NCT00969917撤回2 期
A Phase 2, Open-Label Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To determine the safety profile and overall response rate (ORR) of IPI 504 in patients with advanced dedifferentiated liposarcoma.
研究概览
简要总结
The primary objective of the study is to determine the safety profile and overall response rate of IPI 504 in patients with advanced dedifferentiated liposarcoma.
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
- •At least 18 years of age at the time of signing informed consent.
- •Histologic diagnosis of dedifferentiated liposarcoma.
- •Available archival pathology specimen or tissue sample from a new biopsy for confirmation of diagnosis by central pathology reading.
- •At least one prior chemotherapy regimen for dedifferentiated liposarcoma.
- •No more than 2 prior chemotherapy regimens for dedifferentiated liposarcoma. Note: Any number of non-chemotherapy regimens is permitted.
- •Measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) as defined by RECIST (version 1.1) with at least one measurable lesion.
- •Eastern Cooperative Oncology Group (ECOG) performance status: 0 or
- •Life expectancy ≥6 months.
排除标准
- •Prior treatment with any heat shock protein 90 (Hsp90) inhibitor.
- •Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease
- •Patients with prior hepatic resections or hepatic-directed therapy
- •Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer within 2 weeks prior to dosing.
研究组 & 干预措施
IPI-504
Experimental
IPI 504 administered twice weekly for 2 weeks followed by 1 week off treatment
干预措施: IPI-504 (Drug)
结局指标
主要结局
To determine the safety profile and overall response rate (ORR) of IPI 504 in patients with advanced dedifferentiated liposarcoma.
时间窗: Every 6 weeks
次要结局
- To determine the clinical benefit rate and duration of overall response(Every 6 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
A Study of Transgenic Lymphocyte Immunization (TLI) Against Telomerase in Subjects With Stage III MelanomaStage IIIB Skin MelanomaStage IIIC Skin MelanomaNCT00925314Cosmo Bioscience20
已完成
2 期
Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin LymphomasSmall Lymphocytic LymphomaLymphoplasmacytic LymphomaMarginal Zone LymphomaFollicular LymphomaNCT01282424Gilead Sciences125
已完成
2 期
Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)Chronic Hepatitis BNCT03180619Gilead Sciences124
Unknown
2 期
Endostar + GT in Pulmonary Metastases of Soft Tissue SarcomaSoft Tissue SarcomaNCT01812018Peng Yuan30
进行中（未招募）
2 期
A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)Relapsed/Refractory Small Cell Lung CancerNCT05060016Amgen222