TALAPRO-2: Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

• Sponsor: Pfizer (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03395197
• Collaborator: Astellas Pharma Inc (Industry)
• Enrollment: 1,096
• Locations: 364
• Arms: 2
• Anticipated Duration (Months): 83.3
• Patients Per Site: 3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.

Condition or Disease	Intervention/Treatment	Phase
mCRPC	Drug: Talazoparib with enzalutamide; Drug: Placebo with enzalutamide	Phase 3

Detailed Description

Part 1 is an open-label, non-randomized, safety and PK run-in study designed to confirm the starting dose of talazoparib in combination with enzalutamide through assessment of target safety events and PK at select sites. Part 2 is a randomized, double-blind, placebo-controlled, multinational study comparing talazoparib plus enzalutamide vs. placebo plus enzalutamide in patients with mCRPC.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1096 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: To assess radiographic PFS in men with mCRPC (with no systemic treatments initiated after documentation of mCRCP) treated with talazoparib and enzalutamide vs. placebo plus enzalutamideTo assess radiographic PFS in men with mCRPC (with no systemic treatments initiated after documentation of mCRCP) treated with talazoparib and enzalutamide vs. placebo plus enzalutamide
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double-blind.
• Primary Purpose: Treatment
• Official Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
• Actual Study Start Date: Dec 18, 2017
• Anticipated Primary Completion Date: Aug 22, 2022
• Anticipated Study Completion Date: Nov 25, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combination arm Talazoparib plus enzalutamide	Drug: Talazoparib with enzalutamide; Talazoparib 0.5 mg/day plus enzalutamide 160mg/day
Active Comparator: Monotherapy arm Ezalutamide plus placebo	Drug: Placebo with enzalutamide; Placebo plus enzalutamide 160 mg/day

Outcome Measures

Primary Outcome Measures

1. Confirm the dose of Talazoparib (part 1) [Day 1 up to 28 days]

   determined based on the safety profile

2. Radiographic PFS (part 2) in unselected patients and in patients harboring DDR deficiencies [randomization up to 25 months]

   time from the date of randomization to first objective evidence of radiographic progression by blinded independent review, or death (occurring within 168 days of treatment discontinuation), whichever occurs first

Secondary Outcome Measures

1. Overall survival (part 2) in unselected patients and in patients harboring DDR deficiencies [randomization up to 47 months]

   time from randomization to death from any cause

2. Objective response in measurable soft tissue disease (part 2) in unselected patients and in patients harboring DDR deficiencies [baseline up to 6 months]

   proportion of patients with measurable soft tissue disease at baseline with objective response per RECIST 1.1

3. Duration of soft tissue response (part 2) in unselected patients and in patients harboring DDR deficiencies [baseline up to 25 months]

   duration of responses in patients with measurable soft tissue disease at baseline per RECIST 1.1

4. PSA response (part 2) in unselected patients and in patients harboring DDR deficiencies [baseline up to 25 months]

   proportion of patients with PSA response grater than or equal to 50%

5. Time to PSA progression (part 2) in unselected patients and in patients harboring DDR deficiencies [baseline up to 25 months]

   time from baseline to PSA progression

6. Time to initiation of cytotoxic chemotherapy (part 2) in unselected patients and in patients harboring DDR deficiencies [randomization up to 47 months]

   time from randomization to initiation of cytotoxic chemotherapy

7. Time to initiation of antineoplastic therapy (part 2) in unselected patients and in patients harboring DDR deficiencies [randomization up to 47 months]

   time from randomization to initiation of antineoplastic treatment

8. Time to first symptomatic skeletal event (part 2) in unselected patients and in patients harboring DDR deficiencies [randomization up to 47 months]

   time from randomization to first symptomatic skeletal event (symptomatic fractures, spinal cord compression, surgery or radiation to the bone whichever is first)

9. PFS on next line of therapy (PFS2) in unselected patients and in patients harboring DDR deficiencies [randomization up to 47 months]

   PFS2 based on investigator assessment

10. Opiate use for cancer pain (part 2) in unselected patients and in patients harboring DDR deficiencies [randomization up to 47 months]

    time from randomization to opiate use for prostate cancer pain

11. Incidence of adverse events (part 1 and 2) [Day 1 up to 26 months]

    AEs and SAEs incidence by type and severity (graded by NCI CTCAE version 4.03)

12. Pharmacokinetic assessment of talazoparib (part 1) [Week 1, 5, 9, and 13]

    plasma concentration of talazoparib

13. Pharmacokinetic assessment of talazoparib (part 2) [week 3, 5, 9 13, and 17]

    plasma concentration of talazoparib

14. Pharmacokinetic assessment of enzalutamide (part 1) [week 1, 5, 9, and 13]

    plasma concentration of enzalutamide

15. Pharmacokinetic assessment of enzalutamide (part 2) [week 3, 5, 9 13, and 17]

    plasma concentration of enzalutamide

16. Patient-reported outcome:pain symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies [baseline up to 47 months]

    change from baseline in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF)

17. Patient-reported outcome: pain symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies [baseline up to 47 months]

    time to deterioration in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF)

18. Patient-reported outcome: cancer specific global health status/QoL, functioning, and symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies [baseline up to 47 months]

    change from baseline in patient-reported Global health status/QoL per EORTC QLQ-C30

19. Patient-reported outcome: cancer specific global health status/QoL, functioning, and symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies [baseline up to 47 months]

    time to definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30

20. Patient-reported outcome: general health status (part2) in unselected patients and patients harboring DDR deficiencies [baseline up to 47 months]

    change from baseline in patient-reported general health status per EQ-5D-5L

21. Patient-reported outcome: general health status (part 2) in unselected patients and patients harboring DDR deficiencies [baseline up to 47 months]

    time to definitive deterioration in patient-reported disease-specific urinary symptoms per EORTC QLQ-PR25

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the prostate withoutsmall cell or signet cell features

Asymptomatic or mildly symptomatic metastatic castration resistant prostate cancer (mCRPC) (score on BPI-SF Question #3 must be < 4).

For enrollment into Part 2 only (optional in Part 1): assessment of DDR mutation status

Consent to a saliva sample collection for a germline comparator unless prohibited by local regulations or ethics committee decision (optional for patients in Part 1).

Surgically or medically castrated, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening.

Metastatic disease in bone documented on bone scan or in soft tissue documented on CT/MRI scan.

Progressive disease at study entry in the setting of medical or surgical castration as defined by 1 or more of the following 3 criteria:

• Prostate specific antigen (PSA) progression defined by a minimum of 2 rising PSA values from 3 consecutive assessments with an interval of at least 7 days between assessments..

• Soft tissue disease progression as defined by RECIST 1.1.

• Bone disease progression defined by Prostate Cancer Working Group 3 (PCWG3) with 2 or more new metastatic bone lesions on a whole body radionuclide bone scan.

Ongoing bisphosphonate or denosumab use prior to Day 1 (Part 1) or randomization (Part 2) is allowed but not mandatory.

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

Life expectancy ≥ 12 months as assessed by the investigator.

Able to swallow the study drug and have no known intolerance to study drugs or excipients.

Must agree to use a condom when having sex with a partner from the time of the first dose of study drug through 4 months after last dose of study treatment. Must also agree for female partner of childbearing potential to use an additional highly effective form of contraception from the time of the first dose of study treatment through 4 months after last dose of study treatment when having sex with a non pregnant female partner of childbearing potential.

Must agree not to donate sperm from the first dose of study drug to 4 months after the last dose of study drug.

Evidence of a personally signed and dated informed consent document (and molecular prescreening consent if appropriate) indicating that the patient [or a legally acceptable representative/legal guardian] has been informed of all pertinent aspects of the study.

Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

Any prior systemic cancer treatment initiated in in the non metastatic CRPC and mCRPC disease state.

Patients whose only evidence of metastasis is adenopathy below the aortic bifurcation.

Prior treatment with second-generation androgen receptor inhibitors (enzalutamide, apalutamide, and darolutamide), a PARP inhibitor, cyclophosphamide, or mitoxantrone for prostate cancer.

Prior treatment with platinum-based chemotherapy within 6 months (from the last dose) prior to Day 1 (Part 1) or randomization (Part 2), or any history of disease progression on platinum-based therapy within 6 months (from the last dose).

Treatment with cytotoxic chemotherapy, biologic therapy including sipuleucel T, or radionuclide therapy received in the castration-sensitive prostate cancer is NOT exclusionary if discontinued in the 28 days prior to Day 1 (Part 1) or randomization (Part 2).

Treatment with any investigational agent within 4 weeks before Day 1 (Part 1) or randomization (Part 2).

Prior treatment with opioids for pain related to either primary prostate cancer or metastasis within 28 days prior to Day 1 (Part 1) or randomization (Part 2).

Current use of potent P-gp inhibitors within 7 days prior to Day 1 (Part 1) or randomization (Part 2).

Major surgery (as defined by the investigator) within 2 weeks before Day 1 (Part 1) or randomization (Part 2), or palliative localized radiation therapy within 3 weeks before randomization (Part 2).

Clinically significant cardiovascular disease

Significant renal dysfunction as defined by any of the following laboratory abnormalities:

• Renal: eGFR < 30 mL/min/1.73 m2 by the MDRD equation (available via www.mdrd.com).

Patients enrolled in Part 1 only: Moderate renal impairment (eGFR 30-59 mL/min/1.73 m2) at screening.

Significant hepatic dysfunction as defined by any of the following laboratory abnormalities on screening labs:

• Total serum bilirubin >1.5 times the upper limit of normal (ULN) (>3 × ULN for patients with documented Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation).

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times ULN (>5 × ULN if liver function abnormalities are due to hepatic metastasis).

• Albumin <2.8 g/dL

Absolute neutrophil count < 1500/µL, platelets < 100,000/µL, or hemoglobin < 9 g/dL (may not have received growth factors or blood transfusions within 14 days before obtaining the hematology values at screening).

Known or suspected brain metastasis or active leptomeningeal disease.

Symptomatic or impending spinal cord compression or cauda equina syndrome.

Any history of myelodysplastic syndrome, acute myeloid leukemia, or prior malignancy except any of the following:

• Carcinoma in situ or non melanoma skin cancer

• Any prior malignancies ≥3 years before randomization with no subsequent evidence of recurrence or progression regardless of the stage.

• Stage 0 or Stage 1 cancer <3 years before randomization that has a remote probability of recurrence or progression in the opinion of the investigator

Gastrointestinal disorder affecting absorption.

Fertile male subjects who are unwilling or unable to use highly effective methods of contraception for the duration of the study and for 4 months after the last dose of investigational product.

Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.

Other acute or chronic medical (concurrent disease, infection, or comorbidity) or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that interferes with ability to participate in the study, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

History of seizure or any condition that may predispose to seizure (eg, prior cortical stroke, significant brain trauma). Also, history of loss of consciousness or transient ischemic attack within 12 months of randomization (Part 2).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alaska Urological Institute dba Alaska Clinical Research Center	Anchorage	Alaska	United States	99503
2	Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers	Chandler	Arizona	United States	85224
3	Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers	Gilbert	Arizona	United States	85297
4	Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers	Mesa	Arizona	United States	85202
5	Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers	Mesa	Arizona	United States	85206
6	Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers	Scottsdale	Arizona	United States	85260
7	Urological Associates of Southern Arizona, P.C.	Tucson	Arizona	United States	85715
8	Urological Associates of Southern Arizona, P.C.	Tucson	Arizona	United States	85741
9	Beverly Hills Cancer Center	Beverly Hills	California	United States	90211
10	South County Hematology/Oncology	Chula Vista	California	United States	91911
11	Sharp Rees-Stealy	Chula Vista	California	United States	91913
12	Glendale Adventist Medical Center	Glendale	California	United States	91206
13	Marin Cancer Care, Inc.	Greenbrae	California	United States	94904
14	Cancer Center Oncology Medical Group	La Mesa	California	United States	91942
15	Loma Linda University Cancer Center - Hematology/Oncology Clinic	Loma Linda	California	United States	92354
16	Loma Linda University Medical Center	Loma Linda	California	United States	92354
17	VA Long Beach Healthcare System	Long Beach	California	United States	90822
18	UCLA Clark Urology Center	Los Angeles	California	United States	90095
19	University of California, Irvine Medical Center	Orange	California	United States	92868
20	Stanford Cancer Institute	Palo Alto	California	United States	94304
21	Desert Hematology Oncology Medical Group, Incorporation	Rancho Mirage	California	United States	92270
22	Eisenhower Medical Center	Rancho Mirage	California	United States	92270
23	Medical Oncology Associates-SD	San Diego	California	United States	92123
24	Sharp Memorial Hospital Investigational Pharmacy	San Diego	California	United States	92123
25	Sharp Rees-Stealy	San Diego	California	United States	92123
26	Stanford Health Care	Stanford	California	United States	94305
27	University of Colorado Denver CTO/CTRC	Aurora	Colorado	United States	80045
28	University of Colorado Hospital - Anschutz Cancer Pavilion	Aurora	Colorado	United States	80045
29	University of Colorado Hospital- Anschutz Inpatient Pavilion	Aurora	Colorado	United States	80045
30	University of Colorado Hospital- Anschutz Outpatient Pavilion	Aurora	Colorado	United States	80045
31	University of Colorado Hospital	Aurora	Colorado	United States	80045
32	The Urology Center of Colorado	Denver	Colorado	United States	80211
33	Florida Cancer Specialists	Altamonte Springs	Florida	United States	32701
34	Florida Cancer Specialists	Brandon	Florida	United States	33511
35	AdventHealth Medical Group Hematology & Oncology at Celebration	Celebration	Florida	United States	34747
36	Florida Cancer Specialists	Clearwater	Florida	United States	33761
37	Florida Cancer Specialists	Daytona Beach	Florida	United States	32117
38	Florida Cancer Specialists	Fort Myers	Florida	United States	33905
39	Florida Cancer Specialists	Gainesville	Florida	United States	32605
40	AdventHealth Medical Group Hematology & Oncology at Kissimmee	Kissimmee	Florida	United States	34741
41	Lakeland Regional Health Hollis Cancer Center	Lakeland	Florida	United States	33805
42	Florida Cancer Specialists	Largo	Florida	United States	33770
43	Florida Cancer Specialists	Lecanto	Florida	United States	34461
44	Florida Cancer Specialists	New Port Richey	Florida	United States	34655
45	Florida Cancer Specialists	Ocala	Florida	United States	34471
46	Florida Cancer Specialists	Orange City	Florida	United States	32763
47	AdventHealth Hematology and Oncology	Orlando	Florida	United States	32804
48	Investigational Drug Services, Advent Health Orlando	Orlando	Florida	United States	32804
49	Florida Cancer Specialists	Orlando	Florida	United States	32806
50	Florida Cancer Specialists	Saint Petersburg	Florida	United States	33705
51	Florida Cancer Specialists	Spring Hill	Florida	United States	34608
52	Florida Cancer Specialists	Stuart	Florida	United States	34994
53	Florida Cancer Specialists	Tampa	Florida	United States	33607
54	Florida Cancer Specialists	Tavares	Florida	United States	32778
55	Florida Cancer Specialists	The Villages	Florida	United States	32159
56	Florida Cancer Specialists	Vero Beach	Florida	United States	32960
57	Florida Cancer Specialists	Wellington	Florida	United States	33414
58	Florida Cancer Specialists	West Palm Beach	Florida	United States	33401
59	Florida Cancer Specialists	Winter Park	Florida	United States	32792
60	Piedmont Cancer Institute	Atlanta	Georgia	United States	30318
61	Piedmont Cancer Institute	Fayetteville	Georgia	United States	30214
62	Piedmont Cancer Institute	Newnan	Georgia	United States	30265
63	Southeastern Regional Medical Center	Newnan	Georgia	United States	30265
64	Cook County Health (CCH)	Chicago	Illinois	United States	60612
65	John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy	Chicago	Illinois	United States	60612
66	AMITA Health Adventist Medical Center Hinsdale	Hinsdale	Illinois	United States	60521
67	AMITA Health Cancer Institute	Hinsdale	Illinois	United States	60521
68	Midwestern Regional Medical Center	Zion	Illinois	United States	60099
69	Clark Memorial Hospital Radiology	Jeffersonville	Indiana	United States	47130
70	First Urology, PSC	Jeffersonville	Indiana	United States	47130
71	University of Iowa Hospital and Clinics	Iowa City	Iowa	United States	52242
72	The University of Kansas Clinical Research Center	Fairway	Kansas	United States	66205
73	The University of Kansas Cancer Center	Westwood	Kansas	United States	66205
74	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
75	VA Saint Louis Healthcare System	Saint Louis	Missouri	United States	63106
76	GU Research Network/Urology Cancer Center	Omaha	Nebraska	United States	68130
77	Clara Maass Medical Center	Belleville	New Jersey	United States	07109
78	New Jersey Cancer Care and Blood Disorders	Belleville	New Jersey	United States	07109
79	University Radiology	Nutley	New Jersey	United States	07110
80	New Jersey Urology, LLC	Voorhees	New Jersey	United States	08043
81	Urology Group of New Mexico	Albuquerque	New Mexico	United States	87109
82	San Juan Oncology Associates	Farmington	New Mexico	United States	87401
83	Montefiore Medical Center - Montefiore Medical Park	Bronx	New York	United States	10461
84	Premier Medical Group of the Hudson Valley PC	Poughkeepsie	New York	United States	12603
85	Associated Medical Professionals of New York, PLLC	Syracuse	New York	United States	13210
86	TriState urologic Services PSC Inc., dba The Urology Group	Cincinnati	Ohio	United States	45212
87	Clinical Research Solutions	Middleburg Heights	Ohio	United States	44130
88	Stephenson Cancer Center	Oklahoma City	Oklahoma	United States	73104
89	Kaiser Sunnyside Medical Center	Clackamas	Oregon	United States	97015-9303
90	Providence Cancer Institute Clackamas Clinic	Clackamas	Oregon	United States	97015
91	Kaiser Westside Medical Center	Hillsboro	Oregon	United States	97124
92	Providence Cancer Institute Newberg Clinic	Newberg	Oregon	United States	97132
93	Providence Cancer Institute Franz Clinic	Portland	Oregon	United States	97213
94	Providence Oncology and Hematology Care Clinic - Westside	Portland	Oregon	United States	97225
95	Kaiser Permanente Northwest	Portland	Oregon	United States	97227
96	UPMC Hillman Cancer Center - Altoona	Altoona	Pennsylvania	United States	16601
97	UPMC Hillman Cancer Center - Upper St. Clair	Bethel Park	Pennsylvania	United States	15102
98	UPMC Hillman Cancer Center - Arnold Palmer - Mt View	Greensburg	Pennsylvania	United States	15601
99	Keystone Urology Specialists	Lancaster	Pennsylvania	United States	17604
100	UPMC Hillman Cancer Center - Monroeville	Monroeville	Pennsylvania	United States	15146
101	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania	United States	15232
102	UPMC Hillman Cancer Center - Passavant (HOA)	Pittsburgh	Pennsylvania	United States	15237
103	UPMC Hillman Cancer Center - Passavant (OHA)	Pittsburgh	Pennsylvania	United States	15237
104	UPMC Hillman Cancer Center - Northwest	Seneca	Pennsylvania	United States	16346
105	UPMC Hillman Cancer Center - Uniontown	Uniontown	Pennsylvania	United States	15401
106	UPMC Hillman Cancer Center - Washington	Washington	Pennsylvania	United States	15301
107	Carolina Urologic Research Center	Myrtle Beach	South Carolina	United States	29572
108	Sarah Cannon Research Institute	Chattanooga	Tennessee	United States	37404
109	Tennessee Oncology, PLLC	Chattanooga	Tennessee	United States	37404
110	Tennesse Oncology, PLLC	Cleveland	Tennessee	United States	37311
111	Urology Associates P.C.	Nashville	Tennessee	United States	37209
112	The Vanderbilt Clinic	Nashville	Tennessee	United States	37232
113	Vanderbuilt University Medical Center, Department of Urology	Nashville	Tennessee	United States	37232
114	Urology Austin PLLC	Austin	Texas	United States	78745
115	Rio Grande Urology, P.A.	El Paso	Texas	United States	79912
116	Houston Metro Urology	Houston	Texas	United States	77027
117	Urology Austin, PLLC	Round Rock	Texas	United States	78681
118	Baylor Scott & White Medical Center - Temple	Temple	Texas	United States	76508
119	Farmington Health Center -University of Utah	Farmington	Utah	United States	84025
120	Huntsman Cancer Hospital	Salt Lake City	Utah	United States	84112
121	University of Utah, Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112
122	Redwood Health Center-University of Utah	Salt Lake City	Utah	United States	84119
123	South Jordan Health Center -University of Utah	South Jordan	Utah	United States	84095
124	Inova Schar Cancer Institute Infusion Pharmacy	Fairfax	Virginia	United States	22031
125	Inova Schar Cancer Institute	Fairfax	Virginia	United States	22031
126	Swedish Cancer Institute	Seattle	Washington	United States	98104
127	Swedish Medical Center	Seattle	Washington	United States	98122
128	University of Wisconsin Clinical Science Center	Madison	Wisconsin	United States	53792
129	University of Wisconsin Hospital & Clinics	Madison	Wisconsin	United States	53792
130	Centro de Investigacion Pergamino SA - Clinica Pergamino SA	Pergamino	Buenos Aires	Argentina	B2700CPM
131	Instituto de Oncologia de Rosario	Rosario	Santa FE	Argentina	S2000KZE
132	Hospital Británico de Buenos Aires	Caba		Argentina	C1280AEB
133	Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" Cemic	Caba		Argentina	C1431FWO
134	Clinica Universitaria Reina Fabiola	Cordoba		Argentina	X5004FHP
135	Hospital Privado Centro Medico de Cordoba	Cordoba		Argentina	X5016KEH
136	Chris O'Brien Lifehouse	Camperdown	New South Wales	Australia	2050
137	St Vincent's Hospital Sydney	Darlinghurst	New South Wales	Australia	2010
138	Port Macquarie Base Hospital	Port Macquarie	New South Wales	Australia	2444
139	ICON Cancer Centre Wesley	Auchenflower	Queensland	Australia	4066
140	River City Pharmacy	Auchenflower	Queensland	Australia	4066
141	Princess Alexandra Hospital	Brisbane	Queensland	Australia	4102
142	ICON Cancer Centre Chermside	Chermside	Queensland	Australia	4032
143	ICON Cancer Centre South Brisbane	South Brisbane	Queensland	Australia	4101
144	Integrated Clinical Oncology Network Pty Ltd (ICON)	South Brisbane	Queensland	Australia	4101
145	ICON Cancer Centre Southport	Southport	Queensland	Australia	4215
146	Peter MacCallum Cancer Centre	Melbourne	Victoria	Australia	3000
147	Peter MacCallum Cancer Centre	North Melbourne	Victoria	Australia	3051
148	AZ Klina	Brasschaat		Belgium	2930
149	A.Z. Sint-Lucas	Gent		Belgium	9000
150	UZ Gent	Gent		Belgium	9000
151	AZ Groeninge	Kortrijk		Belgium	8500
152	Clinique Saint-Pierre Ottignies	Ottignies		Belgium	1340
153	CHU UCL Namur site Godinne	Yvoir		Belgium	5530
154	Instituto Nacional de Câncer José de Alencar Gomes da Silva - INCA	Rio de Janeiro	RJ	Brazil	20230-130
155	Instituto Nacional de Câncer José de Alencar Gomes da Silva - INCA	Rio de Janeiro	RJ	Brazil	20231-050
156	Hospital Universitario Pedro Ernesto-Centro de Pesquisas (CEPUSA)	Rio de Janeiro	RJ	Brazil	20551-030
157	Hospital CopaDor	Rio de Janeiro	RJ	Brazil	22031-011
158	Hospital Gloria D'Or	Rio de Janeiro	RJ	Brazil	22211-230
159	Oncologia D'Or	Rio de Janeiro	RJ	Brazil	22251-040
160	Instituto D'Or de Pesquisa e Ensino	Rio de Janeiro	RJ	Brazil	22281-100
161	Oncologia D'Or	Rio de Janeiro	RJ	Brazil	22291-110
162	Associacao Hospital de Caridade de Ijui	Ijui	RS	Brazil	98700-000
163	Sociedade Beneficencia e Caridade de Lajeado - Hospital Bruno Born	Lajeado	RS	Brazil	95900-022
164	Centro de Pesquisa Clinica de Oncologia e Hematologia/Hospital Mae de Deus	Porto Alegre	RS	Brazil	90110-000
165	Centro de Pesquisa Clinica de Oncologia e Hematologia/Hospital Mae de Deus	Porto Alegre	RS	Brazil	90110-270
166	Centro de Pesquisa Clinica em Oncologia - Hospital Sao Lucas da Pontificia Universidade Catolica	Porto Alegre	RS	Brazil	90610-000
167	MedPlex Eixo Norte	Porto Alegre	RS	Brazil	91010-004
168	Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao	Porto Alegre	RS	Brazil	91350-200
169	Fundacao Pio XII - Hospital de Cancer de Barretos	Barretos	SP	Brazil	14784-400
170	Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Oncologia (CEPHO)	Santo Andre	SP	Brazil	09060-650
171	Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Oncologia (CEPHO)	Santo Andre	SP	Brazil	09060-870
172	Instituto do Cancer do Estado de Sao Paulo - ICESP	Sao Paulo	SP	Brazil	01246-000
173	Instituto do Cancer do Estado de Sao Paulo-ICESP-Nucleo de Pesquisa	Sao Paulo	SP	Brazil	01246-000
174	Hospital Alemão Oswaldo Cruz	Sao Paulo	SP	Brazil	01327-001
175	Tom Baker Cancer Centre - Alberta Health Services	Calgary	Alberta	Canada	T2N 4N2
176	The Ottawa Hospital Cancer Center	Ottawa	Ontario	Canada	K1H 8L6
177	Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean	Chicoutimi	Quebec	Canada	G7H 5H6
178	CHUM - Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec	Canada	H2X 3E4
179	Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2
180	Centre integre universitaire de sante et de services sociaux de l'Estrie	Sherbrooke	Quebec	Canada	J1H 5N4
181	Sociedad Prosalud Montes y Orlandi Ltda. Fantasy name (Orlandi Oncologia)	Santiago	Metropolitana	Chile	7500713
182	Centro de Investigacion Clinica del Sur	Temuco	Region DE LA Araucania	Chile	4781156
183	Sociedad de Investigaciones Medicas Ltda (SIM)	Temuco	Region DE LA Araucania	Chile	4810469
184	Sociedad de Investigaciones Medicas Ltda (SIM)	Temuco	Region DE LA Araucania	Chile	4810561
185	Centro de Investigaciones Clinicas Vina del Mar	Vina del Mar	Valparaiso	Chile	2540488
186	Centro de Investigaciones Clinicas Vina del Mar	Vina del Mar	Valparaiso	Chile	2540634
187	The First affiliated Hospital of Anhui Medical University	Hefei	Anhui	China	230022
188	Peking University First Hospital / Urology Department	Beijing	Beijing	China	100034
189	Beijing Cancer Hospital	Beijing	Beijing	China	100142
190	Peking University Third Hospital	Beijing	Beijing	China	100191
191	Beijing Hospital	Beijing	Beijing	China	100730
192	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	China	350005
193	First Affiliated Hospital of Xiamen University	Xiamen	Fujian	China	361003
194	Union Hospital, Tongji Medical College of Huazhong University of Science & Technology	Wuhan	Hubei	China	430022
195	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430030
196	The First People's Hospital of Lianyungang	Lianyungang	Jiangsu	China	222061
197	Nanjing First Hospital	Nanjing	Jiangsu	China	210006
198	Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210008
199	Nantong Tumor Hospital	Nantong	Jiangsu	China	226000
200	Second Affiliated Hospital of Suzhou University	Suzhou	Jiangsu	China	215004
201	Wuxi People's Hospital	Wuxi	Jiangsu	China	214023
202	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China	330006
203	Jilin Cancer Hospital	Changchun	Jilin	China	130000
204	Zhongshan Hospital Fudan University	Shanghai	Shanghai	China	200032
205	Shanghai General Hospital	Shanghai	Shanghai	China	200080
206	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi	China	710061
207	West China Hospital of Sichuan University	Chengdu	Sichuan	China	610041
208	Yunnan Cancer Hospital	Kunming	Yunnan	China	650118
209	The First Affiliated Hospital College of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310003
210	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang	China	310014
211	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310022
212	Ningbo First Hospital	Ningbo	Zhejiang	China	315010
213	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing		China	100021
214	Chongqing University Cancer Hospital	Chongqing		China	400030
215	Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai		China	200025
216	Fudan University Cancer Hospital, Deptartment of Urology	Shanghai		China	200032
217	Shanghai Tenth People's Hospital	Shanghai		China	200072
218	The Fifth People's Hospital of Shanghai, Fudan University	Shanghai		China	201100
219	The Second Hospital of Tianjin Medical University	Tianjin		China	300211
220	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou		China	325035
221	Fakultní nemocnice Hradec Králové	Hradec Kralove		Czechia	500 05
222	Fakultni nemocnice Ostrava	Ostrava-Poruba		Czechia	708 52
223	Multiscan s.r.o.	Pardubice		Czechia	532 03
224	Fakultní nemocnice Královské Vinohrady	Praha 10		Czechia	100 34
225	HUS Helsinki University Hospital	Helsinki		Finland	00029
226	Docrates Cancer Center	Helsinki		Finland	00180
227	OYS apteekki	Kempele		Finland	90440
228	Kuopio University Hospital	Kuopio		Finland	70029
229	Kuopio University Hospital	Kuopio		Finland	70210
230	Oulun yliopistollinen sairaala	Oulu		Finland	90220
231	Tampere University Hospital	Tampere		Finland	33520
232	Turku University Hospital	Turku		Finland	20520
233	Centre d'Oncologie du Pays-Basque	Bayonne		France	64100
234	Clinique Ramsay Belharra	Bayonne		France	64100
235	Hopital Saint Andre - CHU de Bordeaux	Bordeaux		France	33075
236	CHD Vendée	LA ROCHE SUR YON cedex 9		France	85925
237	Clinique Victor Hugo-Centre Jean Bernard	Le Mans		France	72000
238	Clinique Victor Hugo	Le Mans		France	72015 Cedex 02
239	Centre Leon Berard	Lyon Cedex 08		France	69373
240	Centre Léon Bérard	Lyon CEDEX 08		France	69373
241	CHU Montpellier-Hopital Saint Eloi	Montpellier cedex 5		France	34295
242	Hopital Europeen Georges Pompidou	Paris Cedex 15		France	75908
243	Hopital Saint-Louis	Paris		France	75010
244	Clinique Sainte Anne	Strasbourg		France	67000
245	Hopitaux Universitaires de Strasbourg - ICANS	Strasbourg		France	67200
246	Hopital Foch	Suresnes Cedex		France	92151
247	Hopital Foch	Suresnes		France	92150
248	Institut Gustave Roussy	VILLEJUIF cedex		France	94805
249	Universitatsklinikum Erlangen AURONTE/Medizinische Klinik 5	Erlangen	Bayern	Germany	91054
250	Universitaetsklinikum Duesseldorf	Duesseldorf		Germany	40225
251	Universitaetsklinikum Erlangen, Urologische und Kinderurologische Klinik	Erlangen		Germany	91054
252	Universitaetsklinikum Hamburg-Eppendorf	Hamburg		Germany	20246
253	Universitaetsklinik Heidelberg	Heidelberg		Germany	69120
254	Diagnostikzentrum	Kirchheim		Germany	73230
255	Universitaetsklinikum Muenster	Muenster		Germany	48149
256	Studienpraxis Urologie	Nuertingen		Germany	72622
257	Semmelweis Egyetem Urologiai Klinika	Budapest		Hungary	1082
258	Országos Onkológiai Intézet	Budapest		Hungary	1122
259	Uzsoki Utcai Korhaz	Budapest		Hungary	1145
260	Uzsoki Utcai Kórház	Budapest		Hungary	1145
261	Debreceni Egyetem Klinikai Kozpont	Debrecen		Hungary	4032
262	Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intezet	Pecs		Hungary	7624
263	Rambam Health Care Campus	Haifa		Israel	3109601
264	Shaare Zedek Medical Center	Jerusalem		Israel	9103102
265	Tel Aviv Sourasky Medical Center	Tel Aviv		Israel	6423906
266	Azienda Ospedaliero-Universitaria Policlinico Sant' Orsola Malpighi	Bologna	BO	Italy	40138
267	ASST di Cremona	Cremona	CR	Italy	26100
268	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS	Meldola	FC	Italy	47014
269	Azienda Ospedaliera S. Maria	Terni	TN	Italy	05100
270	Ospedale Santa Chiara	Trento	TN	Italy	38122
271	AOU San Luigi Gonzaga	Orbassano	TO	Italy	10043
272	ASST-Spedali Civili di Brescia	Brescia		Italy	25123
273	A.O.R.N. "A. Cardarelli"	Napoli		Italy	80131
274	Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli	Napoli		Italy	80131
275	Nagoya University Hospital	Nagoya	Aichi	Japan	466-8560
276	Hirosaki University School of Medicine & Hospital	Hirosaki	Aomori	Japan	036-8563
277	National Cancer Center Hospital East	Kashiwa	Chiba	Japan	277-8577
278	National Hospital Organization Shikoku Cancer Center	Matsuyama	Ehime	Japan	791-0280
279	National Hospital Organization Kure Medical Center and Chugoku Cancer Center	Kure	Hiroshima	Japan	737-0023
280	National Hospital Organization Hokkaido Cancer Center	Sapporo	Hokkaido	Japan	003-0804
281	Hokkaido University Hospital	Sapporo	Hokkaido	Japan	060-8648
282	Kanazawa University Hospital	Kanazawa	Ishikawa	Japan	920-8641
283	Yokohama City University Medical Center	Yokohama	Kanagawa	Japan	232-0024
284	Yokosuka Kyosai Hospital	Yokosuka	Kanagawa	Japan	238-8558
285	Osaka International Cancer Institute	Osaka-shi	Osaka	Japan	5418567
286	Kindai University Hospital	Osakasayama	Osaka	Japan	589-8511
287	Osaka University Hospital	Suita	Osaka	Japan	565-0871
288	Hamamatsu University School of Medicine, University Hospital	Hamamatsu	Shizuoka	Japan	431-3192
289	National Hospital Organization Tokyo Medical Center	Meguro-ku	Tokyo	Japan	152-8902
290	Keio University Hospital	Shinjuku-ku	Tokyo	Japan	160-8582
291	Chiba Cancer Center	Chiba		Japan	260-8717
292	National Hospital Organization Kyushu Cancer Center	Fukuoka		Japan	811-1395
293	Kagoshima University Hospital	Kagoshima		Japan	890-8520
294	National Hospital Organization Kumamoto Medical Center	Kumamoto		Japan	860-0008
295	Tokushima University Hospital	Tokushima		Japan	770-8503
296	Yamagata Prefectural Central Hospital	Yamagata		Japan	990-2292
297	Yamagata University Hospital	Yamagata		Japan	990-9585
298	Clinical Trial Pharmacy, National Cancer Center	Goyang-si	Gyeonggi-do	Korea, Republic of	10408
299	National Cancer Center	Goyang-si	Gyeonggi-do	Korea, Republic of	10408
300	Pusan National University Hospital	Busan		Korea, Republic of	49241
301	Kyungpook National University Chilgok Hospital	Daegu		Korea, Republic of	41404
302	Seoul National University Hospital	Seoul		Korea, Republic of	03080
303	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722
304	Asan Medical Center	Seoul		Korea, Republic of	05505
305	Cancer Center Clinical Trial, Asan Medical Center	Seoul		Korea, Republic of	05505
306	Clinical Trials Center Pharmacy	Seoul		Korea, Republic of	06351
307	Samsung Medical Center	Seoul		Korea, Republic of	06351
308	Clinical Trial Pharmacy, The Catholic University of Korea	Seoul		Korea, Republic of	06591
309	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul		Korea, Republic of	06591
310	Tauranga Urology Research Limited	Tauranga	BAY OF Plenty	New Zealand	3112
311	Canterbury District Health Board	Christchurch	Canterbury	New Zealand	8011
312	Waikato Hospital	Hamilton	Waikato	New Zealand	3204
313	Auckland City Hospital	Auckland		New Zealand	1023
314	Sykehusapoteket Ostfold, Kalnes	Gralum		Norway	1712
315	Ostfold County Hospital, Kalnes	Gralum		Norway	1714
316	Akershus University Hospital	Lorenskog		Norway	1478
317	Oslo University Hospital -Ullevål & Radiumhospitalet	Oslo		Norway	0379
318	St. Olavs Hospital, Trondheim University Hospital	Trondheim		Norway	7030
319	Clinica Monte Carmelo S.C.R.LTDA.	Arequipa		Peru
320	Hospital Militar Central "Coronel Luis Arias Schreiber"	Lima		Peru	Lima 11
321	Clinica Internacional Sede San Borja	Lima		Peru	Lima 41
322	Clinica Oncosalud	Lima		Peru	Lima 41
323	Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. Markiewicza	Brzozow		Poland	36-200
324	Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii	Gdynia		Poland	81-519
325	Przychodnia Lekarska "Komed" Roman Karaszewski	Konin		Poland	62-500
326	Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina	Otwock		Poland	05-400
327	City Clinic Sp. z o.o.	Warszawa		Poland	02-473
328	NZOZ Szpital Mazovia; Oddzial urologiczny	Warszawa		Poland	02-797
329	Centro Clínico Académico - Braga, Associação (2CABraga)	Braga		Portugal	4710-243
330	Instituto Português Oncologia de Coimbra Francisco Gentil - E.P.E	Coimbra		Portugal	3000-075
331	Fundação Champalimaud	Lisboa		Portugal	1400-038
332	Hospital da Luz Lisboa	Lisboa		Portugal	1500-650
333	Centro Hospitalar do Porto - Hospital de Santo Antonio	Porto		Portugal	4099-001
334	Instituto Português de Oncologia do Porto Francisco Gentil	Porto		Portugal	4200-072
335	Cancercare Langenhoven Drive Oncology Centre	Port Elizabeth	Eastern CAPE	South Africa	6045
336	Wits Clinical Research Charlotte Maxeke Johannesburg Academic Hospital (CMJAH), Clinical Trial Site	Johannesburg	Gauteng	South Africa	2193
337	Wits Clinical Research	Johannesburg	Gauteng	South Africa	2193
338	The Medical Oncology Centre of Rosebank	Johannesburg	Gauteng	South Africa	2196
339	Cancercare Rondebosch Oncology	Cape Town	Western CAPE	South Africa	7700
340	Outeniqua Cancercare Oncology Unit	George	Western CAPE	South Africa	6530
341	Cape Town Oncology Trials	Kraaifontein, Cape Town	Western CAPE	South Africa	7570
342	Hospital Clinico Universitario de Santiago de Compostela	Santiago de Compostela	A Coruna	Spain	15706
343	Hospital General Universitario de Elche	Elche	Alicante	Spain	03203
344	Institut Catala d'Oncologia - ICO L'Hospitalet	L'Hospitalet de Llobregat	Barcelona	Spain	08908
345	Corporacio Sanitaria i Universitaria Parc Tauli	Sabadell	Barcelona	Spain	08208
346	Hospital Universitario Virgen de la Arrixaca	El Palmar	Murcia	Spain	30120
347	Hospital Universitari Vall d'Hebron	Barcelona		Spain	08035
348	Hospital Clinic de Barcelona	Barcelona		Spain	08036
349	Hospital Universitario La Princesa	Madrid		Spain	28006
350	Hospital General Universitario Gregorio Maranon	Madrid		Spain	28009
351	MD Anderson Cancer Center	Madrid		Spain	28033
352	Hospital Universitario 12 De Octubre	Madrid		Spain	28041
353	Klinisk Provningsenhet (KPE) Onkologi	Goteborg		Sweden	413 45
354	Patientomrade Backencancer, Tema Cancer	Stockholm		Sweden	171 76
355	Cancercentrum	Umeå		Sweden	901 85
356	University Hospitals Plymouth NHS Trust	Plymouth	Devon	United Kingdom	PL6 8DH
357	The Clatterbridge Cancer Centre NHS Foundation Trust	Bebington	Wirral	United Kingdom	CH63 4JY
358	Royal Cornwall Hospitals NHS Trust	Cornwall		United Kingdom	TR1 3LJ
359	NHS Greater Glasgow and Clyde	Glasgow		United Kingdom	G12 0YN
360	The Clatterbridge Cancer Centre - Liverpool	Liverpool		United Kingdom	L7 8YA
361	Imperial College Healthcare NHS Trust	London		United Kingdom	W12 0HS
362	Imperial College Healthcare NHS Trust	London		United Kingdom	W2 1NY
363	Imperial College Healthcare NHS Trust, Charing Cross Hospital	London		United Kingdom	W6 8RF
364	Oxford University Hospitals NHS Trust	Oxford		United Kingdom	OX3 7LE

Sponsors and Collaborators

• Pfizer
• Astellas Pharma Inc

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03395197
• Other Study ID Numbers: C3441021; 2017-003295-31; TALAPRO-2
• First Posted: Jan 10, 2018
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: mCRPC (metastatic castration-resistant prostate cancer)
• Additional relevant MeSH terms: Talazoparib

Study Results

No Results Posted as of Aug 5, 2022