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Study of PCUR-101 in Combination With ADT in Patients With mCRPC

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

PCUR-101

Dutasteride 0.5 mg

Abiraterone and Prednisone

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria:

Histologically confirmed diagnosis of prostate cancer
Demonstrates metastatic CRPC
Castrate level of serum testosterone at screening
Adequate hematologic, renal, and hepatic function
ECOG status ≤1
Life expectancy of at least 3 months
No more than one prior course of cytotoxic chemotherapy

Exclusion Criteria:

Pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology
Visceral metastasis excluding lymph nodes
Use of opiate analgesics for prostate cancer pain or non-cancer pain
other investigational agents or concurrent anticancer therapy other than standard androgen deprivation therapy within 4 weeks
History of bleeding disorder
History of seizure disorder
Concomitant use of warfarin
Prior exposure to PCUR-101
History of myocardial infarction, arterial thrombotic events, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia
Received wide-field external beam radiation therapy within 4 weeks
Moderate to severe neuropathy

Sites / Locations

University of MichiganRecruiting
Nebraska Cancer SpecialistRecruiting
St. George Private Hospital
Sydney South West Private Hospital
Southern Oncology Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

PCUR-101 Dose Escalation

PCUR-101 Dose Expansion Cohort 1

PCUR-101 Dose Expansion Cohort 2

PCUR-101 Dose Expansion Cohort 3

Arm Description

PCUR-101 dosed orally once per day in 28 day cycles. Patients will be enrolled into escalating dose levels during the dose escalation phase

PCUR-101 dosed orally once per day in 28 day cycles

PCUR-101 in combination with dutasteride dosed orally once per day in 28 day cycles

PCUR-101 dosed orally once per day in combination with abiraterone (once per day) and prednisone (twice per day) in 28 day cycles

Outcomes

Primary Outcome Measures

Occurrence of Dose Limiting Toxicity

Incidence of Adverse Adverse Events

Secondary Outcome Measures

Determination of pharmacokinetic parameters - Tmax

time to peak concentrations of PCUR-101

Determination of pharmacokinetic parameters - Cmax

peak concentrations of PCUR-101

Determination of pharmacokinetic parameters - T1/2

time from maximum concentration PCUR-101 to a reduction of plasma concentration by 50%

Preliminary Evidence of efficacy/anti tumor activity - PSA levels

as assessed by PSA changes

Preliminary Evidence of efficacy/anti tumor activity - RECIST

as assessed by RECIST 1.1 criteria

Full Information

NCT ID

NCT04677855

First Posted

December 14, 2020

Last Updated

January 6, 2023

Sponsor

Pellficure Pharmaceuticals, Inc

1. Study Identification

Unique Protocol Identification Number

NCT04677855

Brief Title

Study of PCUR-101 in Combination With ADT in Patients With mCRPC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 30, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

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

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is an open label, non-randomized, Phase I, dose escalation/dose expansion study in cohorts of patients with metastatic CRPC at Screening. Dose escalation uses a 3+3 design to determine the maximum tolerated dose (MTD). Once the MTD is defined, the dose expansion phase is used to define the recommended phase 2 dose.

Detailed Description

Dose Escalation Phase: Eligible patients will enter the study and start receiving daily doses of PCUR-101 during Cycle 1. Subsequent dose cohorts will receive the next higher dose of PCUR-101 according to a 3 + 3 design until the MTD is determined. Patients may remain on these treatment cycles if they do not progress or experience any dose limiting toxicities (DLTs). Dose Expansion Phase: Once the MTD has been determined, approximately 18 patients in 3 cohorts will be enrolled for further evaluations of safety, PK, and preliminary clinical activity during successive 28-day cycles in the dose expansion phase: Expansion Cohort 1 will receive PCUR-101 at the MTD, Expansion Cohort 2 will receive PCUR-101 at one dose level lower than the MTD and dutasteride once daily, and Expansion Cohort 3 (6 patients) will receive PCUR-101 at one dose level lower than the MTD in patients about to start abiraterone (1000 mg QD) and prednisone (5 mg twice daily [BID]) as their standard of care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

Part 1 dose escalation followed by a dose expansion

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PCUR-101 Dose Escalation

Arm Type

Experimental

Arm Description

PCUR-101 dosed orally once per day in 28 day cycles. Patients will be enrolled into escalating dose levels during the dose escalation phase

Arm Title

PCUR-101 Dose Expansion Cohort 1

Arm Type

Experimental

Arm Description

PCUR-101 dosed orally once per day in 28 day cycles

Arm Title

PCUR-101 Dose Expansion Cohort 2

Arm Type

Experimental

Arm Description

PCUR-101 in combination with dutasteride dosed orally once per day in 28 day cycles

Arm Title

PCUR-101 Dose Expansion Cohort 3

Arm Type

Experimental

Arm Description

PCUR-101 dosed orally once per day in combination with abiraterone (once per day) and prednisone (twice per day) in 28 day cycles

Intervention Type

Drug

Intervention Name(s)

PCUR-101

Intervention Description

50 mg capsules

Intervention Type

Drug

Intervention Name(s)

Dutasteride 0.5 mg

Intervention Description

0.5 mg capsules

Intervention Type

Drug

Intervention Name(s)

Abiraterone and Prednisone

Intervention Description

500 mg tablets Abiraterone with 5 mg Prednisone Tablets

Primary Outcome Measure Information:

Title

Occurrence of Dose Limiting Toxicity

Description

Incidence of Adverse Adverse Events

Time Frame

over the first 28 days of dosing

Secondary Outcome Measure Information:

Title

Determination of pharmacokinetic parameters - Tmax

Description

time to peak concentrations of PCUR-101

Time Frame

over the first 28 days of dosing

Title

Determination of pharmacokinetic parameters - Cmax

Description

peak concentrations of PCUR-101

Time Frame

over the first 28 days of dosing

Title

Determination of pharmacokinetic parameters - T1/2

Description

time from maximum concentration PCUR-101 to a reduction of plasma concentration by 50%

Time Frame

over the first 28 days of dosing

Title

Preliminary Evidence of efficacy/anti tumor activity - PSA levels

Description

as assessed by PSA changes

Time Frame

through study completion, average of 12 months

Title

Preliminary Evidence of efficacy/anti tumor activity - RECIST

Description

as assessed by RECIST 1.1 criteria

Time Frame

through study completion, average of 12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed diagnosis of prostate cancer Demonstrates metastatic CRPC Castrate level of serum testosterone at screening Adequate hematologic, renal, and hepatic function ECOG status ≤1 Life expectancy of at least 3 months No more than one prior course of cytotoxic chemotherapy Exclusion Criteria: Pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology Visceral metastasis excluding lymph nodes Use of opiate analgesics for prostate cancer pain or non-cancer pain other investigational agents or concurrent anticancer therapy other than standard androgen deprivation therapy within 4 weeks History of bleeding disorder History of seizure disorder Concomitant use of warfarin Prior exposure to PCUR-101 History of myocardial infarction, arterial thrombotic events, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia Received wide-field external beam radiation therapy within 4 weeks Moderate to severe neuropathy

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cancer Center Hotline

Phone

800-865-1125

First Name & Middle Initial & Last Name & Degree

Ulka Vaishampayan, MD

Facility Name

Nebraska Cancer Specialist

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Scott Degenhardt

Phone

402-334-4773

sdegenhardt@nebraskacancer.com

First Name & Middle Initial & Last Name & Degree

Ralph J Hauke, MD

Facility Name

St. George Private Hospital

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Individual Site Status

Completed

Facility Name

Sydney South West Private Hospital

City

Liverpool

State/Province

New South Wales

ZIP/Postal Code

2170

Country

Australia

Individual Site Status

Withdrawn

Facility Name

Southern Oncology Clinical Research

City

Bedford Park

State/Province

South Australia

ZIP/Postal Code

5042

Country

Australia

Individual Site Status

Completed

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of PCUR-101 in Combination With ADT in Patients With mCRPC

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