A Randomized Phase 2 Study of Cabozantinib (XL184) in Combination With Abiraterone in Chemotherapy Naïve Subjects With Bone-Metastatic Castration-Resistant Prostate Cancer (CRPC)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Exelixis
- 入组人数
- 54
- 试验地点
- 20
- 主要终点
- Radiographic Progression Free Survival (PFS)
研究概览
简要总结
This study was conducted in subjects in chemotherapy-naïve subjects with bone-metastatic castration-resistant prostate cancer (CRPC).
详细描述
The goal of this clinical trial was to learn if the combination of the drugs cabozantinib and abiraterone works for men that were chemotherapy-naive, bone metastasis CRPC patients. It was designed to learn about the safety of cabozantinib. The main questions are:
- Does it work and is it safe in men with chemotherapy-naïve bone- metastatic castration resistant CRPC?
- What was the clinical benefit at different dose levels of the combination of abiraterone and cabozantinib in this patient population?
Participants were assigned to one of the four treatment groups:
Arm 1. cabozantinib at a dose of 40 mg every day (QD) plus abiraterone with prednisone; Arm 2. cabozantinib at a dose of 20 mg QD plus abiraterone with prednisone; Arm 3. cabozantinib at a dose of 20 mg every other day (QOD) plus abiraterone with prednisone; Arm 4. abiraterone with prednisone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically or cytologically confirmed adenocarcinoma of the prostate.
- •Must be surgically or medically castrated (serum testosterone levels less than or equal to 50 ng/dL)
- •Must have castration-resistant prostate cancer (CRPC) with disease progression during LHRH therapy or after a surgical bilateral orchiectomy.
- •Bone metastasis related to prostate cancer
- •Adequate organ and marrow function
- •Capable of understanding and complying with the protocol requirements and signed the informed consent document
- •Sexually active subjects and their partners must agree to use medically accepted methods of barrier contraception (eg, male condom or female condom) as well as one other medically accepted method of contraception during the course of the study treatment and for 4 months after the last dose of study treatment.
排除标准
- •Any prior treatment with abiraterone, enzalutamide, or any investigational agents blocking androgen receptor (AR) or androgen synthesis.
- •Any prior treatment with cabozantinib or participation in a prior clinical trial of cabozantinib.
- •Any prior cytotoxic therapy (including estramustine) or biologic therapy for the treatment of prostate cancer (a few exceptions will be allowed)
- •Any prior radionuclide therapy (eg, samarium 153, strontium 89, alpharadin)
- •Use of investigational agent within 28 days
- •Any pathological finding consistent with small cell carcinoma of the prostate
- •Known brain metastases or cranial epidural disease
- •Diagnosis of another malignancy within 2 years, except for superficial non-melanoma skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy
研究组 & 干预措施
Arm 3: Cabozantinib 20 mg (every other day) + abiraterone and prednisone
Cabozantinib 20 mg every other day with abiraterone and prednisone
干预措施: cabozantinib (Drug)
Arm 1: Cabozantinib 40 mg + abiraterone with prednisone
Cabozantinib 40 mg, by mouth daily (po QD), + abiraterone with prednisone
干预措施: cabozantinib (Drug)
Arm 1: Cabozantinib 40 mg + abiraterone with prednisone
Cabozantinib 40 mg, by mouth daily (po QD), + abiraterone with prednisone
干预措施: abiraterone (Drug)
Arm 1: Cabozantinib 40 mg + abiraterone with prednisone
Cabozantinib 40 mg, by mouth daily (po QD), + abiraterone with prednisone
干预措施: prednisone (Drug)
Arm 2: Cabozantinib 20 mg + abiraterone and prednisone
Cabozantinib 20 mg, by mouth daily (po QD), + abiraterone with prednisone
干预措施: cabozantinib (Drug)
Arm 2: Cabozantinib 20 mg + abiraterone and prednisone
Cabozantinib 20 mg, by mouth daily (po QD), + abiraterone with prednisone
干预措施: abiraterone (Drug)
Arm 2: Cabozantinib 20 mg + abiraterone and prednisone
Cabozantinib 20 mg, by mouth daily (po QD), + abiraterone with prednisone
干预措施: prednisone (Drug)
Arm 3: Cabozantinib 20 mg (every other day) + abiraterone and prednisone
Cabozantinib 20 mg every other day with abiraterone and prednisone
干预措施: abiraterone (Drug)
Arm 3: Cabozantinib 20 mg (every other day) + abiraterone and prednisone
Cabozantinib 20 mg every other day with abiraterone and prednisone
干预措施: prednisone (Drug)
Arm 4: Abiraterone and prednisone only
Abiraterone with prednisone
干预措施: abiraterone (Drug)
Arm 4: Abiraterone and prednisone only
Abiraterone with prednisone
干预措施: prednisone (Drug)
结局指标
主要结局
Radiographic Progression Free Survival (PFS)
时间窗: Up to 18 Months
PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause, as assessed by Independent Radiology Committee (IRC). The sponsor terminated the study early due to business reasons. As such, no data were collected for efficacy analyses.
次要结局
未报告次要终点