A Single Arm, Open-label, Phase II, Multicentre Study, to Assess the Safety of Vismodegib (GDC-0449) in Patient With Locally Advanced or Metastatic Basal Cell Carcinoma (BCC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,232
- 试验地点
- 181
- 主要终点
- Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons
研究概览
简要总结
This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >/=18 years of age
- •Metastatic or locally advanced basal cell carcinoma considered inoperable or that surgery is contraindicated and radiotherapy is contraindicated or inappropriate
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
排除标准
- •Concurrent anti-tumor therapy
- •Completion of the most recent anti-tumor therapy less than 21 days prior to the initiation of treatment
- •Uncontrolled medical illness
研究组 & 干预措施
Vismodegib - Locally Advanced
Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. vismodegib: 150 mg once daily until disease progression or unacceptable toxicity
干预措施: vismodegib (Drug)
Vismodegib - Metastatic
Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. vismodegib: 150 mg once daily until disease progression or unacceptable toxicity
干预措施: vismodegib (Drug)
结局指标
主要结局
Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons
时间窗: Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Reasons for "other" included "unknown," "natural causes," "cardiac decompensation," "general state alteration," "deterioration of general state," "clinical deterioration taking into consideration patient's age," "old age," and "disease progression of mediastinal squamous cell carcinoma (SCC)."
Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters
时间窗: Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Exposure to Study Treatment - Dose Intensity
时间窗: Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Dose intensity was defined as the percentage of actual number of doses received versus planned.
Exposure to Study Treatment: Duration on Treatment
时间窗: Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Duration on treatment was the number of days between first and last dose of study treatment.
Percentage of Participants Who Experienced Any Adverse Events (AEs), AEs Grade 3 or 4, AEs Leading to Drug Interruptions or Discontinuations and Any Serious Adverse Events (SAEs)
时间窗: Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival.
次要结局
- Progression-Free Survival (PFS)(Baseline to the data cut-off of 14 June 2017 (up to 6 years))
- Overall Survival (OS)(Baseline to the data cut-off of 14 June 2017 (up to 6 years))
- Duration of Response(Baseline to the data cut-off of 14 June 2017 (up to 6 years))
- Change From Baseline Scores of Skindex-16 Questionnaire Domains of Emotion, Function and Symptom(Baseline to the data cut-off date of 14 June 2017 (up to 6 years).)
- Best Overall Response Rate (BORR)(Baseline to the data cut-off of 14 June 2017 (up to 6 years))
- Time to Response(Baseline to the data cut-off of 14 June 2017 (up to 6 years))
- Percentage of Participants With a ≥ 30% Reduction in Disease-Related Symptoms According to MDASI Scale(08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).)
- Percentage of Participants With a ≥ 30% Reduction in Composite Symptom Severity Score According to MDASI Scale(08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).)