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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01681433
Recruitment Status : Terminated (lack of accrual)
First Posted : September 10, 2012
Results First Posted : October 18, 2018
Last Update Posted : July 11, 2022
Hoosier Cancer Research Network
Achieve Life Sciences
Information provided by (Responsible Party):
Costantine Albany, Hoosier Cancer Research Network

Brief 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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Actual Study Start Date : December 2012
Actual Primary Completion Date : June 21, 2017
Actual Study Completion Date : June 21, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 60 days ]
    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 :
  1. PSA Response [ Time Frame: 60 days ]
    Compare arms to determine the proportion of patients who have a PSA response (≥ 30% decline) and any PSA decline post-randomization.

Other Outcome Measures:
  1. Objective Response [ Time Frame: 60 days ]
    Compare arms to determine the objective response of study patients, per RECIST 1.1

  2. Time to Disease Progression [ Time Frame: 60 days ]
    Compare arms to determine the time to disease progression of study patients

  3. Circulating Tumor Cell (CTC) Counts [ Time Frame: Every 4 weeks ]
    Compare arms to determine circulating tumor cell (CTC) counts for patients at baseline and while on study

  4. Protein Levels [ Time Frame: Every 4 weeks ]
    Compare arms to determine levels of heat shock protein 27 (Hsp27), clusterin, and other relevant proteins of patients at baseline and during study

  5. Phosphatase and Tensin Homolog (PTEN) Deletion Status [ Time Frame: Every 4 weeks ]
    Compare arms to determine PTEN deletion status in original pathology specimens correlated with clinical outcomes

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01681433

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United States, California
Prostate Oncology Specialists, Inc.
Marina Del Rey, California, United States, 90292
United States, Indiana
IU Health Bloomington Hospital
Bloomington, Indiana, United States, 47403
IU Health Goshen Hospital
Goshen, Indiana, United States, 46527
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
IU Health Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Mexico
University of New Mexico Cancer Center: Albuquerque
Albuquerque, New Mexico, United States, 87131
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Canada, Alberta
Alberta Health Services: Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Canada, Quebec
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Costantine Albany
Hoosier Cancer Research Network
Achieve Life Sciences
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Principal Investigator: Constantine Albany, M.D. Hoosier Cancer Research Network
  Study Documents (Full-Text)

Documents provided by Costantine Albany, Hoosier Cancer Research Network:
Additional Information:
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)

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Responsible Party: Costantine Albany, Sponsor-Investigator, Hoosier Cancer Research Network Identifier: NCT01681433    
Other Study ID Numbers: GU12-159
First Posted: September 10, 2012    Key Record Dates
Results First Posted: October 18, 2018
Last Update Posted: July 11, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Costantine Albany, Hoosier Cancer Research Network:
Abiraterone Acetate
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Abiraterone Acetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors