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

Metastatic Castration-Resistant Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03137758
• Other study ID #: PCUR101-001
• Status: Terminated
• Phase: Phase 1
• Start date: July 24, 2017
• Est. completion date: September 17, 2019

Study information

• Verified date: March 2020
• Source: Pellficure Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: September 17, 2019
• Est. primary completion date: April 3, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Castration-Resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• PCUR - 101
PCUR-101 Capsules 25 mg are solid dosage forms for oral administration

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Pellficure Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measurement of Serum Cytoine IL-6	Blood based biomarker	up to 2 years
Other	Measurement of Urine Polyamines	Urine based biomarker	up to 2 years
Primary	Toxicities and Adverse Events	determined by type and severity using the most recent version of the CTCAE criteria	28 days
Secondary	Response	a combination of the revised RECIST 1.1 criteria and the guidelines for Prostate Cancer Working Group 3 (PCWG3) Criteria	up to 2 years
Secondary	Toxicities and adverse events	determined by type and severity using the most recent version of the CTCAE criteria	up to 2 years