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

NCT03137758 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: PCUR101-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Metastatic Castration-Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Toxicities and Adverse Events

  determined by type and severity using the most recent version of the CTCAE criteria

  28 days

Secondary Outcomes (2)

• Response

  up to 2 years

• Toxicities and adverse events

  up to 2 years

Other Outcomes (2)

• Measurement of Serum Cytoine IL-6

  up to 2 years

• Measurement of Urine Polyamines

  up to 2 years

Study Arms (6)

Level 1 (50 mg) PCUR-101

EXPERIMENTAL

Starting Dose, 3+3 Cohort Design

Drug: PCUR - 101

Level 2 (100 mg) PCUR-101

EXPERIMENTAL

Drug: PCUR - 101

Level 3 (150 mg) PCUR-101

EXPERIMENTAL

Drug: PCUR - 101

Level 4 (200 mg) PCUR-101

EXPERIMENTAL

Drug: PCUR - 101

Level 5 (250 mg) PCUR-101

EXPERIMENTAL

Drug: PCUR - 101

Level 6 (300 mg) PCUR-101

EXPERIMENTAL

Drug: PCUR - 101

Interventions

PCUR - 101 DRUG

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

Level 1 (50 mg) PCUR-101; Level 2 (100 mg) PCUR-101; Level 3 (150 mg) PCUR-101; Level 4 (200 mg) PCUR-101; Level 5 (250 mg) PCUR-101; Level 6 (300 mg) PCUR-101

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pellficure Pharmaceuticals, Inc: lead

Study Sites (3)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21231, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 3, 2017
• Study Start: July 24, 2017
• Primary Completion: April 3, 2019
• Study Completion: September 17, 2019
• Last Updated: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)