EUCTR2011-000259-17-DE进行中（未招募）1 期
A phase I/II study of Pazopanib and weeklyTopotecan in patients with platinum-resistant orintermediate-sensitive recurrent ovarian cancer - TOPAZ
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
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
- Female
入选标准
- •1. Patients 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
- •assessments and procedures.
- •2. Histologically confirmed diagnosis of epithelian ovarian
- •cancer, primary peritoneal carcinoma or fallopian tube
- •3. Patients must have platinum resistant (recurrence within 6
- •months of a platinum-containing regimen) or platinum
- •refractory (progression during platinum treatment) or
- •intermediate platinum-sensitive (recurrence within 12
- •months after a platinum-based primary therapy) disease.
- •4. No more than 2 prior treatment regimens for epithelial
- •ovarian cancer
- •5. Age ³18 years
- •6. Eastern Cooperative Oncology Group (ECOG)
- •performance status of 0 or 1
- •7. Adequate organ function defined as in the table below.
- •8. There must be measurable disease or evaluable disease
- •according to RECIST criteria.
- •9. Able to swallow and retain oral medication.
- •10. A life expectancy of at least 12 weeks.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •11. Prior malignancies; subject who have had another
- •malignancy and have been disease-free for 5 years which
- •effect progression free survival, or subject with a history of
- •completely resected non-melanomatous skin carcinoma or
- •successfully treated in situ carcinoma are eligible
- •12. History or clinical evidence of central nervous system
- •(CNS) metastases or leptomeningeal carcinomatosis,
- •except for individuals who have previously-treated CNS
- •metastases, are asymptomatic, and have had no
- •requirement for steroids or anti-seizure medication for 6
- •months prior to first dose of study drug. Screening with
- •CNS imaging studies (computed tomography [CT] or
- •magnetic resonance imaging [MRI]) is required only if
- •clinically indicated or if the subject has a history of CNS
- •metastases.
- •13. Clinically significant gastrointestinal abnormalities that
- •might interfere with oral dosing or that may increase the
- •risk for gastrointestinal bleeding including, but not limited
- •Active peptic ulcer disease
- •Known intraluminal metastatic lesion/s with suspected
- •Inflammatory bowel disease (e.g. ulcerative colitis,
- •Crohn’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
- •14. 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
- •15. Grade 3 or 4 diarrhoea
- •16. Any unstable or serious concurrent condition (e.g., active
- •infection requiring systemic therapy).
- •17. Poorly controlled hypertension [defined as systolic blood
- •pressure (SBP) of =140 mmHg or diastolic blood pressure
- •(DBP) of = 90mmHg].
- •Note: Initiation or adjustment of antihypertensive medication(s) is
- •permitted prior to study entry. BP must be re-assessed on two
- •occasions that are separated by a minimum of 1 hour; on each of
- •these occasions, the mean (of 3 readings) SBP / DBP values
- •from each BP assessment must be <140/90 mmHg in order for a
- •subject to be eligible for the study
- •18. Prolongation of corrected QT interval (QTc) >480 msecs
- •using Bazett’s formula.
- •19. History of any one or more of the following cardiovascular conditions within the past 6 months:
- •Cardiac angioplasty or stenting
- •Myocardial infarction
- •Unstable angina
- •Symptomatic peripheral vascular disease
- 另有 21 项未显示
研究者
相似试验
进行中（未招募）
1 期
Pazopanib Pediatric Phase II Trial Children's Oncology Group in Solid TumorsRhabdomyosarcoma, non-rhabdomyosarcomatous soft tissue sarcoma (including synovial sarcoma, alveolar soft part sarcoma and desmoplastic small round cell tumor), Ewing sarcoma/peripheral Primitive Neuro Ectodermal Tumor (PNET), hepatoblastoma, neuroblastoma (measurable and evaluable), and osteosarcomaMedDRA version: 20.0 Level: HLT Classification code 10019825 Term: Hepatoblastomas System Organ Class: 100000005101MedDRA version: 20.0 Level: PT Classification code 10029260 Term: Neuroblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.1 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas System Organ Class: 100000004864MedDRA version: 20.0 Level: PT Classification code 10031291 Term: Osteosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: HLT Classification code 10039023 Term: Rhabdomyosarcomas System Organ Class: 100000143528MedDRA version: 20.0 Level: PT Classification code 10015560 Term: Ewing's sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003595-12-CZovartis Pharma Services AG154
进行中（未招募）
1 期
Pazopanib Pediatric Phase II Trial Children's Oncology Group in Solid TumorsRhabdomyosarcoma, non-rhabdomyosarcomatous soft tissue sarcoma (including synovial sarcoma, alveolar soft part sarcoma and desmoplastic small round cell tumor), Ewing sarcoma/peripheral Primitive Neuro Ectodermal Tumor (PNET), hepatoblastoma, neuroblastoma (measurable and evaluable), and osteosarcomaMedDRA version: 20.0 Level: HLT Classification code 10019825 Term: Hepatoblastomas System Organ Class: 100000005101MedDRA version: 20.0 Level: PT Classification code 10029260 Term: Neuroblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.1 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas System Organ Class: 100000004864MedDRA version: 20.0 Level: PT Classification code 10031291 Term: Osteosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: HLT Classification code 10039023 Term: Rhabdomyosarcomas System Organ Class: 100000143528MedDRA version: 20.0 Level: PT Classification code 10015560 Term: Ewing's sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003595-12-ESovartis Farmacéutica, S.A.154
进行中（未招募）
1 期
Pazopanib Pediatric Phase II Trial Children's Oncology Group in Solid TumorsRhabdomyosarcoma, non-rhabdomyosarcomatous soft tissue sarcoma (including synovial sarcoma, alveolar soft part sarcoma and desmoplastic small round cell tumor), Ewing sarcoma/peripheral Primitive Neuro Ectodermal Tumor (PNET), hepatoblastoma, neuroblastoma (measurable and evaluable), and osteosarcomaMedDRA version: 20.0Level: HLTClassification code 10019825Term: HepatoblastomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10029260Term: NeuroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10031291Term: OsteosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10039023Term: RhabdomyosarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10015560Term: Ewing's sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003595-12-FRovartis Pharma Services AG154
进行中（未招募）
1 期
Pazopanib Pediatric Phase II Trial Children's Oncology Group in Solid TumorsRhabdomyosarcoma, non-rhabdomyosarcomatous soft tissue sarcoma (including synovial sarcoma, alveolar soft part sarcoma and desmoplastic small round cell tumor), Ewing sarcoma/peripheral Primitive Neuro Ectodermal Tumor (PNET), hepatoblastoma, neuroblastoma (measurable and evaluable), and osteosarcomaMedDRA version: 20.0Level: HLTClassification code 10019825Term: HepatoblastomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10029260Term: NeuroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10031291Term: OsteosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10039023Term: RhabdomyosarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10015560Term: Ewing's sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003595-12-HUovartis Pharma Services AG154
进行中（未招募）
1 期
Pazopanib Pediatric Phase II Trial Children's Oncology Group in Solid TumorsRhabdomyosarcoma, non-rhabdomyosarcomatous soft tissue sarcoma (including synovial sarcoma, alveolar soft part sarcoma and desmoplastic small round cell tumor), Ewing sarcoma/peripheral Primitive Neuro Ectodermal Tumor (PNET), hepatoblastoma, neuroblastoma (measurable and evaluable), and osteosarcomaMedDRA version: 20.0 Level: HLT Classification code 10019825 Term: Hepatoblastomas System Organ Class: 100000005101MedDRA version: 20.0 Level: PT Classification code 10029260 Term: Neuroblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.1 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas System Organ Class: 100000004864MedDRA version: 20.0 Level: PT Classification code 10031291 Term: Osteosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: HLT Classification code 10039023 Term: Rhabdomyosarcomas System Organ Class: 100000143528MedDRA version: 20.0 Level: PT Classification code 10015560 Term: Ewing's sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003595-12-SKovartis Pharma Services AG154