- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00872404
A Study of CP-751,871 in Patients With Recurrent Squamous Head and Neck Carcinoma
A Phase II Study of CP-751,871 in Patients With Recurrent and/or Metastatic Squamous Head and Neck Carcinoma
연구 개요
상세 설명
CP-751,871 will be administered as an open-label intravenous solution. All patients will be treated every 3 weeks until disease progression(by RECIST criteria) or unacceptable toxicity death or discontinuation from the study for any other reason.
Since, head and neck tumors are easily accessible for iterative biopsy, this study will offer the opportunity to get tumor biopsies before and after CP-751,871. Our study will allow translational research with biopsies at crucial timing:
(i) at baseline before any treatment, (ii) during the treatment with CP-751,871 (day 1, second cycle two hours after the injection of CP-751,871).
(iii) for patients with stable disease or partial response, a new biopsy will be performed at the time of disease progression to try to understand the mechanisms of tumor resistance.
The baseline samples will allow an investigation of molecular profiles that reflect an inherent inter-patient variability and which will be predictive of response. Although the number of patients included is low, these data may contribute to understand the mechanisms of response and non-response to CP-751,871. Understanding the mechanisms of response to CP-751,871 will help in the rational design of further clinical trials in head and neck cancer using CP-751,871.
The on-treatment samples will help to dynamically monitor the molecular response to CP-751,871.
The study of involved pathways before and after administration of CP-751,871 could be performed using IHC, DNA sequence analysis and RNA expression profiling. Plasma samples could be also stored for further analysis.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Bruxelles, 벨기에, 1200
- Cliniques Universitaires Saint-Luc
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Namur
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Yvoir, Namur, 벨기에, 5530
- Cliniques Universitaires Mont-Godinne
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation.
- Recurrence must be confirmed by anatomopathology (cytology or biopsy)
- At least one measurable lesion by MRI or CT-scan.
- Failed or relapsing after first line chemotherapy including a platinum* or a taxane-based chemotherapy regimen
- Patients ineligible for chemotherapy could be included in first line
- ECOG performance status 0 -2, in stable medical condition
- Patients must have an expected survival of at least 3 months.
- Paraffin-embedded tumor tissue available for immunohistochemistry
- Patients must be over 18 years old and must be able to give written informed consent
- Women of child-bearing age or sexually active female patients with reproductive potential must have a negative pregnancy test (serum or urine within the 7 days prior to enrollment).
- Patients must have adequate organ function (Hemoglobin ≥ 8 g/100 ml, Neutrophils ≥ 1,000/mm3, Platelets ≥ 75,000/mm3, total bilirubin <1.5 times the upper limit of normal (ULN) for age (except for Gilbert's syndrome patients), serum alanine aminotransferase (ALT) <2.5 ´ ULN for age, aspartate aminotransferase (AST) <2.5 ´ ULN for age , serum creatinine £1.5 x ULN for age
- Acceptance of giving 20 ml of blood for eventual research at baseline
- Acceptance of giving two plasma samples (3ml) at baseline and after 3 weeks of treatment
- Signed informed consent prior to beginning protocol specific procedure
- Sexually active patients must use effective contraception during the period of therapy and up to 150 days after the last dose of CP-751,871. Acceptable contraception includes, but is not limited to: oral hormone therapy, partner vasectomy, or double barrier contraception (which is defined as a male condom plus spermicide in combination with either a female condom, or diaphragm, or cervical cap or intrauterine device).
Exclusion Criteria:
- Non-squamous head and neck cancer
- Nasopharynx cancer
- Brain metastases
- More than two lines of chemotherapy for palliative treatment (except if chemotherapy was given as a part of a multimodal treatment given with a curative intent)
- Surgery or irradiation or investigational drugs within 4 weeks before study inclusion
- Significant active cardiac disease including: uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias
- Subjects who are receiving chronic high dose immunosuppressive steroid therapy within 2 weeks prior to enrollment (³100 mg prednisone per day or >40 mg dexamethasone per day).
- Other uncontrolled illnesses (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes …)
- Previous malignancy, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- Other concomitant anticancer therapies.
- Previous treatment with anti-EGFR therapy is not an exclusion criteria.
- Prior anti-IGF-1R therapy
- Organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up.
공부 계획
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: 1
CP-751,871 will be administered as an open-label intravenous solution.
Patients will remain under clinical observation for one hour post-infusion
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20mg/kg/3 weeks
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Determine the efficacy of CP-751,871 alone in patients with head and neck cancer in term of overall response rate and stable disease (RECIST)
기간: 8 weeks
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8 weeks
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2차 결과 측정
결과 측정 |
기간 |
---|---|
To Determine the safety profile of CP-751,871 alone in patients with head and neck cancer. To Determine the efficacy of CP-751,871 alone in patients with head and neck cancer: progression-free survival and survival
기간: 8 weeks
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8 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jean-Pascal Machiels, MDPhD, Cliniques Universitaires Saint-Luc-UCL
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- GORTEC 2008/02
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. .
CP-751,871에 대한 임상 시험
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Pfizer완전한종양의 유잉 육종 계열스페인, 프랑스, 미국, 이탈리아, 호주, 독일, 영국, 이스라엘, 캐나다, 브라질, 칠레
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Pfizer종료됨
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Pfizer종료됨암종, 비소세포폐 | 암종, 편평 세포 | 암종, 대세포 | 암종, 선편평 세포미국, 불가리아, 이탈리아, 스페인, 우크라이나, 벨기에, 프랑스, 아일랜드, 대한민국, 폴란드, 러시아 연방, 영국, 헝가리, 세르비아, 대만, 캐나다, 남아프리카, 브라질, 루마니아, 그리스, 푸에르토 리코, 체코 공화국, 슬로베니아, 라트비아, 칠레, 인도네시아, 스위스
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Suzanne George, MDNovartis; Pfizer; Brigham and Women's Hospital완전한
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Pfizer종료됨암종, 비소세포폐 | 암종, 편평 세포 | 암종, 선편평 | 암종, 대세포미국, 불가리아, 캐나다, 우크라이나, 그리스, 오스트리아, 프랑스, 대한민국, 폴란드, 러시아 연방, 스페인, 칠면조, 핀란드, 헝가리, 대만, 이탈리아, 일본, 호주, 독일, 브라질, 인도, 푸에르토 리코, 체코 공화국, 슬로바키아, 홍콩, 스위스