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

NCT04677855 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-04-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PCUR-101

50 mg capsules

DRUG

Dutasteride 0.5 mg

0.5 mg capsules

DRUG

Abiraterone and Prednisone

500 mg tablets Abiraterone with 5 mg Prednisone Tablets

Sponsors & Collaborators

  • Pellficure Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-30
Primary Completion
2023-10-23
Completion
2023-11-20
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04677855 on ClinicalTrials.gov