A Phase 2 Study of AbiVERtinib in Combination With Abiraterone in Patients With Metastatic Castration Resistant Prostate Cancer (Maverick Trial)
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 6-month radiographic progression-free survival
研究概览
简要总结
This is a phase 2, multicenter, open-label study to evaluate the efficacy of abivertinib with abiraterone in patients with metastatic castration-resistant prostate cancer.
详细描述
This is a phase 2, multicenter, open-label study to evaluate the efficacy of abivertinib with abiraterone in patients with metastatic castration-resistant prostate cancer via assessment of 6-month radiographic progression-free survival. The study will include two cohorts, abiraterone-naive and abiraterone-progressing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years of age
- •Metastatic disease as identified by imaging
- •Progressive mCRPC as defined by: 1) castrate levels of serum testosterone < 50 ng/dL and 2) progressive disease
- •Continued primary androgen deprivation with LHRH analogue (agonist or antagonist) if subject has not undergone bilateral orchiectomy
- •Germline testing for HSD3B
- •Confirmation of positivity for the adrenal-permissive HSD3B1(1245C) allele (germline heterozygous or homozygous) will be done centrally
- •For abiraterone-progressing cohort, abiraterone must be the most immediate preceding line of therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Adequate organ and marrow function
排除标准
- •Significant small cell or neuroendocrine component or histology
- •Prior enzalutamide, apalutamide, or darolutamide exposure for either hormone sensitive or CRPC. Prior abiraterone is prohibited for the abiraterone-naïve combination cohort
- •Prior BTK inhibitor treatment
- •Need for concurrent CYP3A inducers and inhibitors
- •Any condition including the presence of laboratory abnormalities that places the patient at unacceptable risk if the patient was to participate in the study
- •Corrected QT interval calculated by the Fridericia formula per electrocardiogram within 14 days before Cycle 1 Day 1
- •Any uncontrolled active systemic infection including any infection requiring systemic IV treatment that was completed ≤ 7 days before Cycle 1 Day 1, including active infection with COVID-19, defined as 10 days from the end of COVID-19 symptoms
- •Have human immunodeficiency virus (HIV) infection, human T-cell leukemia virus type 1 (HTLV1) infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or are at risk for HBV reactivation (at risk for HBV reactivation is defined as being HBs antigen positive, or anti-HBc-antibody positive), or are positive for HBV deoxyribonucleic acid (DNA). HCV ribonucleic acid (RNA) must be undetectable by laboratory test
- •Imminent or established spinal cord compression based on clinical and/or imaging findings
- •Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks prior to Cycle 1 Day 1
- •Major surgery within 4 weeks before Cycle 1 Day
- •Minor surgeries within 10 days before Cycle 1 Day
- •Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible
- •Radiation therapy within 2 weeks before Cycle 1 Day
- •Participation in another investigational trial and received treatment within 4 weeks before Cycle 1 Day 1
- •Any other active malignancy at the time of first dose of study treatment or diagnosis of another malignancy within 2 years prior to Cycle 1 Day 1 that requires active treatment, except locally curable cancers
- •Unable to swallow tablets/capsules whole
研究组 & 干预措施
Abivertinib - Abiraterone-progressing
Abiraterone-progressing: Abivertinib 200 mg by mouth twice daily with abiraterone 1000 mg by mouth daily.
干预措施: Abivertinib (Drug)
Abivertinib - Abiraterone-naive
Abiraterone-naive: Abivertinib 200 mg by mouth twice daily with abiraterone 1000 mg by mouth daily.
干预措施: Abivertinib (Drug)
Abivertinib - Abiraterone-naive
Abiraterone-naive: Abivertinib 200 mg by mouth twice daily with abiraterone 1000 mg by mouth daily.
干预措施: Abiraterone (Drug)
Abivertinib - Abiraterone-progressing
Abiraterone-progressing: Abivertinib 200 mg by mouth twice daily with abiraterone 1000 mg by mouth daily.
干预措施: Abiraterone (Drug)
结局指标
主要结局
6-month radiographic progression-free survival
时间窗: baseline through study completion at up to approximately 63 months
6-month radiographic progression-free survival (rPFS) will be assessed as defined by percent of subjects alive and without progression by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for measurable disease and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases.
次要结局
- Duration of response(baseline through study completion at up to approximately 63 months)
- Prostate-Specific Antigen (PSA) progression(baseline through study completion at up to approximately 63 months)
- Overall Response Rate(baseline through study completion at up to approximately 63 months)
- Time to first subsequent anti-cancer therapy(baseline through study completion at up to approximately 63 months)
- Safety and tolerability(baseline through study completion at up to approximately 63 months)
- Overall survival(baseline through study completion at up to approximately 63 months)
- Time to occurrence of first skeletal event(baseline through study completion at up to approximately 63 months)
- 6-month radiographic progression-free survival (rPFS)(baseline through study completion at up to approximately 63 months)