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

Clinicaltrials.gov identifier:
NCT04644068

Treatment
Advanced ovarian, breast, prostate or pancreatic cancer

Study Contact Information:

For more information, contact the study coordinator:
Natalie Velez by email at [email protected]

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 , AZD5305 taken orally, either alone or combined with other anti-cancer therapies in patients with advanced ovarian, breast, or pancreatic cancer with an in one of the following genes: , , , or . 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 , 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.

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This Study is Open To:

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

advanced ovarian, breast, or pancreatic cancer
an or tumor mutation in , , , or
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
must be at least 21 days from last treatment (exact timing from last treatment varies by group)
otherwise in reasonably good health

This Study is Not Open To:

history of prolonged decreases in red blood cell counts, white blood cell counts or platelets
brain metastases, unless appropriately treated and neurologically stable
leptomeningeal
active bacterial, viral, or fungal infection(s) requiring 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