair Compared to Olaparib Alone

Clinicaltrials.gov identifier:
NCT03330847

Treatment

Study Contact Information:

Contact AstraZeneca Clinical Study Information Center by phone: 877-240-9479 or email

Safety and Efficacy of Olaparib Combined with Agents Targeting DNA Damage Repair Compared to Olaparib Alone

NOTE: This study is no longer enrolling patients. 

About the Study

The purpose of this study is to assess the efficacy and safety of treatment with the , combined with the drug Ceralasertib compared with  alone for patients with .

The study outcomes will be analyzed for the following three patient populations:

  1. Patients with or gene mutations.
  2. Patients with mutations in any of the other genes, and no mutation in and no mutation in .
  3. Patients with no detected tumor mutations in any of the repair (HRR) genes. is a method that normal cells use to repair damage to .

Type of Study

This is an open label, , two-arm study that will enroll 350 people. 

  • The study has two arms. All participants will be placed into one of two groups. 
    • One group of patients will receive as a single agent. 
    • One group of patients will receive combined with the drug ceralasertib.
  • This is a study, which means that participants will be placed into one of the two groups by chance. Neither patients nor the research doctor will choose the group participants are placed in.
  • The study is . All participants will know which group they are assigned to.

What the Study Entails

Eligible patients will be into one of two treatment arms:

  • Arm #1: Study participants will take 300mg orally in 28-day cycles.
  • Arm #2: Study participants will take 300mg orally in a 28-day cycle. These participants will take Ceralasertib 160 mg from Day 1 to Day 7 (inclusive) of every 28-day cycle.

Patients will remain on the study until date of first documented progression of disease or an that keeps the participant from continuing on the study. 

Study Locations

State City
Alaska Anchorage
Arizona Gilbert
California Palm Springs
Colorado Aurora
Connecticut New Haven
Georgia Marietta
Illinois Chicago
Indiana Munster
Kentucky Hazard
Louisville
Maryland Baltimore
Bethesda
Missouri Kansas City
New Jersey Brick
New York East Setauket
Lake Success
Mineola
Mount Kisco
Stony Brook
Ohio Cincinnati
Kettering
Oregon Corvallis
Tenessee Knoxville
Texas Dallas
Washington Olympia
Seattle

Sites are also open in Canada and the United Kingdom. 

Principal Investigator

Andrew Tutt, MB ChB PhD
Guy's Hospital, Great Maze Pond, London

This Study is Open To:

NOTE: This study is no longer enrolling patients. 

This Study is Not Open To:

Patients will be excluded if they:

  • have received treatment within 21 days of beginning the study. 
  • they received more than 2 prior lines of chemotherapy for disease.
  • they received previous treatment with a or other drug that inhibits Damage Response, unless they received the drugs for less than 3 weeks, and it has been at least 12 months since receiving the drug. 
  • they have a second primary cancer.
  • they have cardiac disease
  • they are immunocompromised (e.g., HIV).
  • they have active hepatitis B or C.
  • they have symptomatic uncontrolled brain metastases.
  • they are unable to swallow orally administered medication and/or have gastrointestinal disorders likely to interfere with absorption of the study medication.