AMG 509 for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Prostate CancerAMG 509 - Drug
Eligibility
18+
Male
What conditions do you have?
Select

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.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

8 Primary · 19 Secondary · Reporting Duration: Year 1, 2, and 3

3 years
Accumulation following multiple dosing for AMG 509
Alkaline phosphatase (total, bone)
Area under the concentration-time curve (AUC) over the dosing interval for AMG 509
Circulating tumor cells response (CTC0)
Dose limiting toxicities (DLTs)
Duration of response (DOR) (radiographic and PSA)
Hemoglobin
Incidence of treatment-emergent adverse events
Incidence of treatment-related adverse events
Lactate dehydrogenase (LDH)
Maximum serum concentration (Cmax) for AMG 509
Minimum serum concentration (Cmin) for AMG 509
Neutrophil-to-lymphocyte ratio
Number of participants with changes in the clinical laboratory tests results
Number of participants with changes in the clinical laboratory tests results.
Number of participants with changes in the electrocardiogram (ECG) records
Number of participants with changes in the electrocardiogram (ECG) records.
Number of participants with changes in vital signs
Malignant Neoplasms
Progression-free survival (PFS) (radiographic and PSA)
Prostate specific antigen (PSA) response
Rate of circulating tumor cells CTC conversion
Time to maximum serum concentration (Tmax) for AMG 509
Time to progression (radiographic and PSA)
Time to symptomatic skeletal events
Urine N-telopeptide
Year 1
1, 2, and 3-year overall survival (OS)

Trial Safety

Safety Progress

1 of 3

Similar Trials

Trial Design

7 Treatment Groups

Part 5: AMG 509 IV Monotherapy in Outpatient Setting
1 of 7
Dose expansion phase
1 of 7
Dose exploration phase
1 of 7
Part 1: AMG 509 Intravenous (IV) Monotherapy
1 of 7
Part 2: AMG 509 Subcutaneous (SC) Monotherapy
1 of 7
Part 3: AMG 509 IV Monotherapy in Earlier Lines of Treatment
1 of 7
Part 4: AMG 509 IV Combination Therapy
1 of 7

Experimental Treatment

459 Total Participants · 7 Treatment Groups

Primary Treatment: AMG 509 · No Placebo Group · Phase 1

Part 5: AMG 509 IV Monotherapy in Outpatient Setting
Drug
Experimental Group · 1 Intervention: AMG 509 · Intervention Types: Drug
Dose expansion phase
Drug
Experimental Group · 1 Intervention: AMG 509 · Intervention Types: Drug
Dose exploration phase
Drug
Experimental Group · 1 Intervention: AMG 509 · Intervention Types: Drug
Part 1: AMG 509 Intravenous (IV) Monotherapy
Drug
Experimental Group · 1 Intervention: AMG 509 · Intervention Types: Drug
Part 2: AMG 509 Subcutaneous (SC) Monotherapy
Drug
Experimental Group · 1 Intervention: AMG 509 · Intervention Types: Drug
Part 3: AMG 509 IV Monotherapy in Earlier Lines of Treatment
Drug
Experimental Group · 1 Intervention: AMG 509 · Intervention Types: Drug
Part 4: AMG 509 IV Combination TherapyExperimental Group · 4 Interventions: Enzalutamide, Pembrolizumab, AMG 509, Abiraterone · Intervention Types: Drug, Biological, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~1910
Pembrolizumab
2017
Completed Phase 3
~2240
Abiraterone
2012
Completed Phase 4
~1750

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: year 1, 2, and 3

Who is running the clinical trial?

AmgenLead Sponsor
1,298 Previous Clinical Trials
1,328,542 Total Patients Enrolled
12 Trials studying Prostate Cancer
4,383 Patients Enrolled for Prostate Cancer
MDStudy DirectorAmgen
840 Previous Clinical Trials
897,679 Total Patients Enrolled
7 Trials studying Prostate Cancer
4,288 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had prior taxane exposure.