- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01249521
Dual Targeting of Vascular Endothelial Growth Factor-A Together With Angiopoietins in Chemotherapy-naïve Metastatic Colorectal Cancer (Vengeance)
Open Label Phase II Study Evaluating the Combination of Bevacizumab and AMG386 Without Chemotherapy as First Line Treatment of Advanced Colorectal Cancer
This is a clinical trial investigating the effectiveness and safety of the combination of the study drugs bevacizumab and AMG386 in patients with advanced (metastatic) chemotherapy-naive bowel (colorectal) cancer. Chemotherapy has a significant impact in metastatic bowel cancer in terms of maintenance of quality of life and extension of survival. However, ultimately tumours will develop resistance to these agents and further treatment options are urgently required.
Angiogenesis is a process that results in the formation of new blood vessels. Similar to normal tissues, solid tumours require new blood vessels for growth and survival. Hence, drugs targeting angiogenesis may be useful treatment options for patients with bowel cancer.
AMG386 and bevacizumab act on 2 different pathways relevant to angiogenesis. There is evidence from laboratory and animal studies to suggest that such a combination could be useful as a cancer treatment. Previous studies in humans have shown that AMG386 and bevacizumab can be combined safely.. This study aims to evaluate the effectiveness and safety of the combination of AMG386 and bevacizumab in patients with advanced bowel cancer.
40 patients from approximately four hospitals in Australia will participate in this trial, with approximately 20 patients being enrolled at Austin Health. All participants will receive the same treatment.
연구 개요
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Effie Skrinos
- 전화번호: +61394963576
- 이메일: effie.skrinos@austin.org.au
연구 장소
-
-
Victoria
-
Melbourne, Victoria, 호주, 3084
- 모병
- Austin Health
-
수석 연구원:
- Niall Tebbutt
-
연락하다:
- Effie Skrinos
- 전화번호: +61394963576
- 이메일: effie.skrinos@austin.org.au
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
i) Histological diagnosis of colorectal cancer ii) Metastatic disease that is not resectable iii) Age > 18 years iv) Any patient in whom the investigator considers immediate cytotoxic chemotherapy is not required.
v) Measurable and/or non-measurable disease as assessed by CT scan vi) ECOG performance status 0, 1 or 2. vii) No prior chemotherapy except for adjuvant chemotherapy. viii) Adequate bone marrow function with platelets > 100 X 109/l; neutrophils > 1.5 X 109/l ix) Adequate renal function, with calculated creatinine clearance >40 ml/min (Cockcroft and Gault).
x) Adequate hepatic function with serum total bilirubin < 1.5 X upper limit of normal range xi) Life expectancy of at least 12 weeks xii) No other concurrent uncontrolled medical conditions xiii) No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other cancer treated with curative intent >2 years previously without evidence of relapse xiv) Women and partners of women of childbearing potential must agree to use adequate contraception xv) Written informed consent including consent for biomarker studies
Exclusion Criteria:
i) Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol ii) Uncontrolled hypertension iii) Prior treatment with VEGF inhibitors or angiopoietin inhibitors iv) Active bleeding disorders within the last 6 months v) Participation in any investigational drug study within the previous 4 weeks vi) Patients with uncontrolled clinically significant cardiac disease, arrhythmias or angina pectoris vii) Patients with a history of arterial or venous thrombosis within the last 12 months viii) Concurrent or prior (within 1 week before enrollment) anticoagulation therapy. The concurrent use of low molecular weight heparin or low dose warfarin (ie, 1 mg daily) for prophylaxis against thrombosis is acceptable while on study ix) Regular use of aspirin (>325mg/day) or NSAIDs (low dose aspirin (<325 mg/d), or occasional use of NSAIDs is acceptable) x) Treatment with immune modulators such as cyclosporine or tacrolimus within the previous 4 weeks xi) CNS metastases xii) Major surgical procedure within the last 28 days xiii) Minor surgical procedure, placement of access device, or fine needle aspiration within the last 7 days xiv) Serious non-healing wound, ulcer or bone fracture xv) 24 hour urinary protein > 1g/ 24 hours ( performed if urine dipstick > 1+ ) xvi) Pregnancy or lactation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Disease control (ie non progression) at 6 months
기간: 6 months
|
6 months
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
독성
기간: 주간
|
주간
|
응답률
기간: 6주
|
6주
|
Overall survival
기간: 3 monthly
|
3 monthly
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Niall Tebbutt, Austin Health
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .
전이성 대장암에 대한 임상 시험
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
-
University of UtahNational Cancer Institute (NCI)모병피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8미국
-
Jonsson Comprehensive Cancer Center아직 모집하지 않음전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Rashmi Verma, MDNational Cancer Institute (NCI)모병거세저항성 전립선암 | 전이성 전립선 선암종 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterMiraDX모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center종료됨거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.종료됨2기 전립선암 AJCC v8 | IIIA기 전립선암 AJCC v8 | IIIB기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | 3기 전립선암 AJCC v8 | IIIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center종료됨생화학적으로 재발하는 전립선암 | 전이성 전립선암 | 뼈의 전이성 악성 신생물 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Assiut University아직 모집하지 않음South Egypt Cancer Institute(SECI)에서 소아 악성종양 환자에 대한 KDIGO 기준을 사용하여 AKI의 누적 발병률을 확인하기 위해
AMG386 and bevacizumab에 대한 임상 시험
-
University of OregonSpecial X Inc.모병부모-자녀 관계 | 육아 | 아동 행동 | 발달 장애 | 개발 지연 | 발달 장애, 아동미국
-
University Hospitals Cleveland Medical Center알려지지 않은
-
San Diego State UniversityRady Children's Hospital, San Diego알려지지 않은
-
Istituto per la Ricerca e l'Innovazione BiomedicaFondazione di Comunità di Messina onlus모병
-
GenSight Biologics모병
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Splendor-NC모병비만 | 초과 중량 | 체중 | 체중 감량 | 체중 변화 | 만성 질환 | 과체중 및 비만 | 신체 활동 부족 | 행동, 식사 | 중량 감소미국
-
Dalarna UniversityUppsala University; The Swedish Research Council모병백치 | 가벼운 인지 장애 | 치매, 혼합 | 알츠하이머형 치매 | 주관적 인지 장애 | 치매 노인성스웨덴
-
Children's National Research InstituteAppleTree Institute; The Maddux School초대로 등록
-
Northwestern UniversityUniversity of Michigan; The University of Texas Health Science Center at San Antonio; University... 그리고 다른 협력자들완전한
-
Polares Medical SAPolares Medical, Inc.아직 모집하지 않음