Prostate Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

48

Study ID:

NCT04677855

Recruitment Status:

Recruiting

Sponsor:

Pellficure Pharmaceuticals, Inc

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There are 4 Locations for this study

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Nebraska Cancer Specialist
Omaha Nebraska, 68130, United States More Info
Scott Degenhardt
Contact
402-334-4773
[email protected]
Ralph J Hauke, MD
Principal Investigator
St. George Private Hospital
Kogarah New South Wales, 2217, Australia
Sydney South West Private Hospital
Liverpool New South Wales, 2170, Australia
Southern Oncology Clinical Research
Bedford Park South Australia, 5042, Australia

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

48

Study ID:

NCT04677855

Recruitment Status:

Recruiting

Sponsor:


Pellficure Pharmaceuticals, Inc

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