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Study Summary
This trial is testing a new drug to see if it is safe and tolerated by adults. They will also be trying to determine the highest dose of the drug that can be given without causing serious side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have had brain metastases treated and they have not worsened since my last treatment.My heart is functioning well.My testosterone levels are low, at or below 50 ng/dL.I have had no more than 4 previous cancer treatments, including hormone and chemotherapy.My bilirubin levels are within the required range.I have an autoimmune disease or need permanent immunosuppressive therapy.My kidney function is within normal ranges.I have advanced prostate cancer that didn't respond to specific hormone therapies and have tried or can't try taxane treatments.I have had a clot in my arteries or veins but it's been stable for the required time.I have not had signs of a serious infection in the last 7 days.I have been treated with a new antiandrogen therapy for my metastatic disease.I have never taken abiraterone acetate before.My blood counts are within normal ranges.My hemoglobin level is at least 9 g/dL without recent blood transfusions.My prostate cancer is not adenocarcinoma but a different type.I haven't had radiation therapy in the last 4 weeks.I haven't had a heart attack or severe heart failure in the last year.I haven't had cancer treatment in the last 4 weeks, except for hormone therapy.I have metastatic prostate cancer and have had limited hormone or chemotherapy.I have never taken enzalutamide or similar medications before.I have had surgery to remove both testicles or am on hormone therapy for cancer.I have mCRPC and have had at most one type of hormone therapy but never docetaxel.I am fully active or can carry out light work.My liver is working well.My platelet count is healthy without recent transfusions.My kidney function, based on a specific test, is at a safe level for the trial.My organs are functioning well.
- Group 1: Part 1: AMG 509 Intravenous (IV) Monotherapy
- Group 2: Part 2: AMG 509 Subcutaneous (SC) Monotherapy
- Group 3: Part 3: AMG 509 IV Monotherapy in Earlier Lines of Treatment
- Group 4: Part 4: AMG 509 IV Combination Therapy
- Group 5: Part 5: AMG 509 IV Monotherapy in Outpatient Setting
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any slots left for participants in this clinical trial?
"Exactly. The records on clinicaltrials.gov indicate that recruitment for this trial is currently underway, with the initial posting being March 4th 2020 and last update of November 18th 2022. This project requires 459 volunteers across 11 different medical sites to be enrolled in order to complete its goals."
What is the aggregate figure for participants in this clinical trial?
"Affirmative. The clinical trial is recruiting patients, as per information on the official website. This study was initially advertised in March 4th 2020 and was last updated November 18th 2022. A total of 459 individuals need to be recruited from 11 sites participating in this research endeavour."
Has AMG 509 been granted regulatory approval by the FDA?
"According to our team at Power, the safety of AMG 509 has been judged a 1 due to its Phase 1 classification. This indicates that there is limited clinical data regarding its efficacy and safety."
How many healthcare facilities are offering this clinical trial at present?
"This research is being executed in 11 distinct sites, including Sioux Falls, Duarte and Cincinnati. To limit the strain of travel when participating, it's beneficial to select the clinical trial centre closest to you."
What are the key aims of this medical trial?
"The primary objective of Amgen's study, which will be monitored over a 3-year period, is to examine changes in clinical laboratory test results. Additionally, they are evaluating secondary outcomes such as Alkaline phosphatase (total & bone), Duration of Response (radiographic and PSA) and Hemoglobin; all with the aim of assessing AMG 509's anti-tumor activity per PCWG3 recommendations."
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