Prostate Cancer Clinical Trial

Study of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Summary

Evaluate the safety and tolerability of AMG 509 in adult subjects and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Parts 1, 2, and 5: prior taxane exposure Participants with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (eg, abiraterone acetate and/or enzalutamide, apalutamide, darolutamide, bicalutamide, or equivalent) and have failed at least 1 (but not more than 2) taxane regimens including for mHSPC (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Note: A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane.

Dose exploration phase: Novel antiandrogen therapy must have been given for treatment of metastatic disease.
Dose expansion phase: participants must not have had more than 2 NHTs and 2 taxane regimens in any setting, and an additional up to 2 other systemic anti-cancer treatments are allowed (eg, anti-PD1, PARP inhibitors, radioligand therapies, sipuleucel-T, experimental agents) Note: Combinations are considered one systemic anti-cancer treatment.

Parts 4A and 4B: prior taxane exposure

Participants with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide, bicalutamide or equivalent) given for hormone-sensitive prostate cancer (HSPC) or non-metastatic CRPC and have failed up to 1 taxane regimen which must have been given for HSPC only (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen).
4A: Participants planning to receive abiraterone acetate for the first time (participants who received prior abiraterone acetate are not eligible).
4B: Participants planning to receive enzalutamide for the first time (participants who received prior enzalutamide/apalutamide or daralutamide are not eligible).

Parts 3 and 4C: no prior taxane exposure

a. Participants with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide, bicalutamide or equivalent) given in any disease setting and who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen.

Participants must have undergone bilateral orchiectomy or be on continuous androgen-deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist or antagonist.
Total serum testosterone <= 50 ng/dL or 1.7 nmol/L.

Evidence of progressive disease, defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria:

PSA level >= 1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart.
nodal or visceral progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with PCGW3 modifications.
appearance of 2 or more new lesions in bone scan.
Eastern Cooperative Oncology Group performance status of 0-1.

Adequate organ function, defined as follows:

Hematological function:

absolute neutrophil count >= 1 x 10^9/L (without growth factor support within 7 days from screening assessment).
platelet count >= 75 x 10^9/L (without platelet transfusion within 7 days from screening assessment).
hemoglobin >= 9 g/dL (90 g/L) (without blood transfusion within 7 days from screening assessment).

Renal function:

1. estimated glomerular filtration rate based on Modification of Diet in Renal Disease calculation >= 30 ml/min/1.73 m^2.

Hepatic function:

aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN) (or < 5 x ULN for participants with liver involvement).
total bilirubin (TBL) < 1.5 x ULN (or < 2 x ULN for participants with liver metastases).

Cardiac function:

left ventricular ejection fraction > 50% (2-D transthoracic echocardiogram [ECHO] is the preferred method of evaluation; multi-gated acquisition scan is acceptable if ECHO is not available).
Baseline electrocardiogram (ECG) QTcF <= 470 msec.

Exclusion Criteria:

Pathological finding consistent with pure small cell, neuroendocrine carcinoma of the prostate or any other histology different from adenocarcinoma.
Radiation therapy within 4 weeks of first dose (or local or focal radiotherapy within 2 weeks of first dose).
Untreated central nervous system (CNS) metastases or leptomeningeal disease. Participants with a history of treated CNS metastases are eligible if there is radiographic evidence of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study.
Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis); for arterial thrombosis within 12 months of AMG 509 initiation; for venous thrombosis, 6 months and stable on anti-coagulation.
Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of AMG 509 with the exception of ischemia or non-ST segment elevation myocardial infarction controlled with stent placement and confirmed by a cardiologist more than 6 months prior to first dose of AMG 509.
Any anti-cancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone (LHRH)/GnRH analogue (agonist/antagonist). Participants on a stable bisphosphonate or denosumab regimen for >= 30 days prior to enrollment are eligible.

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

459

Study ID:

NCT04221542

Recruitment Status:

Recruiting

Sponsor:

Amgen

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There are 21 Locations for this study

See Locations Near You

City of Hope National Medical Center
Duarte California, 91010, United States
University of California San Francisco
San Francisco California, 94158, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Tulane Medical Center
New Orleans Louisiana, 70112, United States
Washington University
Saint Louis Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Oncology Hematology Care Incorporated
Cincinnati Ohio, 45242, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
University of Pittsburgh Medical CenterCancer Pavillion
Pittsburgh Pennsylvania, 15232, United States
Prisma Health Upstate
Greenville South Carolina, 29605, United States
Sanford Health
Sioux Falls South Dakota, 57104, United States
Chris OBrien Lifehouse
Camperdown New South Wales, 2050, Australia
Monash Medical Centre
Clayton Victoria, 3168, Australia
National Cancer Center Hospital East
Kashiwa-shi Chiba, 277-8, Japan
Yokohama City University Hospital
Yokohama-shi Kanagawa, 236-0, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku Tokyo, 135-8, Japan
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 138-7, Korea, Republic of
National Taiwan University Hospital
Taipei , 10002, Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan , 33305, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

459

Study ID:

NCT04221542

Recruitment Status:

Recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

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