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

Primary Purpose

Metastatic Castration-Resistant Prostate Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PCUR - 101
Sponsored by
Pellficure Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Castration-Resistant Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University School of Medicine
  • Karmanos Cancer Institute
  • University of Wisconsin Carbone Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

Starting Dose, 3+3 Cohort Design

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Response
a combination of the revised RECIST 1.1 criteria and the guidelines for Prostate Cancer Working Group 3 (PCWG3) Criteria
Toxicities and adverse events
determined by type and severity using the most recent version of the CTCAE criteria

Full Information

First Posted
April 24, 2017
Last Updated
March 5, 2020
Sponsor
Pellficure Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03137758
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Reformulation of study drug to help reduce the pill burden as higher doses are evaluated.
Study Start Date
July 24, 2017 (Actual)
Primary Completion Date
April 3, 2019 (Actual)
Study Completion Date
September 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pellficure Pharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-Resistant Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Level 1 (50 mg) PCUR-101
Arm Type
Experimental
Arm Description
Starting Dose, 3+3 Cohort Design
Arm Title
Level 2 (100 mg) PCUR-101
Arm Type
Experimental
Arm Title
Level 3 (150 mg) PCUR-101
Arm Type
Experimental
Arm Title
Level 4 (200 mg) PCUR-101
Arm Type
Experimental
Arm Title
Level 5 (250 mg) PCUR-101
Arm Type
Experimental
Arm Title
Level 6 (300 mg) PCUR-101
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PCUR - 101
Intervention Description
PCUR-101 Capsules 25 mg are solid dosage forms for oral administration
Primary Outcome Measure Information:
Title
Toxicities and Adverse Events
Description
determined by type and severity using the most recent version of the CTCAE criteria
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Response
Description
a combination of the revised RECIST 1.1 criteria and the guidelines for Prostate Cancer Working Group 3 (PCWG3) Criteria
Time Frame
up to 2 years
Title
Toxicities and adverse events
Description
determined by type and severity using the most recent version of the CTCAE criteria
Time Frame
up to 2 years
Other Pre-specified Outcome Measures:
Title
Measurement of Serum Cytoine IL-6
Description
Blood based biomarker
Time Frame
up to 2 years
Title
Measurement of Urine Polyamines
Description
Urine based biomarker
Time Frame
up to 2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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