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

NCT ID: NCT03137758

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-24
• Study Completion Date: 2019-09-17

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Level 1 (50 mg) PCUR-101

Starting Dose, 3+3 Cohort Design

Group Type: EXPERIMENTAL

PCUR - 101

Intervention Type: DRUG

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

Level 2 (100 mg) PCUR-101

Group Type: EXPERIMENTAL

PCUR - 101

Intervention Type: DRUG

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

Level 3 (150 mg) PCUR-101

Group Type: EXPERIMENTAL

PCUR - 101

Intervention Type: DRUG

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

Level 4 (200 mg) PCUR-101

Group Type: EXPERIMENTAL

PCUR - 101

Intervention Type: DRUG

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

Level 5 (250 mg) PCUR-101

Group Type: EXPERIMENTAL

PCUR - 101

Intervention Type: DRUG

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

Level 6 (300 mg) PCUR-101

Group Type: EXPERIMENTAL

PCUR - 101

Intervention Type: DRUG

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

Interventions

PCUR - 101

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Pellficure Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, United States

Countries

United States

Other Identifiers

PCUR101-001

Identifier Type: -

Identifier Source: org_study_id