A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).
2015년 5월 22일 업데이트: Hoffmann-La Roche
An Open Label Study of the Effect of First Line Treatment With Avastin (Bevacizumab) in Combination With Low-dose Interferon on Progression-free Survival in Patients With Metastatic Clear Cell Renal Cell Carcinoma.
This single arm study will assess progression free survival, tumor response and safety of Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with metastatic clear cell renal cell carcinoma.
Patients will receive Avastin (10mg/kg iv) every 2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week (t.i.w.).
The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
연구 개요
연구 유형
중재적
등록 (실제)
146
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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Larissa, 그리스, 41 110
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Thessaloniki, 그리스, 56429
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Thessaloniki, 그리스, 54639
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Amstelveen, 네덜란드, 1186 AH
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Eindhoven, 네덜란드, 5623 EJ
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Maastricht, 네덜란드, 6229 HX
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Nijmegen, 네덜란드, 6525 GA
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Arnsberg, 독일, 59755
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Augsburg, 독일, 86156
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Berlin, 독일, 10117
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Berlin, 독일, 13055
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Freiburg, 독일, 79106
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Homburg/Saar, 독일, 66424
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Leipzig, 독일, 04103
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München, 독일, 81241
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Münster, 독일, 48149
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Offenburg, 독일, 77652
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Planegg, 독일, 82152
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Stuttgart, 독일, 70174
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Weiden, 독일, 92637
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Barnaul, 러시아 연방, 656049
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Ekaterinburg, 러시아 연방, 620102
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Moscow, 러시아 연방, 125284
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Moscow, 러시아 연방, 115478
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Moscow, 러시아 연방, 117837
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Obninsk, 러시아 연방, 249020
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St Petersburg, 러시아 연방
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UFA, 러시아 연방, 450054
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Ulyanovsk, 러시아 연방, 432063
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Kaunas, 리투아니아, 50009
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Vilnius, 리투아니아, 08661
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Eskilstuna, 스웨덴, 63188
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Linkoeping, 스웨덴, 58185
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Sundsvall, 스웨덴, 85186
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Vaxjo, 스웨덴, 35185
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Aarau, 스위스, 5000
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Locarno, 스위스, 6601
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Zürich, 스위스, 8063
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Tallinn, 에스토니아, 13419
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Tallinn, 에스토니아, 10617
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Tartu, 에스토니아, 50406
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Cambridge, 영국, CB2 2QQ
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Cardiff, 영국, CF14 2TL
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Milano, 이탈리아, 20100
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Napoli, 이탈리아, 80131
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Pisa, 이탈리아, 56100
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Olomouc, 체코 공화국, 775 20
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Praha 2, 체코 공화국, 128 08
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Seinäjoki, 핀란드, 60220
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Turku, 핀란드, 20520
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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:
- adult patients, >=18 years of age;
- metastatic RCC with majority (>50%) of conventional clear-cell type;
- prior total nephrectomy for primary RCC;
- at least one measurable or non-measurable lesions;
- ECOG performance score of 0 or 2.
Exclusion Criteria:
- prior systemic treatment for metastatic RCC;
- current or previously treated but non-stable CNS metastases or spinal cord compression;
- major surgery (including open biopsy) or radiation therapy within 28 days prior to enrollment;
- significant cardiovascular disease within 6 months prior to enrollment.
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: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 1
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10mg/kg iv infusion every 2 weeks
3 MIU sc t.i.w.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months
기간: 12 and 24 months
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PFS at 12 and 24 months is an estimate of the percentages of participants expected to be progression free at 12 and 24 months based on Kaplan-Meier survival analysis of the PFS data.
PFS was defined as the time period from the first postbaseline tumor assessment to evidence of disease progression or death from any cause, whichever occurred first.
Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason.
Censoring at start of any subsequent antineoplastic therapy was not performed.
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12 and 24 months
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PFS - Percentage of Participants With an Event
기간: Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
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PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first.
Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason.
Censoring at start of any subsequent antineoplastic therapy was not performed.
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Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
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PFS - Time to Event
기간: Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
|
PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first.
Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason.
Censoring at start of any subsequent antineoplastic therapy was not performed.
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Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR)
기간: Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
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Percentage of participants with objective response, termed responders, based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST).
Confirmed responses were those that persisted on repeat imaging study greater than or equal to (≥)4 weeks after initial documentation of response.
CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease.
All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]).
No new lesions.
PR was defined as ≥30 percent (%) decrease under baseline of the sum of diameters of all target lesions.
The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.
No unequivocal progression of non-target disease.
No new lesions.
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Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
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Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months
기간: Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
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OS at 12 and 24 months is the estimate of the percentages of participants expected to alive at 12 and 24 months based on Kaplan-Meier survival analysis of the survival data.
Median OS was defined as the time period from the first bevacizumab infusion to death from any cause.
Censoring at start of any subsequent antineoplastic therapy was not performed.
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Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
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OS - Percentage of Participants With an Event
기간: Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
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OS was defined as the time period from the first bevacizumab infusion to death from any cause.
Censoring at start of any subsequent antineoplastic therapy was not performed.
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Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
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OS - Time to Event
기간: Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
|
OS was defined as the time period from the first bevacizumab infusion to death from any cause.
Censoring at start of any subsequent antineoplastic therapy was not performed.
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Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
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Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit
기간: Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and End of Treatment (EOT)
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EQ-5D is a standardized, participant-administered measure of health outcome.
It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best).
Answers from the questionnaire for each dimension (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) was classified into one of 2 categories: 'no problems' or 'any problems', and the percentage of participants in each category was determined.
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Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and End of Treatment (EOT)
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EQ-5D - Visual Analog Scale (VAS)
기간: Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and EOT
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EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 millimeters (mm) (best imaginable health state); higher scores indicate a better health state.
Participants were asked to rate their health state and mark the line; the distance from the left edge was recorded.
For change from baseline a negative value represents a worsening in the health state and a positive value represents an improvement in the health state.
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Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and EOT
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간행물 및 유용한 링크
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연구 기록 날짜
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연구 주요 날짜
연구 시작
2008년 12월 1일
기본 완료 (실제)
2012년 2월 1일
연구 완료 (실제)
2012년 2월 1일
연구 등록 날짜
최초 제출
2008년 11월 21일
QC 기준을 충족하는 최초 제출
2008년 11월 21일
처음 게시됨 (추정)
2008년 11월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 5월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 5월 22일
마지막으로 확인됨
2015년 5월 1일
추가 정보
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