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OGX-427 in Metastatic Castrate-Resistant Prostate Cancer With Prostate-Specific Antigen Progression While Receiving Abiraterone

NCT01681433 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-07-11

Study results available
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Summary

This Phase II study has been designed to evaluate the anti-tumor effects of adding OGX-427 to continuing abiraterone acetate and prednisone treatment in men with metastatic castrate-resistant prostate cancer (MCRPC) who have prostate-specific antigen (PSA) progression

Conditions

Interventions

DRUG

OGX-427

OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV

DRUG

Abiraterone Acetate

Standard therapy: Abiraterone Acetate 1000 mg PO daily

DRUG

Prednisone

Standard therapy: Prednisone 10-20 mg PO daily

Sponsors & Collaborators

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Achieve Life Sciences

    collaborator INDUSTRY

  • Costantine Albany

    lead OTHER

Principal Investigators

  • Constantine Albany, M.D. · Hoosier Cancer Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2017-06-21
Completion
2017-06-21

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
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 NCT01681433 on ClinicalTrials.gov