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Studienlocations (3 von 45)
Universitaetsklinikum Essen 45147 Essen (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsUniversitaetsklinikum Heidelberg 69120 Heidelberg (Baden-Württemberg) GermanyRekrutierend» Google-MapsKlinikum rechts der Isar der TUM 81675 Muenchen (Bayern) GermanyRekrutierend» Google-Maps
Universitaetsklinikum Muenster 48149 Muenster (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsCity of Hope National Medical Center 91010 Duarte United StatesRekrutierend» Google-MapsProvidence Saint Jude Medical Center 92835 Fullerton United StatesRekrutierend» Google-MapsUniversity of California San Francisco 94158 San Francisco United StatesRekrutierend» Google-MapsYale Cancer Center 06520 New Haven United StatesRekrutierend» Google-MapsEmory University 30322 Atlanta United StatesRekrutierend» Google-MapsIndiana University Melvin and Bren Simon Cancer Center 46202 Indianapolis United StatesRekrutierend» Google-MapsAlliance for Multispecialty Research 66204 Merriam United StatesRekrutierend» Google-MapsTulane Medical Center 70112 New Orleans United StatesAbgeschlossen» Google-MapsWashington University 63110 Saint Louis United StatesRekrutierend» Google-MapsMemorial Sloan Kettering Cancer Center 10065 New York United StatesRekrutierend» Google-MapsDuke University Medical Center 27710 Durham United StatesRekrutierend» Google-MapsOncology Hematology Care Incorporated 45242 Cincinnati United StatesRekrutierend» Google-MapsThomas Jefferson University 19107 Philadelphia United StatesRekrutierend» Google-MapsUniversity of Pittsburgh Medical Center Cancer Pavillion 15232 Pittsburgh United StatesRekrutierend» Google-MapsPrisma Health Upstate 29605 Greenville United StatesAbgeschlossen» Google-MapsSanford Health 57104 Sioux Falls United StatesRekrutierend» Google-MapsUniversity of Texas MD Anderson Cancer Center 77030 Houston United StatesRekrutierend» Google-MapsFred Hutchinson Cancer Center 98109 Seattle United StatesRekrutierend» Google-MapsChris OBrien Lifehouse 2050 Camperdown AustraliaRekrutierend» Google-MapsMonash Medical Centre 3168 Clayton AustraliaRekrutierend» Google-MapsSun Yat-sen University, Cancer Center 510060 Guangzhou ChinaRekrutierend» Google-MapsFudan University Shanghai Cancer Centre 200032 Shanghai ChinaRekrutierend» Google-MapsZhejiang Provincial Peoples Hospital 314408 Hangzhou ChinaRekrutierend» Google-MapsNational Cancer Center Hospital East 277-8577 Kashiwa-shi JapanRekrutierend» Google-MapsYokohama City University Hospital 236-0004 Yokohama-shi JapanRekrutierend» Google-MapsThe Cancer Institute Hospital of Japanese Foundation for Cancer Research 135-8550 Koto-ku JapanRekrutierend» Google-MapsSeoul National University Hospital 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsAsan Medical Center 138-736 Seoul Korea, Republic ofRekrutierend» Google-MapsHospital da Luz, SA 1500-650 Lisboa PortugalRekrutierend» Google-MapsInstituto Portugues de Oncologia do Porto Francisco Gentil, EPE 4200-072 Porto PortugalRekrutierend» Google-MapsHospital Universitari Vall d Hebron 08035 Barcelona SpainRekrutierend» Google-MapsHospital Clinic i Provincial de Barcelona 08036 Barcelona SpainRekrutierend» Google-MapsClinica Universidad de Navarra 31008 Pamplona SpainRekrutierend» Google-MapsHospital Clinico San Carlos 28040 Madrid SpainRekrutierend» Google-MapsHospital Universitario 12 de Octubre 28041 Madrid SpainRekrutierend» Google-MapsIstituto Oncologico della Svizzera Italiana 6500 Bellinzona SwitzerlandRekrutierend» Google-MapsKantonsspital Graubuenden 7000 Chur SwitzerlandRekrutierend» Google-MapsCentre Hospitalier Universitaire Vaudois 1011 Lausanne SwitzerlandRekrutierend» Google-MapsKantonsspital Sankt Gallen 9007 Sankt Gallen SwitzerlandRekrutierend» Google-MapsNational Taiwan University Hospital 10002 Taipei TaiwanRekrutierend» Google-MapsLinkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation 33305 Taoyuan TaiwanRekrutierend» Google-Maps
4. Number of participants with changes in vital signs (Time Frame - 3 years)
5. Number of participants with changes in the electrocardiogram (ECG) records (Time Frame - 3 years)
6. Number of participants with changes in the clinical laboratory tests results (Time Frame - 3 years)
Secondary outcome:
1. Maximum serum concentration (Cmax) for AMG 509 (Time Frame - 3 years): To characterize the pharmacokinetics (PK) of AMG 509
2. Time to maximum serum concentration (Tmax) for AMG 509 (Time Frame - 3 years): To characterize the pharmacokinetics (PK) of AMG 509
3. Minimum serum concentration (Cmin) for AMG 509 (Time Frame - 3 years): To characterize the pharmacokinetics (PK) of AMG 509
4. Area under the concentration-time curve (AUC) over the dosing interval for AMG 509 (Time Frame - 3 years): To characterize the pharmacokinetics (PK) of AMG 509
5. Accumulation following multiple dosing for AMG 509 (Time Frame - 3 years): To characterize the pharmacokinetics (PK) of AMG 509
6. Objective response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications (Time Frame - 3 years): To evaluate preliminary anti-tumor activity of AMG 509
7. Prostate specific antigen (PSA) response (Time Frame - 3 years): To evaluate preliminary anti-tumor activity of AMG 509
8. PSA decline of at least 50% from baseline at 12 weeks (Time Frame - Week 12): To evaluate preliminary anti-tumor activity of AMG 509
9. Duration of response (DOR) (radiographic and PSA) (Time Frame - 3 years): To evaluate preliminary anti-tumor activity of AMG 509
10. Time to progression (radiographic and PSA) (Time Frame - 3 years): To evaluate preliminary anti-tumor activity of AMG 509
11. Progression-free survival (PFS) (radiographic and PSA) (Time Frame - 3 years): To evaluate preliminary anti-tumor activity of AMG 509
12. 6 month radiographic PFS (Time Frame - 6 months): To evaluate preliminary anti-tumor activity of AMG 509
13. 1, 2, and 3-year radiographic PFS (Time Frame - Year 1, 2, and 3): To evaluate preliminary anti-tumor activity of AMG 509
14. 1, 2, and 3-year overall survival (OS) (Time Frame - Year 1, 2, and 3): To evaluate preliminary anti-tumor activity of AMG 509
15. Circulating tumor cells response (CTC0) (Time Frame - 3 years): To evaluate preliminary anti-tumor activity of AMG 509
16. Rate of circulating tumor cells (CTC) conversion (Time Frame - 3 years): To evaluate preliminary anti-tumor activity of AMG 509
17. Time to symptomatic skeletal events (Time Frame - 3 years): To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
18. Alkaline phosphatase (total, bone) (Time Frame - 3 years): To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
19. Lactate dehydrogenase (LDH) (Time Frame - 3 years): To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
20. Hemoglobin (Time Frame - 3 years): To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
21. Urine N-telopeptide (Time Frame - 3 years): To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
22. Neutrophil-to-lymphocyte ratio (Time Frame - 3 years): To evaluate preliminary anti-tumor activity of AMG 509. Measure of disease burden based on PCWG3-recommended endpoints.
Experimental: Part 1: AMG 509 Intravenous (IV) Monotherapy 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.
Experimental: Part 2: AMG 509 Subcutaneous (SC) Monotherapy 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.
Experimental: Part 3: AMG 509 IV Monotherapy in Earlier Lines of Treatment 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.
Experimental: Part 4: AMG 509 IV Combination Therapy 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.
Experimental: Part 5: AMG 509 IV Monotherapy in Outpatient Setting 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