ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03137758
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Pellficure Pharmaceuticals, Inc

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

Condition or disease Intervention/treatment Phase
Metastatic Castration-Resistant Prostate Cancer Drug: PCUR - 101 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 24, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. Toxicities and Adverse Events [ Time Frame: 28 days ]
    determined by type and severity using the most recent version of the CTCAE criteria


Secondary Outcome Measures :
  1. Response [ Time Frame: up to 2 years ]
    a combination of the revised RECIST 1.1 criteria and the guidelines for Prostate Cancer Working Group 3 (PCWG3) Criteria

  2. Toxicities and adverse events [ Time Frame: up to 2 years ]
    determined by type and severity using the most recent version of the CTCAE criteria


Other Outcome Measures:
  1. Measurement of Serum Cytoine IL-6 [ Time Frame: up to 2 years ]
    Blood based biomarker

  2. Measurement of Urine Polyamines [ Time Frame: up to 2 years ]
    Urine based biomarker



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137758


Locations
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21231
Contact: Sandy Moore Cooper    410-955-0009    moorsa@jhmi.edu   
Principal Investigator: Channing Paller, MD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Anita Kadoo    313-576-9386    kadooa@karmanos.org   
Principal Investigator: Ulka Vaishampayan, MD         
United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Contact: Jamie Wiepz    608-263-7107    wiepz2@wisc.edu   
Principal Investigator: Christos Kyriakopoulos, MD         
Sponsors and Collaborators
Pellficure Pharmaceuticals, Inc

Responsible Party: Pellficure Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT03137758     History of Changes
Other Study ID Numbers: PCUR101-001
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs