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

NCT01681433 | Terminated Phase 2 Results DMC

• 1 other identifier: GU12-159
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 16

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

Conditions

Prostate Cancer; Metastatic Castrate-Resistant Prostate Cancer; PSA

Keywords

OGX-427; Abiraterone Acetate

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  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.

  60 days

Secondary Outcomes (1)

• PSA Response

  60 days

Other Outcomes (5)

• Objective Response

  60 days

• Time to Disease Progression

  60 days

• Circulating Tumor Cell (CTC) Counts

  Every 4 weeks

Study Arms (2)

Experimental: Arm A

EXPERIMENTAL

OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone

Drug: OGX-427; Drug: Abiraterone Acetate; Drug: Prednisone

Control Arm: Arm B

ACTIVE COMPARATOR

Continuation of standard therapy with abiraterone acetate and prednisone

Drug: Abiraterone Acetate; Drug: Prednisone

Interventions

OGX-427 DRUG

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

Experimental: Arm A

Abiraterone Acetate DRUG

Standard therapy: Abiraterone Acetate 1000 mg PO daily

Control Arm: Arm B; Experimental: Arm A

Prednisone DRUG

Standard therapy: Prednisone 10-20 mg PO daily

Control Arm: Arm B; Experimental: Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Costantine Albany: lead
• Hoosier Cancer Research Network: collaborator
• Achieve Life Sciences: collaborator

Study Sites (16)

Prostate Oncology Specialists, Inc.

Marina del Rey, California, 90292, United States

Location

IU Health Bloomington Hospital

Bloomington, Indiana, 47403, United States

Location

IU Health Goshen Hospital

Goshen, Indiana, 46527, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

IU Health Central Indiana Cancer Centers

Indianapolis, Indiana, 46219, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of New Mexico Cancer Center: Albuquerque

Albuquerque, New Mexico, 87131, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Alberta Health Services: Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (1)

• 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

  BACKGROUND

Related Links

• Hoosier Cancer Research Network Website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

apatorsen; Abiraterone Acetate; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes

Results Point of Contact

• Title: Clinical Data Coordinator
• Organization: Hoosier Cancer Research Network

jsmith@hoosiercancer.org

317-921-2050

Study Officials

• Constantine Albany, M.D.

  Hoosier Cancer Research Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 10, 2012
• Study Start: December 1, 2012
• Primary Completion: June 21, 2017
• Study Completion: June 21, 2017
• Last Updated: July 11, 2022
• Results First Posted: October 18, 2018

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (10); CA (6)