EUCTR2009-017261-32-DE进行中（未招募）1 期
Phase II randomized clinical trial of Pazopanib alone and Pazopanib plus Gemcitabine in relapsed or metastatic soft tissue sarcoma - PAPAGEMO
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Histologically or cytological confirmed malignant soft tissue sarcoma including any subtypes except:
- •oChondrosarcoma
- •oOsteosarcoma
- •oEwing tumors and primitive neuroectodermal tumors
- •oGastrointestinal stromal tumors
- •oDermofibromatosis sarcoma protuberans
- •oInflammatory myofibroblastic sarcoma
- •oMalignant mesothelioma
- •oMixed mesodermal tumors of the uterus
- •2.Patient must have received at least one prior chemotherapy including either an antrazyclin or ifosfamide or both.
- •3.ECOG performance status 0-2
- •4.At least 18 years old
- •5.Life expectancy > 3 months
- •6.Patients with at least one measurable lesion according to RECIST criteria (v1.1)
- •7.Able to swallow and retain oral medication
- •8.Adequate organ function as defined in protocol
- •9.A female is eligible to enter and participate in this study if she is either of non childbearing potential (defined in protocol) or childbearing potential with negativ pregnancy test within 2 weeks prior to the first dose of study and agrees to use adequate contraception (as defined in protocol)
- •10.Signed, written informed consent, willingness to comply with the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 81
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •1.Patient has received prior treatment with any anti angiogenic drug (including bevacizumab and tyrosine kinase inhibitors)
- •2.Active malignancy or any malignancy in the last 5 years prior to first dose of study drug other than STS.
- •3.History of clinical evidence of CNS metastases or leptomeningeal carcinomatosis (more information see protocol)
- •4.Clinically significant gastrointestinal disorders/ abnormalities (defined in protocol)
- •5.Poorly controlled hypertension (defined in protocol)
- •6.Prolongation of corrected QT interval (QTc) > 480msec
- •7.Clinically significant cardiovascular disease, for example Cerebrovascular accident, myocardial infarction (equal or lower than 6 months before treatment start), unstable angina, NYHA Class II CHF, arrhythmia requiring medication
- •8.Major surgery or trauma within 28 days or any non- healing wound, fracture or ulcer
- •9.Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to Pazopanib or Gemcitabine
- •10.Presence of uncontrolled infection
- •11.Women who are pregnant or breast feeding
- •12.Treatment with any other cancer therapies within 14 days prior to the first dose of study drug (defined in protocol)
- •13.Evidence of active bleeding or bleeding diathesis
- •14.Hemoptysis in excess of 2.5 mL (or one half teaspoon) within 8 weeks of first dose of study drug.
- •15.Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
- •16.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
- •17.History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
- •18.Unable or unwilling to discontinue use of prohibited medications listed in the protocol for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study
- •19.Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
研究者
相似试验
已完成
2 期
Phase II randomized clinical trial of Pazopanib alone and Pazopanib plus Gemcitabine in relapsed or metastatic soft tissue sarcomarelapsed or metastatic soft tissue sarcomaC49Malignant neoplasm of other connective and soft tissueDRKS00003139niversitätsklinikum Halle (Saale)90
进行中（未招募）
1 期
Activity and tolerability of Pazopanib in advanced and/or metastatic liposarcoma. A phase II clinical trial.Advanced and/or metastatic liposarcomaMedDRA version: 17.1Level: PTClassification code 10024629Term: Liposarcoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1Level: PTClassification code 10024627Term: LiposarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-002745-38-DEGrupo Español de Investigacion en Sarcomas74
已完成
2 期
Phase II clinical study of concurrent Pazopanib for non-metastatic Sarcoma patients to be treated with Radiotherapy, localized in the extremities, trunk and chest wall or the head and neck region.soft tissue tumor10028389sarcomaNL-OMON47205Antoni van Leeuwenhoek Ziekenhuis27
进行中（未招募）
1 期
PASART 2soft tissue sarcomaMedDRA version: 19.0Level: HLTClassification code 10041298Term: Soft tissue sarcomas histology unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10024627Term: LiposarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10016632Term: FibrosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10049067Term: Spindle cell sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10024189Term: LeiomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-004134-95-GBThe Netherlands Cancer Institute35
进行中（未招募）
不适用
Fase II onderzoek waarin de effectiviteit van 800 mg pazopanib in tabletvorm toegevoegd aan de standaard 25x bestraling wordt onderzocht, bij patiënten met weke delen tumoren in de armen of benen, de borstkas of buikwand en het hoofd/hals gebied (PASART-2)Phase II study to investigate the efficacy of adding 800 mg oral pazopanib to standard 25 x 2 Gy radiotherapy at patients with non-metastatic SArcoma patients lokalized in the extremities, trunk and chest wall or in the head and neck regionon-metastatic sarcoma patients localized in the extremities, trunk and chest wall or the head and neck regionMedDRA version: 18.1Level: PTClassification code 10039491Term: SarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: LLTClassification code 10039492Term: Sarcoma boneSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-004134-95-NLThe Netherlands Cancer Institute35