Study on Multiple Anti-Cancer Treatments for Patients with Metastatic Prostate Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT07590934
This clinical trial is testing the safety and effectiveness of various anti-cancer treatments in men with metastatic prostate cancer. The study aims to find the best doses and see how well these treatments work in reducing cancer markers.
Patient Parameters
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Program Overview
The study is designed to evaluate the safety, how the body processes the drugs, and the initial effectiveness of different anti-cancer treatments in men with metastatic prostate cancer. It will involve several smaller studies, each testing different treatment combinations. The goal is to find the best dose and see if the treatments can lower prostate cancer markers by at least 50%.
Description
This study involves testing multiple anti-cancer treatments in men with metastatic prostate cancer. It is divided into smaller studies, each with two parts:
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Part A: This phase will test different doses to find out which ones are safe and how the body handles them. It will also look for any side effects and see if the treatments show early signs of working against the cancer.
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Part B: This phase will use the best dose found in Part A to see how well it works in a larger group of patients. The main goal is to see if the treatment can reduce prostate cancer markers by at least 50%.
One of the smaller studies will focus on a specific treatment combination, comparing the safety and effectiveness of a new drug combination against standard chemotherapy in men with metastatic castration-resistant prostate cancer.
Eligibility Criteria
Inclusion Criteria
- Men diagnosed with prostate cancer that has spread and is not the small cell or other rare types.
- Expected to live at least 3 more months.
- In good general health and able to perform daily activities.
- Cancer that can be measured by scans.
- Previously treated with at least one specific prostate cancer medication.
- Have one or more cancer spots that cannot be surgically removed.
- Have had surgery or ongoing treatment to lower testosterone levels.
- Cancer that has progressed despite recent treatment.
- Healthy organ and bone marrow function.
- Agree to use effective birth control methods if sexually active.
For Sub-study 1:
- Previously treated with one specific prostate cancer medication.
- Cancer that shows a specific marker on scans.
- Able to take oral medications.
Exclusion Criteria
- Prostate cancer that is not adenocarcinoma.
- Blocked urinary tract.
- History of cancer spreading to the brain or spinal cord.
- Serious medical conditions or infections.
- Previous lung disease or blood disorders.
- Unable to take oral medications.
- Allergic to study drugs.
For Sub-study 1:
- History of uncontrolled seizures or severe brain injury.
- Specific bone scan results.
- Previously treated with certain cancer drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 91436 | Encino | California |
| Research Site | 91030 | South Pasadena | California |
| Research Site | 33165 | Miami | Florida |
| Research Site | 33612 | Tampa | Florida |
| Research Site | 70006 | Metairie | Louisiana |
| Research Site | 55455 | Minneapolis | Minnesota |
| Research Site | 68130 | Omaha | Nebraska |
| Research Site | 10065 | New York | New York |
| Research Site | 97239 | Portland | Oregon |
| Research Site | 77030 | Houston | Texas |
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