NCT01310816已完成2 期
A Phase 2, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of IPI-926 in Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 36
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma.
详细描述
Study IPI-926-04 is a Phase 2, double-blind, placebo-controlled, multicenter, trial evaluating the safety and efficacy of IPI-926 in patients with metastatic or locally advanced (unresectable) chondrosarcoma. The study includes an optional cross-over to open-label IPI-926 for patients randomly assigned to placebo who experience documented disease progression.
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
- Triple (Participant, Care Provider, 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
- •At least 18 years of age at the time of signing informed consent.
- •Pathologically diagnosed conventional chondrosarcoma. Patients must have tumor sample(s) available or provide tumor samples from a new biopsy
- •Metastasis to at least 1 location or locally advanced disease that is deemed unresectable by a surgeon
- •At least 1 radiologically measurable target lesion per RECIST 1.
- •Patients must have documented radiographic progression of disease within the 6-month period prior to screening. (MRI or CT Scan)
- •Eastern Cooperative Oncology Group (ECOG) performance status: 0 or
- •Life expectancy of at least 3 months
- •All women of child-bearing potential (WCBP), all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study and for 30 days after the last dose of study drug.
- •Ability to adhere to the study visit schedule and all protocol requirements.
- •Voluntarily signed an informed consent form.
排除标准
- •Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localized cured prostate and cervical cancer.
- •Systemic anti-cancer therapy within 21 days prior to the first dose of study drug, or radiotherapy within 14 days prior to the first dose of study drug.
- •Prior treatment with a Hedgehog pathway inhibitor
- •Medically significant surgical procedures or significant traumatic injury within 28 days before Day
- •Inadequate hematologic function defined by:
- •Hemoglobin <8.0 g/dL (80 g/L) (may be increased to this level with transfusion as long as there is no evidence of active bleeding).
- •Inadequate hepatic function defined by:
- •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN).
- •Total bilirubin >1.5 x ULN (with the exception of patients with Gilbert's disease).
- •Cirrhotic liver disease, ongoing alcohol abuse, or known chronic active or acute hepatitis.
- •Inadequate renal function defined by serum creatinine >1.5 x ULN
- •Patients with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
- •Presence of active infection or systemic use of antibiotics within 72 hours of treatment.
- •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. Examples include, but are not limited to sepsis and recent significant traumatic injury.
- •Known human immunodeficiency virus (HIV) positivity.
- •Known hypersensitivity to IPI-926, or any of the excipients in IPI-926 or placebo capsules.
- •Pregnant or lactating women.
- •Current administration of the medications or foods which are known to be moderate or strong inhibitors of CYP3A4 activity
研究组 & 干预措施
IPI-926
Active Comparator
IPI-926
干预措施: IPI-926 (Drug)
Sugar Pill
Placebo Comparator
Placebo Arm, sugar pill
干预措施: Placebo Arm (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: estimated 6 months
* To compare progression-free survival (PFS) in patients with metastatic or locally advanced (unresectable) chondrosarcoma administered IPI-926 or placebo. * Number of Incidence of reported adverse events and abnormal laboratory test results. To evaluate the safety of IPI-926 or placebo in patients with metastatic or locally advanced (unresectable) chondrosarcoma
次要结局
- Comparison of Time To Progression (TTP)(estimated 6 months)
- Comparison of Overall Survival (OS)(estimated 6 months)
- Overall Response Rate (ORR)(estimated 6 months)
研究者
研究点 (36)
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