Study on AZD1775 for Treating Cancers with BRCA Genetic Changes
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04439227
This clinical trial is testing a new drug, AZD1775, to see if it can help shrink or stop the growth of cancers that have a specific genetic change known as a BRCA mutation.
Patient Parameters
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Program Overview
The purpose of this study is to find out if AZD1775, a drug that may block a protein called WEE1, can effectively treat cancers with BRCA mutations. Researchers want to see if this drug can shrink tumors or stop them from growing in patients with these genetic changes.
Description
The main goal of this study is to see how many patients with advanced cancers respond to the treatment with AZD1775. Researchers will also look at how long patients live without their cancer getting worse and how long it takes for the cancer to progress or for the patient to pass away. They will study other factors that might predict how well the treatment works, using different tests on the cancer cells and imaging scans.
In this study, patients will take AZD1775 by mouth once a day for five days, take a break, and then take it again for another five days. This cycle repeats every 21 days as long as the cancer does not get worse and the patient can tolerate the treatment.
After finishing the treatment, patients will have follow-up visits every three months for up to two years, and then every six months for another year.
Eligibility Criteria
Inclusion Criteria
- Must meet the eligibility criteria of the main MATCH study before joining this treatment study.
- Must have a BRCA1 or BRCA2 gene mutation in their tumor, or another specific genetic change as identified in the main MATCH study. Tumors with uncertain genetic changes do not qualify.
- Patients with ovarian cancer or HER2 negative, metastatic breast cancer must have previously received a PARP inhibitor as part of their treatment.
- Must have a recent electrocardiogram (ECG) showing no major heart rhythm problems.
- If taking certain medications that affect the liver enzyme CYP3A4, these must be reviewed by the study doctor. Some medications are not allowed.
- Must have a hemoglobin level of at least 9 g/dL, checked within four weeks before starting the treatment.
- Must have a specific heart rhythm measurement (QTc interval) within normal limits before joining the study.
Exclusion Criteria
- Cannot have an allergy to AZD1775 or similar drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | 19103 | Philadelphia | Pennsylvania |
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