- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00731211
Pazopanib in Previously Treated Patients With Metastatic Renal Cell Carcinoma
2015년 5월 18일 업데이트: SCRI Development Innovations, LLC
A Phase II Trial of Pazopanib in Patients With Metastatic Renal Cell Carcinoma Previously Treated With Sunitinib or Bevacizumab
This is a Phase II, non-randomized, open-label, single-arm study in patients with metastatic renal cell carcinoma who have received one prior targeted therapy with either sunitinib or bevacizumab.
The planned enrollment for this study is 60 patients.
연구 개요
상세 설명
All eligible patients will receive 800 mg of pazopanib orally each day continuously.
Patients will be re-evaluated for treatment response after 8 weeks of daily oral pazopanib therapy.
Response to therapy will be assigned using RECIST criteria (Section 6.0) Patients who have objective response or stable disease will continue treatment with evaluations every 8 weeks, until the time of tumor progression or intolerable treatment-related side effects.
연구 유형
중재적
등록 (실제)
57
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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San Francisco, California, 미국, 94115
- San Francisco Oncology Associates
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Florida
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Fort Myers, Florida, 미국, 33901
- Florida Cancer Specialists
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Lakeland, Florida, 미국, 33805
- Watson Clinic Center for Cancer Care and Research
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Orlando, Florida, 미국, 32804
- Florida Hospital Cancer Institute
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St. Petersburg, Florida, 미국, 33705
- Gulfcoast Oncology Associates
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Georgia
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Augusta, Georgia, 미국, 30901
- Medical Oncology Associates of Augusta
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Gainesville, Georgia, 미국, 30501
- Northeast Georgia Medical Center
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Kentucky
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Louisville, Kentucky, 미국, 40207
- Baptist Hospital East
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Maine
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Lewiston, Maine, 미국, 04240
- Central Maine Medical Center
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Michigan
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Grand Rapids, Michigan, 미국, 49503
- Grand Rapids Clinical Oncology Program
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Missouri
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Chesterfield, Missouri, 미국, 63017
- St. Louis Cancer Care
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Nebraska
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Omaha, Nebraska, 미국, 68198
- University of Nebraska Medical Center
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Ohio
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Cincinnati, Ohio, 미국, 45242
- Oncology Hematology Care
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South Carolina
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Columbia, South Carolina, 미국, 29210
- South Carolina Oncology Associates, PA
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Tennessee
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Chattanooga, Tennessee, 미국, 37404
- Chattanooga Oncology Hematology Associates
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Nashville, Tennessee, 미국, 37023
- Tennessee Oncology, PLLC
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Virginia
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Richmond, Virginia, 미국, 23235
- Virginia Cancer Institute
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- All patients must have histologically documented metastatic or unresectable locally recurrent clear cell renal carcinoma. In patients with mixed histologies, any percentage of clear cell histology is acceptable.
- Patients must have had only one previous targeted agent therapy with either sunitinib or bevacizumab. Patients must have progressed either during or within 3 months of discontinuing treatment with one of these agents. Patients who stopped either sunitinib or bevacizumab because of unacceptable toxicity are also eligible.
- Patients may have received one previous regimen containing traditional immunotherapy (interferon, interleukin-2), chemotherapy, or combination chemoimmunotherapy for metastatic disease.
- Previous nephrectomy is required unless clinically contraindicated (e.g. extensive liver or bone metastases; primary tumor <5cm).
- An ECOG performance status of 0 or 1.
- At least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques, or as >10 mm with spiral computerized tomography (CT) scan according to the Response Evaluation Criteria in Solid Tumors (RECIST).
- Absolute neutrophil count (ANC) >1500; platelets >75,000 (within 7 days prior to study treatment).
- Adequate liver function as measured by serum bilirubin <1.5 mg/dL and AST/ALT <2.5 times upper limit of normal (ULN) (or <5 x ULN in patients with documented liver metastases).
- Serum creatinine <2.0 mg/dL.
- Patients must be able to understand the nature of this study and give written informed consent.
Exclusion Criteria:
- Previous treatment with more than one targeted agent, or more than one previous traditional regimen (e.g., chemotherapy, immunotherapy, chemoimmunotherapy).
- Previous treatment with sorafenib, temsirolimus, everolimus or other investigational targeted agents.
- Inability to swallow and retain oral medication.
- History of other malignancy. Patients who have been disease-free for 5 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
- Concurrent disease or condition that would make the patient inappropriate for study participation including: (1) any unresolved or unstable serious toxicity from prior administration of another drug, or (2) any serious medical disorder that would interfere with the patient's safety, obtaining informed consent, or compliance with the study.
- History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously treated parenchymal CNS metastases, are asymptomatic, and have had no requirement for steroids or anticonvulsants for >2 months prior to study enrollment. Routine screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated, or if the patient has a history of CNS metastases.
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
- Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to beginning therapy.
- Presence of uncontrolled infection.
- Concurrent cancer therapy (e.g., chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, or tumor embolization).
- Concurrent treatment with an investigational agent or participation in another clinical trial.
- Use of an investigational anti-cancer drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of pazopanib.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.
- Has taken or is taking prohibited medications.
- Corrected QT interval (QTc) prolongation defined as QTc interval >470 msec.
History of any one of the following cardiac conditions within the past 6 months:
- Cardiac angioplasty or stenting
- Myocardial infarction
- Unstable angina
- History of cerebrovascular accident within the past 6 months
- Poorly controlled hypertension (systolic blood pressure [SBP] of >140 mmHg, or diastolic blood pressure [DBP] of >90 mmHg).
Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. The blood pressure (BP) must be re- assessed on two occasions that are separated by a minimum of 24 hours. The mean SBP-DBP values from both BP assessments must be <140/90 mmHg in order for a patient to be eligible for the study.
- Presence of any non-healing wound, fracture, or ulcer, or the presence of symptomatic peripheral vascular disease.
- Evidence of bleeding diathesis or coagulopathy.
- Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study. Minor surgical procedures such as fine needle aspiration or core biopsy within 1 week prior to beginning therapy are also excluded.
- Pregnant or lactating female. All patients of childbearing potential must agree to use adequate contraception for 2 weeks prior to beginning pazopanib, during the entire study, and for 60 days after pazopanib is discontinued.
- Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- History of untreated deep venous thrombosis (DVT) within the past 6 months.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Pazopanib
800 mg of pazopanib orally each day continuously
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800 mg of pazopanib orally each day continuously
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall Response Rate
기간: 18 months
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Proportion of patients with complete and partial response (CR and PR).
CR defined as disappearance of target lesions; PR defined as at least a 30% decrease in the sum of the longest diamater of target lesions.
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18 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Progression-free Survival
기간: every 8 weeks until progressive disease, expected average of 18 months
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Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study.
Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
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every 8 weeks until progressive disease, expected average of 18 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 9월 1일
기본 완료 (실제)
2011년 5월 1일
연구 완료 (실제)
2012년 9월 1일
연구 등록 날짜
최초 제출
2008년 8월 5일
QC 기준을 충족하는 최초 제출
2008년 8월 7일
처음 게시됨 (추정)
2008년 8월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 5월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 5월 18일
마지막으로 확인됨
2015년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
신장 세포 암종에 대한 임상 시험
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Sandy SrinivasGlaxoSmithKline완전한방광암 | 방광(요로상피, 이행세포) 암 | 방광(Urothelial, Transitional Cell) 절제 가능한 암(방광절제술 전) | 방광(Urothelial, Transitional Cell) 암 표재성(비침습성) | 방광(Urothelial, Transitional Cell) 암 전이성 또는 절제 불가능미국
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Stanford UniversityNational Institutes of Health (NIH)빼는방광암 | 피부암 | 방광(요로상피, 이행세포) 암 | 방광(Urothelial, Transitional Cell) 절제 가능한 암(방광절제술 전)미국
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Millennium Pharmaceuticals, Inc.완전한GCB(Non-Germinal B-cell-like) 미만성 거대 B-세포 림프종(DLBCL)미국
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SWOG Cancer Research NetworkNational Cancer Institute (NCI); Genentech, Inc.모병미만성 거대 B세포 림프종 | 재발성 미만성 대형 B세포 림프종 | 난치성 미만성 대형 B세포 림프종 | 원발성 종격동(흉선) 대형 B세포 림프종 | 등급 3b 여포성 림프종 | 변형된 여포 림프를 Diff 대형 B-세포 림프종으로 | 변형된 마그 존 림프를 Diff Large B-Cell Lymphoma로미국
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University of Alabama at Birmingham종료됨역형성 대세포 림프종 | 혈관면역모세포성 T세포 림프종 | 말초 T 세포 림프종 | 성인 T 세포 백혈병 | 성인 T 세포 림프종 | 상세불명의 말초 T 세포 림프종 | T/Null Cell 전신형 | 림프절/내장 질환을 동반한 피부 T세포 림프종미국
Pazopanib에 대한 임상 시험
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Pfizer완전한전이성 신장 세포 암종(mRCC)스페인, 이탈리아, 벨기에, 프랑스, 영국, 오스트리아, 그리스, 네덜란드