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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 72
- 试验地点
- 16
- 主要终点
- Progression-Free Survival
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental: Arm A
OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone
干预措施: OGX-427 (Drug)
Experimental: Arm A
OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone
干预措施: Abiraterone Acetate (Drug)
Experimental: Arm A
OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone
干预措施: Prednisone (Drug)
Control Arm: Arm B
Continuation of standard therapy with abiraterone acetate and prednisone
干预措施: Abiraterone Acetate (Drug)
Control Arm: Arm B
Continuation of standard therapy with abiraterone acetate and prednisone
干预措施: Prednisone (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: 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.
次要结局
- PSA Response(60 days)
研究者
Costantine Albany
Sponsor-Investigator
Hoosier Cancer Research Network