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

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

Study Overview

• Status: Terminated
• Conditions: Metastatic Castration-Resistant Prostate Cancer
• Intervention / Treatment: Drug: PCUR - 101

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins University School of Medicine
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Level 1 (50 mg) PCUR-101; Starting Dose, 3+3 Cohort Design	Drug: PCUR - 101; PCUR-101 Capsules 25 mg are solid dosage forms for oral administration
Experimental: Level 2 (100 mg) PCUR-101	Drug: PCUR - 101; PCUR-101 Capsules 25 mg are solid dosage forms for oral administration
Experimental: Level 3 (150 mg) PCUR-101	Drug: PCUR - 101; PCUR-101 Capsules 25 mg are solid dosage forms for oral administration
Experimental: Level 4 (200 mg) PCUR-101	Drug: PCUR - 101; PCUR-101 Capsules 25 mg are solid dosage forms for oral administration
Experimental: Level 5 (250 mg) PCUR-101	Drug: PCUR - 101; PCUR-101 Capsules 25 mg are solid dosage forms for oral administration
Experimental: Level 6 (300 mg) PCUR-101	Drug: PCUR - 101; PCUR-101 Capsules 25 mg are solid dosage forms for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicities and Adverse Events	determined by type and severity using the most recent version of the CTCAE criteria	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Toxicities and adverse events	determined by type and severity using the most recent version of the CTCAE criteria	up to 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Serum Cytoine IL-6	Blood based biomarker	up to 2 years
Measurement of Urine Polyamines	Urine based biomarker	up to 2 years

Collaborators and Investigators

• Sponsor: Pellficure Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2017
• Primary Completion (Actual): April 3, 2019
• Study Completion (Actual): September 17, 2019

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PCUR101-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No