NCT00688766终止3 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Evaluating the Efficacy and Safety of IPI-504 in Patients With Metastatic and/or Unresectable GIST Following Failure of at Least Imatinib and Sunitinib
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 47
- 主要终点
- Compare the progression free survival (PFS) in both study arms
研究概览
简要总结
IPI-504-06 is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of IPI-504 as compared to placebo in patients with metastatic and/or unresectable GIST following failure of at least imatinib and sunitinib.
Approximately 195 patients will be randomized using a 2:1 ratio to receive either IPI-504 (N=130) or placebo (N=65). Upon unblinding, patients receiving either IPI-504 or placebo may receive IPI-504 in the open-label portion of the study if defined inclusion criteria are met.
Early and frequent imaging timepoints (Weeks 2, 5, 8, 14 and every 6 weeks thereafter) are incorporated into this study to capture progression events and limit patient exposure to ineffective agents.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •At least 18 years of age at the time of study randomization.
- •Histologically confirmed metastatic and/or unresectable GIST.
- •Measurable disease on CT or MRI as defined by RECIST.
- •Documented radiographic progression or intolerance to imatinib and sunitinib.
- •Clinical failure of the most recent prior therapy for GIST. Note: There is no limit to the number of prior therapies a patient may have received.
- •Eastern Cooperative Oncology Group (ECOG) performance status: 0 or
- •Hemoglobin ≥ 8.0 g/dL (80 g/L).
- •Absolute Neutrophil Count ≥ 1500/µL (1.5 x 109/L).
- •Platelets ≥ 100,000 /µL (100 x 109/L).
- •ALT and AST ≤ 2.5 x upper limit of normal (ULN), or ≤ 5.0 x ULN if considered secondary to liver metastases.
- •Alkaline phosphatase ≤ 2.5 x ULN, or ≤ 5.0 x ULN if considered secondary to liver metastases.
- •Serum bilirubin ≤ 1.5 x ULN.
- •PT and PTT ≤ 1.5 x ULN unless the patient is receiving warfarin. If the patient is receiving warfarin, the INR must be within therapeutic range.
- •Serum creatinine ≤ 1.5 x ULN.
排除标准
- •Previous administration of other known heat shock protein 90 (Hsp90) inhibitors.
- •Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease.
- •Initiation or discontinuation of concurrent medication that is a potent CYP3A inhibitor less than 2 weeks prior to administration of IPI-504 or placebo.
- •History of any of the following within the last 6 months: cardiac disease such as acute coronary syndrome or unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, cirrhotic liver disease, cerebrovascular accident, or any other significant co-morbid condition or disease which, in the judgment of the investigator, would place the patient at undue risk or interfere with the study.
- •Grade 3 or 4 hemorrhagic event within the last 6 months.
- •Known human immunodeficiency virus positivity.
- •Sinus bradycardia (resting heart rate < 50 bpm) secondary to intrinsic conduction system disease.
- •QTcF ≥ 470 milliseconds, or previous history of clinically significant QTc prolongation while taking other medications.
- •History of prior malignancies within the past 3 years other than non-melanomatous skin cancers that have been controlled, prostate cancer that has been treated and has not recurred, non-muscle-invasive bladder cancer, and carcinoma in situ of the cervix.
- •Active or recent history (within 3 months) of keratitis or keratoconjunctivitis confirmed by ophthalmology or optometry exam.
- •Presence of Left Bundle Branch Block, Right Bundle Branch Block plus left anterior hemiblock, bifascicular block, or 3rd degree heart block. This does not include patients with a history of these events with adequate control by pacemaker.
- •Known CNS metastases.
- •Women who are pregnant or lactating.
研究组 & 干预措施
IPI-504
Experimental
retaspimycin hydrochloride (IPI-504) plus best supportive care
干预措施: retaspimycin hydrochloride (IPI-504) (Drug)
IPI-504
Experimental
retaspimycin hydrochloride (IPI-504) plus best supportive care
干预措施: Best supportive care (Other)
Placebo
Placebo Comparator
Placebo plus best supportive care
干预措施: placebo (Drug)
Placebo
Placebo Comparator
Placebo plus best supportive care
干预措施: Best supportive care (Other)
结局指标
主要结局
Compare the progression free survival (PFS) in both study arms
时间窗: Multiple timepoints
次要结局
- Compare the disease control rate (DCR) in both arms(Multiple timepoints)
- Compare the time to progression (TTP) in both arms(Multiple timepoints)
- Compare the overall survival (OS) in both arms(Continuous)
- Evaluate the safety and tolerability of IPI-504 in this patient population(Signing of the informed consent to 30 days after discontinuation of drug)
研究者
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