A Prospective International Multicenter Phase II Study to Evaluate the Efficacy, Safety and Quality of Life of Pazopanib in Patients With Advanced and/or Metastatic Renal Cell Carcinoma After Previous Therapy With Checkpoint Inhibitor Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The main purpose of this study was to assess the progression-free survival (PFS) based on local investigator assessment of pazopanib in participants with advanced and/or metastatic renal cell carcinoma (mRCC) following prior treatment with immune checkpoint inhibitors (ICI).
详细描述
This was a multi-center, open-label, single-arm Phase II study to determine the efficacy, tolerability, safety and quality of life of treatment with pazopanib in subjects with advanced and/or metastatic renal cell carcinoma (RCC) following prior treatment with immune checkpoint inhibitors (ICI).
Subjects could have received prior systemic therapy with an ICI (monotherapy or combination) as 1st or 2nd line RCC treatment. However, they must not have received pazopanib previously. In this study, pazopanib could be administered in the 2nd or 3rd line setting. The therapeutic line for individual subjects was assigned at the time of screening.
Subjects received 800 mg of pazopanib daily until disease progression, unacceptable toxicity, death, pregnancy, start of a new anti-neoplastic therapy, discontinuation at the discretion of the investigator or patient, lost to follow-up or end of study, whichever came first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed locally recurrent or metastatic predominantly clear cell renal cell carcinoma.
- •Measurable disease based on RECIST 1.1 criteria
- •Prior systemic therapy with an immune checkpoint inhibitor (monotherapy or combination) as 1st or 2nd line RCC treatment. Note: patients with prior mTOR inhibitor or TKI treatment as monotherapy or in combination with immune checkpoint inhibitor were allowed; however, treatment with immune checkpoint inhibitor (monotherapy or in combination) must have been the last treatment prior to study entry.
- •Last dose of immune checkpoint inhibitor therapy received 4 or more weeks before start of study treatment
- •Karnofsky performance status ≥70%.
- •Potassium, sodium, calcium and magnesium within normal limits of the central laboratory
排除标准
- •Renal cell carcinoma without any clear (conventional) cell component
- •History or evidence of central nervous system (CNS) metastases (patients with pretreated metastases were eligible under certain conditions)
- •Prior treatment with pazopanib
- •Prior treatment with bevacizumab that was not given in combination with immune checkpoint inhibitor therapy.
- •Prior treatment with more than 2 lines of therapy (combination treatments were considered 1 line of therapy)
- •Not recovered from toxicity from prior immune checkpoint inhibitor therapy. Recovery was defined as ≤ NCI-CTCAE Grade 1, except for liver function test levels which must be <Grade
- •Disease recurrence less than 6 months from the last dose of prior neoadjuvant or adjuvant therapy (including VEGF-R TKI)
- •Patients receiving prohibited concomitant medications that could not be discontinued or replaced by safe alternative medication at least 5 half-lives of the concomitant medication or 7 days, whichever was longer, prior to the start of pazopanib treatment.
- •Administration of any investigational drug within 4 weeks prior to the first dose of study treatment
研究组 & 干预措施
Pazopanib- 2nd line treatment
Participants received pazopanib as 2nd line treatment
干预措施: Pazopanib (Drug)
Pazopanib- 3rd line treatment
Participants received pazopanib as 3rd line treatment
干预措施: Pazopanib (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Date of first treatment to date of progression or death up to approximately 38 months
PFS is defined as the time from the start date of pazopanib treatment to the date of the first documented progression or death due to any cause. PFS was assessed via local review according to RECIST 1.1. PFS was censored at the date of the last adequate tumor assessment if no PFS event (disease progression or death due to any cause) was observed prior to the analysis cut-off date. The PFS distribution was estimated using the Kaplan-Meier method.
次要结局
- Overall Survival (OS)(From date of first treatment to date of death, up to approximately 44 months)
- Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score(Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 9, 11, 13, 16 and every 3rd cycle thereafter until end of treatment, and end of treatment, assessed up to approximately 38 months. Cycle=28 days)
- Overall Response Rate (ORR) Based on Local Investigator Assessment According to RECIST v1.1(Up to approximately 38 months)
- Clinical Benefit Rate (CBR) Based on Local Investigator Assessment According to RECIST v1.1.(Up to approximately 38 months)
- Duration of Response (DOR) Based on Local Investigators Assessment According to RECIST v1.1(From the date of first documented response (confirmed CR or PR) to the date of tumor progression, up to approximately 36 months)
- Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score(Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 9, 11, 13, 16 and every 3rd cycle thereafter until end of treatment, and end of treatment, assessed up to approximately 38 months. Cycle=28 days)