A Phase I Study of PCUR-101 in Combination With Androgen Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/22/2018
Start Date:July 24, 2017
End Date:December 2019

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This is an open label, non-randomized, Phase I, dose escalation/dose expansion study of
PCUR-101 in combination with androgen suppression therapy in the patients with metastatic
CRPC


Inclusion Criteria:

- histologically confirmed diagnosis of metastatic CRPC

- standard of care androgen deprivation treatment

- castrate serum level of testosterone of ≤ 50 ng/dL (≤ 1.73 mmol/L)

- progressive disease while receiving androgen deprivation therapy

- previously treated with abiraterone, enzalutamide alone or in combination AND must
have demonstrated evidence of objective progression as per PCWG3 criteria

- adequate hematologic, renal and hepatic function

- KPS of ≥ 70 or ECOG of 0 to 1

Exclusion Criteria:

- pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer
histology

- use of opiate analgesics for prostate cancer pain within 4 week of treatment start

- more than one sequential second generation AR-directed therapy

- received cytotoxic chemotherapy for either metastatic HSPC or CRPC within the last 12
weeks or other investigational agents within 4 weeks

- history of bleeding disorder

- history of seizure disorder

- concomitant use of therapeutic anticoagulation

- history of or current cardiac issues

- received external beam radiation therapy within 4 weeks

- CTCAE Grade > 2 neuropathy
We found this trial at
3
sites
Detroit, Michigan 48201
Principal Investigator: Ulka Vaishampayan, MD
Phone: 313-576-9386
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Principal Investigator: Channing Paller, MD
Phone: 410-955-0009
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Christos Kyriakopoulos, MD
Phone: 608-263-7107
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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Madison, WI
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