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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Hoosier Cancer Research Network
Sponsor:
Collaborator:
OncoGenex Technologies
Information provided by (Responsible Party):
Hoosier Cancer Research Network
ClinicalTrials.gov Identifier:
NCT01681433
First received: September 5, 2012
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Metastatic Castrate-Resistant Prostate Cancer
PSA
Drug: OGX-427
Drug: Abiraterone Acetate
Drug: Prednisone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Pacific Clinical Trial: A Randomized Phase II Study Evaluating OGX-427 in Patients With Metastatic Castrate-Resistant Prostate Cancer (MCRPC)Who Have Prostate-Specific Antigen (PSA) Progression While Receiving Abiraterone: Hoosier Oncology Group GU12-159

Resource links provided by NLM:


Further study details as provided by Hoosier Cancer Research Network:

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    To ascertain whether Arm A has a greater proportion of patients observed to be alive without progression at Day 60 (±7 days) as compared to Arm B.


Secondary Outcome Measures:
  • PSA Response [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Compare arms to determine the proportion of patients who have a PSA response (≥ 30% decline) and any PSA decline post-randomization


Other Outcome Measures:
  • Objective Response [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Compare arms to determine the objective response of study patients.

  • Progression-Free Survival [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Compare arms to determine the rates of progression-free survival for study patients

  • Time to disease progression [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Compare arms to determine the time to disease progression of study patients

  • Circulating Tumor Cell (CTC) Counts [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
    Compare arms to determine circulating tumor cell (CTC) counts for patients at baseline and while on study

  • Protein Levels [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
    Compare arms to determine levels of heat shock protein 27 (Hsp27), clusterin, and other relevant proteins of patients at baseline and during study

  • Phosphatase and tensin homolog (PTEN) Deletion Status [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
    Compare arms to determine PTEN deletion status in original pathology specimens correlated with clinical outcomes


Estimated Enrollment: 74
Study Start Date: December 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental: Arm A
OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone
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
Active Comparator: Control Arm: Arm B
Continuation of standard therapy with abiraterone acetate and prednisone
Drug: Abiraterone Acetate
Standard therapy: Abiraterone Acetate 1000 mg PO daily
Drug: Prednisone
Standard therapy: Prednisone 10-20 mg PO daily

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet ALL of the following criteria to be eligible for inclusion into the study.

  • Histological or cytological diagnosis of adenocarcinoma of the prostate
  • Metastatic disease on chest, abdominal, or pelvic computed tomography (CT) scan and/or bone scan
  • Currently receiving abiraterone acetate and prednisone and meeting the following criteria:

    • Any PSA decline within 12 weeks from initiation of abiraterone acetate
    • Currently tolerating abiraterone acetate (1000 mg oral daily) and prednisone (10-20 mg oral daily)
    • PSA progression, defined as an increase in PSA which is ≥25% above the nadir and an absolute value of ≥2 ng/mL, which is confirmed by a second value ≥2 weeks later.
    • No evidence of symptomatic or radiographic progression that would require alternative therapy (e.g., needing radiation therapy for pain or significant progression of visceral metastases or >33% increase in daily opioid use within 2 weeks prior to randomization).
  • All patients who have not had a surgical orchiectomy must continue treatment with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist to maintain a castrate level of testosterone.
  • Patient must fulfill "Prior Therapy" criteria as follows:

    • Chemotherapy: no more than 1 prior chemotherapy regimen for castrate-resistant prostate cancer (CRPC) is permitted; a minimum of at least 28 days must have passed since the last dose of chemotherapy.
    • Hormone therapy: hormonal androgen ablation therapy prior to abiraterone is required.
    • Experimental therapy: prior non-cytotoxic experimental therapy is permitted provided a minimum of at least 14 days has passed since completing therapy. Prior treatment with enzalutamide (MDV3100) is allowed.
    • Radiation: prior external beam radiation is permitted provided a minimum of at least 14 days have passed since completing radiotherapy (exception for radiotherapy: at least 7 days since completing a single fraction of ≤800 cGy to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of randomization
  • Must be willing to use effective contraception throughout study treatment and for 3 months after completion of study treatment if able to father a child.
  • Must be willing not to change (add or subtract) bone protecting therapy (bisphosphonates and/or denosumab) during the study unless changed for toxicity.
  • Written informed consent must be obtained prior to any protocol-specific procedures being performed.

Exclusion Criteria:

Subjects meeting ANY of the following exclusion criteria will NOT be eligible for inclusion into the study:

  • Currently receiving abiraterone acetate in combination with any other anti-cancer agent (except prednisone)
  • Documented brain metastases, or carcinomatous meningitis, treated or untreated (Brain imaging for asymptomatic patients is not required.)
  • Cord compression requiring surgery or radiation therapy while on abiraterone treatment
  • Active second malignancy (including lymphoid malignancies such as chronic lymphocytic leukemia or low grade lymphoma) defined, in general, as requiring anticancer therapy or at high risk of recurrence during the study; not including adequately treated non melanomatous skin cancer or other solid tumors curatively treated with no evidence of disease in > 3 years
  • History of allergic reactions to therapeutic antisense oligonucleotides
  • Active autoimmune disease requiring treatment
  • Participated in a prior Phase 3 clinical study evaluating custirsen regardless of study arm assignment (i.e., either control or investigational arm), or prior exposure to OGX-427
  • Uncontrolled medical conditions such as myocardial infarction, uncontrolled hypertension, stroke or treatment of a major active infection within 3 months of randomization, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy
  • Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. Concomitant participation in observational studies is acceptable.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681433

Contacts
Contact: Christopher Sweeney, M.B., B.S. 617-632-4524 christopher_sweeney@dfci.harvard.edu
Contact: Cynthia Burkhardt, R.N. 317-921-2050 cburkhardt@hoosiercancer.org

Locations
United States, California
Prostate Oncology Specialists, Inc. Recruiting
Marina del Rey, California, United States, 90292
Contact: Mark Scholz, M.D.       mail@prostateoncology.com   
Contact: Ken Chau    310.827.7707 ext 32    Ken@prostateoncology.com   
United States, Indiana
IU Health Bloomington Hospital Withdrawn
Bloomington, Indiana, United States, 47403
IU Health Goshen Hospital Recruiting
Goshen, Indiana, United States, 46527
Contact: Alex Starodub, M.D.    574-535-2886    astarodub@iuhealth.org   
Contact: Rebecca Eickhoff, R.N.    574.364.2649      
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Costantine Albany, M.D.    317-278-1711    calbany@iu.edu   
Contact: Kerry Bridges    317-274-2552    kdbridge@iupui.edu   
IU Health Central Indiana Cancer Centers Recruiting
Indianapolis, Indiana, United States, 46219
Contact: Madelaine Sgroi, M.D.    317-859-5500    msgroi1@iuhealth.org   
Northern Indiana Cancer Research Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact: David Taber, M.D.    574-234-5123      
Contact: Alicia Dombkowski    574-647-7390    adombkowski@beaconhealthsystem.org   
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Christopher Sweeney, M.B., B.S.    617-632-4524    christopher_sweeney@dfci.harvard.edu   
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Brian Costello, M.D.    507-538-7623      
United States, New Mexico
University of New Mexico Cancer Center: Albuquerque Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Richard Laurer, M.D.       rlaurer@salud.unm.edu   
Contact: Kathy Anderson    505-925-0405      
United States, Virginia
Virginia Oncology Associates Recruiting
Norfolk, Virginia, United States, 23502
Contact: Mark Fleming, M.D.    757-213-5813    mark.fleming@usoncology.com   
Contact: Wendi Gobhart    757.213.5813    wendi.gobhart@usoncology.com   
Canada, Alberta
Alberta Health Services: Cancer Care Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Dean Ruether, M.D.    403.521.3093      
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Scott North, M.D.    780.432.8762    scottnor@cancerboard.ab.ca   
Contact: Daphne Willan    780.432.8788    daphnewi@cancerboard.ab.ca   
Canada, British Columbia
BC Cancer Agency Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Kim Chi, M.D.    604.877.6000 ext 2737    kchi@bccancer.bc.ca   
Contact: Shane Brown    604.877.6000 ext 2370    sbrown9@bccancer.bc.ca   
Canada, Manitoba
Cancer Care Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Joel Gingerich, M.D.       joel.gingerich@cancercare.mb.ca   
Contact: Heather Davies       heather.davies@cancercare.mb.ca   
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Sebastian Hotte, M.D.    905.387.9711 ext 64605      
Contact: Diane Derosa         
Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Fred Saad, M.D.    514.890.8000 ext 27466    fred.saad.chum@ssss.gouv.qc.ca   
Contact: Sylvie Dagenais    514.890.8000 ext 27466    sylvie.dagenais.chum@ssss.gouv.qc.ca   
Sponsors and Collaborators
Hoosier Cancer Research Network
OncoGenex Technologies
Investigators
Principal Investigator: Christopher Sweeney, M.B., B.S. Hoosier Cancer Research Network
  More Information

Additional Information:
Publications:
Kim N. Chi, Christopher Sweeney, Cindy Jacobs, Patricia S. Stewart, Noah M. Hahn. The Pacific trial: A randomized phase II study of OGX-427 in men with metastatic castration-resistant prostate cancer (mCRPC) and PSA progression while receiving abiraterone acetate (AA). J Clin Oncol 31, 2013 (suppl; abstr TPS5101) http://abstracts2.asco.org/AbstView_132_115104.html

Responsible Party: Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT01681433     History of Changes
Other Study ID Numbers: GU12-159
Study First Received: September 5, 2012
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Hoosier Cancer Research Network:
OGX-427
Abiraterone Acetate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014