NCT02207309终止2 期
A Randomized, Double Blind, Phase II Trial of Pazopanib Versus Placebo as Maintenance Therapy in Patients With Retroperitoneal and Visceral High-risk Soft Tissue Sarcomas Following Prior Neo- and/or Adjuvant Doxorubicin / Ifosfamide Chemotherapy With Regional Hyperthermia
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
- 1
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This trial compares pazopanib to placebo as maintenance treatment over 2 years in patients with retroperitoneal and visceral high-risk soft tissue sarcomas after multimodal treatment including prior neo- and/or adjuvant doxorubicin / ifosfamide chemotherapy with regional hyperthermia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
- •Patients must have histological evidence of high-grade soft tissue sarcoma (grade 2 - 3) according to the FNLCC grading system, tumor size ≥ 5 cm and deep localization with regard to the superficial fascia, excluding the following tumor types:
- •Embryonal rhabdomyosarcoma
- •Chondrosarcoma (excluding extraskeletal myxoid chondrosarcoma)
- •Osteosarcoma (excluding extraskeletal osteosarcoma)
- •Ewing tumors / primitive neuroectodermal tumor (PNET)
- •Gastro-intestinal stromal tumors (GIST)
- •Dermatofibrosarcoma protuberans
- •Patients who had undergone previous surgery with inadequate margins (tumour-free margins ≤1 cm or margins contaminated) are eligible if thermochemotherapy has been started within 8 weeks after surgery
- •Unstained slides and ideally tumour blocks must be available for histological central review
- •Completed 4 to 8 cycles of thermochemotherapy with doxorubicin and ifosfamide at least 21 days but no more than 42 days prior to study entry
- •No evidence of disease following completion of first-line thermochemotherapy and within ≤ 21 days of study entry
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •No other prior chemotherapy except thermochemotherapy with doxorubicin and ifosfamide
- •Adequate organ system function
排除标准
- •No prior or concurrent second primary malignant tumors (except adequately treated in situ carcinoma of cervix, or basal cell carcinoma)
- •No symptomatic or known Central nervous system (CNS) metastases at baseline
- •Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
- •Active peptic ulcer disease
- •Known intraluminal metastatic lesion/s with risk of bleeding
- •Inflammatory bowel disease (e.g. ulcerative colitis, Chrohn's disease), or other gastrointestinal conditions with increased risk of perforation
- •History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
- •Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
- •Malabsorption syndrome
- •Major resection of the stomach or small bowel.
- •Corrected QT interval (QTc) > 480 msecs
- •History of any one or more of the following cardiovascular conditions within the past 6 months:
- •Cardiac angioplasty or stenting
- •Myocardial infarction
- •Unstable angina
- •Coronary artery bypass graft surgery
- •Symptomatic peripheral vascular disease
- •Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) (See Appendix D for description)
- •Poorly controlled hypertension (SBP of ≤ 150 mmHg or DBP of ≤95 mmHg is acceptable provided that BP will be treated and monitored at least weekly. The goal is to attain controlled hypertension within 4 weeks of start of IMP which is defined as grade ≤1 hypertension CTCAE Version 4.0)
- •NYHA II at Screening for Patients > 65 years
- •History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- •Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
- •Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery).
- •Evidence of active bleeding or bleeding diathesis.
- •Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage Note: Lesions infiltrating major pulmonary vessels (contiguous tumour and vessels) are excluded; however, the presence of a tumor that is touching, but not infiltrating (abutting) the vessels is acceptable (CT with contrast is strongly recommended to evaluate such lesions).
- •Large protruding endobronchial lesions in the main or lobar bronchi are excluded; however, endobronchial lesions in the segmented bronchi are allowed.
- •Lesions extensively infiltrating the main or lobar bronchi are excluded; however, minor infiltrations in the wall of the bronchi are allowed.
- •Recent hemoptysis (≥½ teaspoon of red blood within 8 weeks before first dose of study drug).
- •Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
- •Treatment with any of the following anti-cancer therapies:
- •radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR
- •chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
- •Administration of any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment
- •Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia
研究组 & 干预措施
Pazopanib
Active Comparator
800mg, oral, 24 months
干预措施: Pazopanib (Drug)
Placebo
Placebo Comparator
800mg, oral, 24 months
干预措施: Placebo (for Pazopanib) (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Study Start Dat: June 22, 2015; Study Completion Date: July 29, 2016 ; an approximate study duration of 13 months
The study could not be evaluated. Only one patient was included.
次要结局
- Overall Survival (OS)(Study Start Dat: June 22, 2015; Study Completion Date: July 29, 2016 ; an approximate study duration of 13 months)
研究者
Lars Lindner
PD Dr. med.
Ludwig-Maximilians - University of Munich
研究点 (1)
Loading locations...
相似试验
未知
2 期
Phase II Study of KRP-AB1102JPRN-jRCT2080221867Kyorin Pharmaceutical Co., LTD.360
进行中（未招募）
不适用
A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple SclerosisCentral Neuropathic Pain in Multiple SclerosisMedDRA version: 15.1Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 100000004852EUCTR2011-002178-22-PLAvanir Pharmaceuticals, Inc.400
进行中（未招募）
1 期
To evaluate how well study drug LX9211 is in reducing pain related to postherpetic neuralgia (PHN), a painful condition that affects the nerve fibers and skin (shingles).Postherpetic NeuralgiaMedDRA version: 21.1Level: PTClassification code 10036376Term: Post herpetic neuralgiaSystem Organ Class: 10029205 - Nervous system disordersEUCTR2020-004639-26-PLexicon Pharmaceuticals, Inc.74
进行中（未招募）
1 期
To evaluate how well study drug LX9211 is in reducing pain related to postherpetic neuralgia (PHN), a painful condition that affects the nerve fibers and skin (shingles).MedDRA version: 21.1Level: PTClassification code 10036376Term: Post herpetic neuralgiaSystem Organ Class: 10029205 - Nervous system disordersPostherpetic NeuralgiaEUCTR2020-004639-26-CZexicon Pharmaceuticals, Inc.74
进行中（未招募）
1 期
A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple SclerosisEUCTR2011-002178-22-GBAvanir Pharmaceuticals, Inc.400