Safety and Efficacy of Olaparib Combined with Agents Targeting DNA Damage Repair Compared to Olaparib Alone
Study Contact Information:
Contact AstraZeneca Clinical Study Information Center by phone: 877-240-9479 or email
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:
- Patients with or gene mutations.
- Patients with mutations in any of the other genes, and no mutation in and no mutation in .
- 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.
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.
What the Study Involves
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
Study Contact Information:
Contact AstraZeneca Clinical Study Information Center by phone: 877-240-9479 or email
Study Contact Information:
Contact AstraZeneca Clinical Study Information Center by phone: 877-240-9479 or email