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
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 5-20 mg PO daily
CONTROL ARM (Arm B):
Continuation of standard therapy with abiraterone acetate 1000 mg PO daily and prednisone
5-20 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Patients who are withdrawn from the study for a reason other than documented disease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
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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
No
Christopher Sweeney, M.B., B.S.
Principal Investigator
Hoosier Oncology Group
United States: Food and Drug Administration
GU12-159
NCT01681433
December 2012
June 2015
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Virginia Oncology Associates | Newport News, Virginia 23606 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Prostate Oncology Specialists, Inc. | Marina Del Rey, California 90292 |
IU Health Central Indiana Cancer Centers | Indianapolis, Indiana 46219 |
University of New Mexico Cancer Care Alliance | Albuquerque, New Mexico 87131 |
IU Health Goshen Hospital | Goshen, Indiana 46527 |