NCT00447226终止2 期
A Phase II, Placebo Controlled, Double-Blind, Randomized, Discontinuation Study of Lapatinib Administered Orally to Subjects With ErbB2 Positive Ovarian, Gastric/Esophageal Adenocarcinoma, Uterine Serous Papillary, or Bladder Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants With the Indicated Tumor Response at 12 Weeks From First Dose
研究概览
简要总结
This study will examine the efficacy and safety of lapatinib in patients with ErbB2 positive ovarian, gastric/esophageal adenocarcinoma, uterine serous papillary, or bladder cancers.
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
- Double (Participant, Investigator)
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
- •Signed written informed consent.
- •Age >= 18 years old.
- •Life expectancy of at least 12 weeks.
- •Have histologically confirmed ovarian, gastric/esophageal adenocarcinoma, uterine serous papillary, or bladder cancer.
- •Have ErbB2-positive cancer as determined by Fluorescence In Situ Hybridization (FISH) assay.
- •Have documented tumor progression after receiving all standard/approved chemotherapies per National Comprehensive Cancer Network (NCCN) guidelines (V1) for their specific cancer and no approved therapy exists.
- •Have one or more tumors measurable by medical imaging and assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Have archived tumor tissue available for biomarker analysis.
- •Have a negative serum pregnancy test if female of childbearing potential.
- •Any chemotherapy, major surgery, or irradiation must have been completed at least 3 weeks prior to receiving study drug (6 weeks for mitomycin-C or nitrosourea) and subject must have recovered from all toxicities incurred as a result of previous therapy.
- •Have a gastrointestinal tract intact enough to swallow and assure absorption of the drug.
- •Women of childbearing potential must have a negative serum pregnancy test at screening and must use an approved contraceptive method, if appropriate (for example, intrauterine device, birth control pills, or barrier device) beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product. Males able to father a child must practice adequate methods of birth control or practice complete abstinence from intercourse from the first dose of investigational treatment until one week after the final dose of investigational treatment.
- •Have a cardiac ejection fraction within institutional range of normal as measured by either echocardiogram or multigated acquisition scans. The same method of cardiac evaluation must be used consistently throughout the study.
- •Subjects must have adequate organ function:
- •Hematologic:
- •absolute neutrophil count >1.5 x 109/L hemoglobin >9 g/dL platelets >75 x 109/L
- •albumin >2.5 g/dL serum bilirubin <1.25 x upper limit of normal aspartate aminotransferase/alanine aminotransferase <3 x ULN if no documented liver metastases aspartate aminotransferase/alanine aminotransferase <5 x ULN with documented liver metastases
- •serum creatinine <2.0 mg/dL
- •OR - calculated creatinine clearance1 >40 mL/min
排除标准
- •Have New York Heart Association Class III or IV, cardiac disease, myocardial infarction within past 6 months, unstable arrhythmia or evidence of ischemia on electrocardiogram.
- •Subjects who have had chemotherapy or radiotherapy within 3 weeks prior to entering the study or who have unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment.
- •Concurrent treatment with an investigational agent or participation in another treatment clinical trial.
- •Prior lapatinib therapy.
- •ECOG Performance Status 2 or greater.
- •Subjects receiving concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy (including an ErbB1 and/or ErbB2 inhibitor), or hormonal therapy for treatment of their cancer. Concurrent treatment with bisphosphonates is allowed.
- •History of allergic reactions attributed to compounds of similar chemical composition (quinazolines) to lapatinib.
- •Concurrent treatment with prohibited medications.
- •Malabsorption syndrome, resection of the small bowel or active, uncontrolled ulcerative colitis.
- •Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety.
- •Uncontrolled infection.
- •Pregnant or lactating females.
研究组 & 干预措施
Lapatinib Oral Tablets
Experimental
干预措施: Oral lapatinib tablets or placebo tablets (Drug)
Placebo Control
Placebo Comparator
干预措施: Oral lapatinib tablets or placebo tablets (Drug)
结局指标
主要结局
Number of Participants With the Indicated Tumor Response at 12 Weeks From First Dose
时间窗: Week 12
Per Response Evaluation Criteria In Solid Tumors (RECIST): Complete response (CR), disappearance of all lesions; partial response (PR), \>=30% decrease in the measurements of the largest lesions; stable disease (SD), insufficient shrinkage to qualify for PR or insufficient increase to qualify for progressive disease (PD); PD, \>=20% increase in measurements of lesions or appearance of new lesions. Data were not fully analyzed due to early study termination.
Percentage of Participants Who Remained Progression-free 12 Weeks After Randomization
时间窗: Week 12 after randomization.
The percentage of participants who did not show signs of progressive disease 12 weeks after receiving lapatinib or placebo in Stage 2 of the study (participants who maintained SD in Stage 1 were randomized to either lapatinib or placebo) was measured. Formal statistics for treatment comparison were not performed, due to early study termination. The percentage of participants displayed below includes those with CR + PR + SD.
次要结局
- Progression-free Survival (PFS)(From start of treatment to disease progression/death (assessments every 12 weeks until death for withdrawn participants and every 3 weeks for participants continuing on lapatinib))
- Number of Participants With the Indicated Change in Cancer Antigen-125 (CA-125) Levels From Day 1(Pre-dose and every 6 weeks until withdrawal (up to 84.1 weeks))
- Incidence of MET Amplification in Gastric Cancer(Performed on archived tissue collected at screening.)
- Duration of Response((assessments every 12 weeks until death for withdrawn participants and every 3 weeks for participants continuing on lapatinib))
- Time to Disease Progression (TTP)(From start of treatment to disease progression/death (up to 83.3 weeks))
- Incidence of ErbB2-positive Participants(Screening)
研究者
研究点 (1)
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