Prostate CancerPhase 2NCT01681433
OGX-427 in Metastatic Castrate-Resistant Prostate Cancer With Prostate-Specific Antigen Progression While Receiving Abiraterone
A Phase 2 study testing OGX-427, Abiraterone Acetate and Prednisone in people with Prostate Cancer and Metastatic Castrate-Resistant Prostate Cancer, run by Costantine Albany at 16 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Metastatic Castrate-Resistant Prostate Cancer, PSA
- What is being tested?
- OGX-427, Abiraterone Acetate and Prednisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Dec 2012to 21 Jun 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States10 sites
University of New Mexico Cancer Center: Albuquerque
Albuquerque, New Mexico, 87131
IU Health Bloomington Hospital
Bloomington, Indiana, 47403
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
IU Health Goshen Hospital
Goshen, Indiana, 46527
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
IU Health Central Indiana Cancer Centers
Indianapolis, Indiana, 46219
Prostate Oncology Specialists, Inc.
Marina del Rey, California, 90292
Virginia Oncology Associates
Norfolk, Virginia, 23502
Mayo Clinic
Rochester, Minnesota, 55905
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
Canada6 sites
Alberta Health Services: Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2L 4M1
BC Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
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
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
Read the detailed description
OUTLINE: This is a multi-center study.
This is an open-label, randomized, Phase II clinical trial designed to evaluate the anti-tumor effects of OGX-427 and continuing abiraterone acetate and prednisone versus continuing abiraterone acetate and prednisone alone in men with MCRPC who have evidence of PSA progression but 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).
Patients on the control arm will be allowed to cross-over to receive OGX-427 following documented disease progression. Patients will be randomized with equal probability to one of the following arms:
EXPERIMENTAL ARM (Arm A):
OGX-427 Starting within 7 days of randomization, three loading doses of 600 mg intravenously (IV) within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV
Continuation of standard therapy with abiraterone acetate 1000 mg by mouth (PO) daily and prednisone 10-20 mg PO daily
CONTROL ARM (Arm B):
Continuation of standard therapy with abiraterone acetate 1000 mg PO daily and prednisone 10-20 mg PO daily
After documented disease progression, patients on Arm B may opt to receive OGX-427 treatment (according to the Arm A schedule) following a screening evaluation (i.e., all inclusion and exclusion criteria have been met)
Both Arms:
Evaluations at 4 week-intervals. Disease assessments required at the milestone Day 60 assessment (expected to occur after 8 weeks of treatment and prior to Day 1, Week 9) and at 16, 24, 32, 40, and 48 weeks (if applicable) or until documented disease progression. Patients who are withdrawn from the study for a reason other than documented disease progression or patient withdrawal of consent will be followed every 4 weeks in the Off-Treatment Follow-up Period until documented disease progression.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life Expectancy: Not Specified
Hematopoietic:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109 cells /L, platelet count ≥ 100 x 109 /L, and hemoglobin ≥ 9 g/dL without transfusion
Hepatic:
- Total bilirubin ≤ 1.1 x upper limit of normal (ULN) unless elevated secondary to conditions such as Gilbert's disease, in which case a direct bilirubin ≤ ULN is required
- Serum glutamic pyruvic transaminase (SGPT), alanine transaminase (ALT) and alanine transaminase (SGOT) aspartate transaminase (AST) ≤ 3.0 x ULN
Renal:
- Creatinine ≤ 1.3 x ULN
Cardiac:
- Known left ventricular ejection fraction (LVEF) <50% or New York Heart Association (NYHA) Functional Classification Class III or IV heart failure
Other:
- Castrate serum testosterone level (< 50 ng/dL or < 1.7 nmol/L)
- Potassium within normal limits
- Being tested
- OGX-427, Abiraterone Acetate, Prednisone
- Keywords
- OGX-427, Abiraterone Acetate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OGX-427Drug
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
Abiraterone AcetateDrug
Standard therapy: Abiraterone Acetate 1000 mg PO daily
PrednisoneDrug
Standard therapy: Prednisone 10-20 mg PO daily
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Arm A | Experimental | OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone Receives: Drug: OGX-427; Drug: Abiraterone Acetate; Drug: Prednisone |
| Control Arm: Arm B | Active comparator | Continuation of standard therapy with abiraterone acetate and prednisone Receives: Drug: Abiraterone Acetate; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days
Secondary outcomes (1)
PSA Response
Compare arms to determine the proportion of patients who have a PSA response (≥ 30% decline) and any PSA decline post-randomization.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startDec 2012
- Primary completion21 Jun 2017
- Study completion21 Jun 2017
Why it stopped: lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Costantine Albany
- Sponsor type
- University, hospital or other
- Collaborators
- Hoosier Cancer Research Network, Achieve Life Sciences
- Responsible party
- Sponsor-investigator, Costantine Albany, Hoosier Cancer Research Network
- Investigators
- Constantine Albany, M.D., Principal investigator, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681433
- Sponsor's protocol ID
- GU12-159
- Status last verified
- Jul 2022
- First submitted
- 5 Sep 2012
- Last updated
- 11 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01681433
- Acronym / sponsor ID
- GU12-159
- Keywords
- OGX-427, Abiraterone Acetate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of accrual
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Costantine AlbanyUniversity, hospital or other
- Collaborators
- Hoosier Cancer Research Network, Achieve Life Sciences
- Study start
- Dec 2012 (actual)
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 10 Sep 2012 (estimated)
- Results
- Posted 18 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
OUTLINE: This is a multi-center study.
This is an open-label, randomized, Phase II clinical trial designed to evaluate the anti-tumor effects of OGX-427 and continuing abiraterone acetate and prednisone versus continuing abiraterone acetate and prednisone alone in men with MCRPC who have evidence of PSA progression but 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).
Patients on the control arm will be allowed to cross-over to receive OGX-427 following documented disease progression. Patients will be randomized with equal probability to one of the following arms:
EXPERIMENTAL ARM (Arm A):
OGX-427 Starting within 7 days of randomization, three loading doses of 600 mg intravenously (IV) within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV
Continuation of standard therapy with abiraterone acetate 1000 mg by mouth (PO) daily and prednisone 10-20 mg PO daily
CONTROL ARM (Arm B):
Continuation of standard therapy with abiraterone acetate 1000 mg PO daily and prednisone 10-20 mg PO daily
After documented disease progression, patients on Arm B may opt to receive OGX-427 treatment (according to the Arm A schedule) following a screening evaluation (i.e., all inclusion and exclusion criteria have been met)
Both Arms:
Evaluations at 4 week-intervals. Disease assessments required at the milestone Day 60 assessment (expected to occur after 8 weeks of treatment and prior to Day 1, Week 9) and at 16, 24, 32, 40, and 48 weeks (if applicable) or until documented disease progression. Patients who are withdrawn from the study for a reason other than documented disease progression or patient withdrawal of consent will be followed every 4 weeks in the Off-Treatment Follow-up Period until documented disease progression.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life Expectancy: Not Specified
Hematopoietic:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109 cells /L, platelet count ≥ 100 x 109 /L, and hemoglobin ≥ 9 g/dL without transfusion
Hepatic:
- Total bilirubin ≤ 1.1 x upper limit of normal (ULN) unless elevated secondary to conditions such as Gilbert's disease, in which case a direct bilirubin ≤ ULN is required
- Serum glutamic pyruvic transaminase (SGPT), alanine transaminase (ALT) and alanine transaminase (SGOT) aspartate transaminase (AST) ≤ 3.0 x ULN
Renal:
- Creatinine ≤ 1.3 x ULN
Cardiac:
- Known left ventricular ejection fraction (LVEF) <50% or New York Heart Association (NYHA) Functional Classification Class III or IV heart failure
Other:
- Castrate serum testosterone level (< 50 ng/dL or < 1.7 nmol/L)
- Potassium within normal limits
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Arm A | Experimental | Drug: OGX-427, Drug: Abiraterone Acetate, Drug: PrednisoneOGX-427 + continuation of standard therapy with abiraterone acetate and prednisone |
| Control Arm: Arm B | Active comparator | Drug: Abiraterone Acetate, Drug: PrednisoneContinuation of standard therapy with abiraterone acetate and prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OGX-427OGX-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 | Experimental: Arm A |
| Abiraterone AcetateStandard therapy: Abiraterone Acetate 1000 mg PO daily | Drug | Control Arm: Arm B, Experimental: Arm A |
| PrednisoneStandard therapy: Prednisone 10-20 mg PO daily | Drug | Control Arm: Arm B, Experimental: Arm A |
Primary outcome
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.
1 secondary outcome
PSA Response
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundKim 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
- Hoosier Cancer Research Network WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constantine Albany, M.D. principal investigator
Hoosier Cancer Research Network
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OGX-427, Abiraterone Acetate and Prednisone in people with Prostate Cancer and Metastatic Castrate-Resistant Prostate Cancer, run by Costantine Albany at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01681433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.