- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01886287
P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome
Phase II Study of Above-Label Octreotide-LAR in Patients With Insufficiently Controlled Carcinoid Syndrome
연구 개요
상세 설명
The study population will consist of patients with advanced (metastatic or unresectable) neuroendocrine tumors with suboptimally controlled carcinoid syndrome. While the majority of patients will have primary tumors of the ileocecum (midgut), any serotonin-producing neuroendocrine tumors will be eligible (including pancreatic, lung and unknown primary).
All patients will be followed for adverse events and serious adverse events for 28 days following the last dose of above-label octreotide, or until resolution or stabilization of the event, whichever comes first.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Florida
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Tampa, Florida, 미국, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Metastatic neuroendocrine tumors that are considered well or moderately differentiated (or low to intermediate grade). Patients with poorly differentiated neuroendocrine carcinomas or small cell carcinomas are excluded from the study.
- Elevated urine 5-hydroxyindoleacetic acid (5-HIAA)
- More than 2 bowel-movements per day OR more than 4 flushing episodes per week on average
- Patient currently on octreotide LAR 30mg every 3 or 4 weeks (for at least 3 cycles prior to screening)
- Age ≥ 18 years
- Minimum of four weeks since any major surgery, liver-directed therapy (embolization, etc.) or systemic cancer treatment other than octreotide LAR
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Life expectancy > 12 weeks
- Reliable contraception should be maintained throughout the study and for 3 months after study drug discontinuation.
- Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information.
Exclusion Criteria:
- Known hypersensitivity to somatostatin analogues
- Patients with poorly differentiated neuroendocrine cancers
- Patients with liver cirrhosis
- Patients receiving hemodialysis or peritoneal dialysis
- Patients with cachexia who, in the opinion of the investigator, may have difficulty tolerating intramuscular injection
- Patients with symptomatic cholelithiasis or biliary events within past five years (who have not undergone cholecystectomy)
- Patients with recent history (within 5 years) of pancreatitis
- Patients with uncontrolled diabetes (HgA1c >8.0 despite adequate therapy)
- Women of child-bearing potential, UNLESS they are using two birth control methods
- Women who are pregnant or lactating
- HIV positive patients
- History of sustained ventricular tachycardia, ventricular fibrillation, advanced heart block, idiopathic syncope thought to be related to ventricular arrhythmia, or congenital long QT syndrome
- Risk factors for Torsades de Pointes such as cardiac failure, clinically significant/symptomatic bradycardia
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- History of noncompliance to medical regimens or unwillingness to comply with the protocol
- Patients who were unable to tolerate or did not benefit from above-label dose octreotide (>30mg) in the past
- Concomitant use of other cancer treatments or carcinoid syndrome treatments (whether standard or experimental). Patients should discontinue any concomitant cancer medications more than two weeks prior to screening.
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 |
---|---|
실험적: Octreotide Long-acting Release (LAR)
Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
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Octreotide LAR as outlined in Treatment Arm.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of Participants With Improved Frequency of Diarrhea
기간: At 12 weeks
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The frequencies of flushing, diarrhea, and carcinoid syndrome control rating (scale 1-5) will be measured and compared at week 0 and week 12 .
These measurements will be compared using two-sided non-parametric paired Wilcoxon signed-rank.
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At 12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Rate of Progression Free Survival (PFS) at 6 Months
기간: At 6 months
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Progression-free survival, defined as rate of patients alive and free of progression from the date of first study treatment to the end of trial at 6 months.
Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
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At 6 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- MCC-17410
- CSMS995AUS64T (기타 식별자: Novartis)
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. .
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