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Protein Kinase Inhibitor

AMG 509 for Prostate Cancer

Phase 1
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cardiac function:
Total serum testosterone <= 50 ng/dL or 1.7 nmol/L.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 1, 2, and 3
Awards & highlights

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.

Who is the study for?
Men with advanced prostate cancer that has spread and is resistant to hormone therapy can join. They should have tried a new antiandrogen treatment for metastatic disease, but not more than two taxane chemotherapies. Participants must be on or have had hormonal suppression therapy, show signs of cancer progression, and have good blood counts and organ function.Check my eligibility
What is being tested?
The trial tests AMG 509's safety and the highest dose patients can tolerate without severe side effects (MTD/RP2D). It also looks at how well it works in men who are about to start treatments like abiraterone or enzalutamide for the first time.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation, such as inflammation in different parts of the body, fatigue, changes in blood cell counts which could affect infection risk or cause anemia, liver enzyme alterations indicating liver stress, and potential heart issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart is functioning well.
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My testosterone levels are low, at or below 50 ng/dL.
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I have had no more than 4 previous cancer treatments, including hormone and chemotherapy.
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My bilirubin levels are within the required range.
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My kidney function is within normal ranges.
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I have advanced prostate cancer that didn't respond to specific hormone therapies and have tried or can't try taxane treatments.
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I have been treated with a new antiandrogen therapy for my metastatic disease.
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I have never taken abiraterone acetate before.
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My blood counts are within normal ranges.
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My hemoglobin level is at least 9 g/dL without recent blood transfusions.
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I have metastatic prostate cancer and have had limited hormone or chemotherapy.
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I have never taken enzalutamide or similar medications before.
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I have had surgery to remove both testicles or am on hormone therapy for cancer.
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I have mCRPC and have had at most one type of hormone therapy but never docetaxel.
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I am fully active or can carry out light work.
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My liver is working well.
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My platelet count is healthy without recent transfusions.
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My kidney function, based on a specific test, is at a safe level for the trial.
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My organs are functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 1, 2, and 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and year 1, 2, and 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicities (DLTs)
Incidence of treatment-emergent adverse events
Incidence of treatment-related adverse events
+3 more
Secondary outcome measures
1, 2, and 3-year overall survival (OS)
1, 2, and 3-year radiographic PFS
6 month radiographic PFS
+19 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 5: AMG 509 IV Monotherapy in Outpatient SettingExperimental Treatment1 Intervention
Part 5 will evaluate the safety and tolerability of AMG 509 IV dosing in participants with mCRPC who have been previously treated with NHT and 1 to 2 prior taxanes, when administered in outpatient infusion centers. The Part 5 dosing regimen and schedule was selected based on emerging data and DLRT recommendations and will utilize the doses explored in Part 1 dose-expansion phase
Group II: Part 4: AMG 509 IV Combination TherapyExperimental Treatment3 Interventions
Part 4 will explore the safety, tolerability, and PK of AMG 509 for participants with mCRPC who have received no or 1/2 prior NHT (for hormone sensitive or castration-resistant disease) at dose regimens previously determined to be safe and tolerable in Part 1, in combination with abiraterone (Part 4A), or enzalutamide (Part 4B) and no or 1 prior taxane for hormone sensitive disease in Parts 4A and 4B. Part 4 consists of a dose exploration phase and a dose expansion phase. This dose exploration study will estimate the MTD and/or RP2D of AMG 509 in combination with abiraterone or enzalutamide using a modified toxicity probability interval design. The dose-expansion phase will confirm safety, PK, and PD at the MTD or RP2D and to obtain further safety and efficacy data and correlative biomarker analysis.
Group III: Part 3: AMG 509 IV Monotherapy in Earlier Lines of TreatmentExperimental Treatment1 Intervention
Part 3 will explore AMG 509 in participants with mCRPC who have received 1 prior NHT (may have been given for HSPC) and no prior taxanes (may have been given for HSPC). This dose expansion will be conducted to confirm safety, PK, and PD of AMG 509 at the MTD or RP2D determined in Part 1 dose exploration, and to obtain further safety and efficacy data and correlative biomarker analysis.
Group IV: Part 2: AMG 509 Subcutaneous (SC) MonotherapyExperimental Treatment1 Intervention
Part 2 will explore the safety, tolerability, and PK of AMG 509 SC dosing in participants with mCRPC who have been previously treated with NHT and 1 to 2 prior taxanes. Recommended phase 2 dose for SC monotherapy may be identified based on emerging safety, efficacy, PK, and PD data, as well as patient experience prior to reaching an MTD.
Group V: Part 1: AMG 509 Intravenous (IV) MonotherapyExperimental Treatment1 Intervention
Part 1 will evaluate AMG 509 in participants with metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with novel hormonal therapy (NHT) and 1 to 2 prior taxanes. The dose exploration phase of the study will estimate the MTD of AMG 509 using a Bayesian logistic regression model (BLRM; Neuenschwander et al, 2008). RP2D may be identified based on emerging safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) data, as well as patient experience prior to reaching an MTD. Alternative dosing schedule(s) (including a third step dose) may be explored based on emerging efficacy, safety, PK data and patient experience. During the dose expansion phase, individual cohorts of participants from China will be enrolled with a safety lead-in at 1 dose level below the MTD or RP2D followed by evaluation at the MTD or RP2D to confirm the safety, tolerability, MTD and/or RP2D of AMG 509 in Chinese participants.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone
2012
Completed Phase 4
~2830
Enzalutamide
2014
Completed Phase 4
~2760

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,362 Previous Clinical Trials
1,384,810 Total Patients Enrolled
12 Trials studying Prostate Cancer
4,383 Patients Enrolled for Prostate Cancer
MDStudy DirectorAmgen
904 Previous Clinical Trials
922,305 Total Patients Enrolled
7 Trials studying Prostate Cancer
4,288 Patients Enrolled for Prostate Cancer

Media Library

AMG 509 (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04221542 — Phase 1
Prostate Cancer Research Study Groups: Part 1: AMG 509 Intravenous (IV) Monotherapy, Part 2: AMG 509 Subcutaneous (SC) Monotherapy, Part 3: AMG 509 IV Monotherapy in Earlier Lines of Treatment, Part 4: AMG 509 IV Combination Therapy, Part 5: AMG 509 IV Monotherapy in Outpatient Setting
Prostate Cancer Clinical Trial 2023: AMG 509 Highlights & Side Effects. Trial Name: NCT04221542 — Phase 1
AMG 509 (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04221542 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~147 spots leftby Mar 2026