Investigational PARP Inhibitor AZD5305 Alone or Combined With Other Anti-cancer Agents in People With Advanced Solid Tumors (PETRA)

About the Study

PETRA is a study of a new, investigational PARP inhibitor, AZD5305 taken orally, either alone or combined with other anti-cancer therapies in patients with advanced ovarian, breast, prostate or pancreatic cancer with an inherited mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C or RAD51D. The combination available and which group you are assigned to will depend on your cancer type and mutation and when you join the study.

What the Study Entails

• This is an open label trial, with no placebo; everyone in the study will receive the PARP inhibitor, AZD5305. The dosage and if you will receive an additional drug will depend on your cancer type, mutation and availability of spots at the time you join.
• Each group will have slightly different visits; however, you will generally be required to follow this schedule:
  • weekly for the first month
  • bi-weekly for the second month
  • monthly thereafter
• In order to qualify participants will need to have lab draws, imaging studies, EKG’s and physical exams. Some groups will require additional tests such as an exam with an eye doctor and a type of heart exam known as an echocardiagram.
• During study there is additional monitoring, including:
  • EKG monitoring, at-home blood pressure monitoring and electronic pill diary completion.
• AZD5305 is taken orally on an empty stomach once a day. The number of pills you take is dependent on which group you are enrolled in.
• Imaging scans to assess disease will be conducted approximately every two months.
• Participants will receive a safety follow-up approximately 28 days after their last dose.

Study Sites

New York
New York City, NY
Memorial Sloane Kettering
Allison Schram

Texas
Houston, TX 
MD Anderson
Dr Timothy Yap
Contact: Natalie Velez by email at [email protected]

Participants 18 years and older with the following may be eligible to participate:

• advanced ovarian, breast, prostate or pancreatic cancer
• an inherited mutation or tumor mutation in BRCA1, BRCA2, PALB2, RAD51C or RAD51D
• willing to provide blood and tumor tissue samples for testing if required
• adequate immune, liver and kidney function and adequate blood count
• resolved treatment related toxicity
• must be at least 21 days from last treatment (exact timing from last treatment varies by group)
• otherwise in reasonably good health

• history of prolonged decreases in red blood cell counts, white blood cell counts or platelets
• brain metastases, unless appropriately treated and neurologically stable
• leptomeningeal metastasis
• active bacterial, viral, or fungal infection(s) requiring systemic therapy including Hepatitis B, Hepatitis C, HIV+
• pregnant or breast-feeding
• other known active cancers
• history of significant heart abnormalities
• some, but not all participant groups may not allow prior treatment with PARP inhibitors - check with study coordinator
• use of certain medication that ma affect heart rhythm or unresolved treatment related toxicity