- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00889382
A Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)
A Phase 1/2 Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Moscow, 러시아 연방, 129128
- Central Clinical Hospital
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Moscow, 러시아 연방, 143423
- Moscow City Oncology Hospital
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Obninsk, 러시아 연방, 249036
- State Institution Medical Radiology Scientific Center
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St. Petersburg, 러시아 연방, 198255
- Sity Clinical Oncology
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Cluj Napoca, 루마니아, 400015
- Institutul Oncologic Prof. Dr. Ion. Chiricuta Sectia de Oncologie Medicala
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Cluj Napoca, 루마니아, 400015
- Institutul Oncologic Prof. Dr. Ion. Chiricuta Sectia Radiologie
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Iasi, 루마니아, 700106
- Oncology Medical Centre SCM
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Mures, 루마니아, 540072
- Clinical Caunty Hospital Mures
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Arizona
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Scottsdale, Arizona, 미국, 85259
- Mayo Clinic
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California
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Orange, California, 미국, 92868
- Department of Obstetrics and Gynecology, University of California, Irvine
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Indiana
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Lafayette, Indiana, 미국, 47906
- Horizon Oncology Center
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Louisiana
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New Orleans, Louisiana, 미국, 70121
- Ochsner Clinic Foundation
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New Jersey
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Morristown, New Jersey, 미국, 07960
- Morristown Memorial Hospital
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North Carolina
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Charlotte, North Carolina, 미국, 28204
- Blumenthal Cancer Center - Main
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Durham, North Carolina, 미국, 27710
- Duke University Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- University of Oklahoma Health Sciences Center
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Bellinzona, 스위스, CH-6500
- Ospedale San Giovanni
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London, 영국, SW3 6JJ
- Royal Marsden Hospital
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London, 영국, WC1E 6BT
- University College Hospital
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Manchester, 영국, M20 4BX
- The Christie NHS Foundation Trust
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Northwood, 영국, HA62RN
- Mount Vernon Cancer Center
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Oxford, 영국, OX37LI
- Churchill Hospital
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Withington, 영국, M20 4BX
- Christie NHS Foundation Trust
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Surrey
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Sutton, Surrey, 영국, SM2 5PT
- Drug Development Unit Royal Mardsen NHS Foundation Trust
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Bologna, 이탈리아, 40138
- Universitaria di Bologna Policlinico
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Carpi, 이탈리아, 91012
- Ospedale di Carpi, AUSL di Modena
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Milan, 이탈리아, 20141
- Instituto Europeo di Oncologia
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Roma, 이탈리아, 67100
- Oncology IDI- IRCSS
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Kralove, 체코, 50005
- University Hospital Hradec Kralove
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Ostrava- Poruba, 체코, 70852
- University Hospital Ostrava
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Prague, 체코, 212000
- General University Hospital, Department of Obstetrics and Gynecology
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Ontario
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Hamilton, Ontario, 캐나다, L8V 5C2
- Juravinski Cancer Center
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Toronto, Ontario, 캐나다, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, 캐나다, H3T 1E2
- McGill University
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Lublin, 폴란드, 20-090
- III Oddzial Onkologii Ginekologicznej
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Poznan, 폴란드, 61 866
- Oddzial Radioterapii
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Poznan, 폴란드, 61-878
- Klinika Onkologii AM w Poznaniu
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New South Wales
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WestMead, New South Wales, 호주, 2145
- Westmead Hospital
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Queensland
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South Brisbane, Queensland, 호주, 4101
- Mater Adult Hospital
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South Australia
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North Terrace, South Australia, 호주, 5000
- Royal Adelaide Hospital
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Tasmania
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Launceston, Tasmania, 호주, 7250
- Launceston General Hospital
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Victoria
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Frankston, Victoria, 호주, 3199
- Frankston Hospital
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Wodonga, Victoria, 호주, 3690
- Border Medical Oncology
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Western Australia
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Bunbury, Western Australia, 호주, 6230
- St. John of God Hospital, Bunbury
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Perth, Western Australia, 호주, 6009
- Sir Charles Gairdner Hospital
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Subiaco, Western Australia, 호주, 6008
- St. John of Gog Hospital, Subiaco
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically or cytologically confirmed epithelial ovarian carcinoma Patients with fallopian or peritoneal cancer will also be eligible
- Patients with any solid tumor that may be treated with weekly paclitaxel will be eligible for the phase 1 portion
- For the phase 2 portion, patients must have elevated CA125 levels evaluable/assessable according to Gynecological Cancer Intergroup (GCIG) criteria (ie, > 70 U/mL) documented by 2 measurements at least 1 week apart
- Patients must have radiologically confirmed progressive disease by RECIST v1.1 criteria within 6 months prior to randomization. (patients must have measurable disease according to RECIST v1.1)
- Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 -1
- Predicted life expectancy ≥ 12 weeks
Patients may have had prior therapy, providing the following conditions are met:
Chemotherapy: Prior chemotherapy must have been completed at least 3 weeks prior to study enrollment (6 weeks for mitomycin C, nitrosoureas or high-dose carboplatin [≥ 600 mg/m²]and 4 weeks for investigational drugs
- Patient should have recovered from any drug-related toxicities (with the exception of grade 1 neuropathy and or alopecia)
- Phase 1: While there is no limit on the number of prior regimens for patients entered into the phase 1 portion, any prior taxane therapy must have been administered on a 3 week schedule
- Phase 2: Patients must have received prior chemotherapy, which must have contained a platinum and a taxanes at some point. Any prior taxanes therapy must have been administered on a 3 week schedule. A maximum of 2 prior chemotherapy regimens are permitted. Patients must be refractory radiologically confirmed by computerized tomography (CT) scan progressive disease (PD) during chemotherapy) or resistant (radiologically confirmed by CT scan PD within six months of completing chemotherapy) to their last platinum-containing chemotherapy regimen
Radiation: Patients may have had prior radiation therapy provided they have recovered from the acute, toxic effects of radiotherapy prior to registration/randomization. Radiated lesions cannot be chosen as the target lesions
a. A minimum of 21 days must have elapsed between the end of radiotherapy and registration/randomization into the study unless the radiation affected less than 25% of bone marrow
- Surgery: Previous surgery is permitted provided that adequate wound healing has occurred prior to registration/randomization
- Fasting glucose ≤ 150 mg/dL (8.3 mmol/L)
Adequate hematopoietic, hepatic, and renal function defined as follows:
- Neutrophil count ≥ 1.5 x 10 ^9 /L and platelet count > = 100 x 10^9/L;
- Bilirubin ≤ 1.5 x Upper Limit of Normal (ULN);
- AST and/or ALT ≤ 2.5 x ULN or < = 5 x ULN if patient has documented liver metastases; and
- Serum creatinine ≤ 1.5 x ULN
Female patient must be either:
Of non childbearing potential:
- post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
- documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening)
Or, if of childbearing potential:
- must have a negative urine pregnancy test at Screening, and
- must use two forms of birth control (one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days [or 5 half lives, whichever is longer] after final study drug administration
- Female patient must not be breastfeeding at Screening or during the study period and for 28 days [or 5 half lives of the study drug whichever is longer] after final study drug administration
- Female patient must not donate ova starting at Screening and throughout the study period and for 28 days [or 5 half lives of the study drug whichever is longer] after final study drug administration
- Patients must provide verbal and written informed consent to participate in the study
Exclusion Criteria:
- Diabetes mellitus currently requiring medication (eg, insulin or oral hypoglycemics)
- During the phase 2 portion, patients with histology of abdominal adenocarcinoma of unknown origin or a diagnosis of a borderline ovarian tumor
- Previous or concurrent malignancies (excluding curatively treated basal or squamous cell carcinoma of the skin or cervical carcinoma in situ) unless the patient has been in remission for at least 3 years
- History of significant cardiovascular disease unless the disease is well-controlled. Significant cardiac diseases includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea)
- History of cerebrovascular accident (CVA) within 6 months prior to registration/randomization or that is not stable
- Prior therapy with an insulin-like growth factor (IGF-1R) inhibitor
- Use of drugs that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing
- Known or prior hypersensitivity to taxanes in spite of premedication or drugs containing Cremophor
- Gastro-intestinal abnormalities, including bowel obstruction, inability to take oral medication, requirement for intravenous (IV) alimentation,active peptic ulcer or prior surgical procedures or bowel resection affecting absorption
- Active infection or serious underlying medical condition (including any type of active seizure disorder within 12 months prior to registration/randomization) that would impair the ability of the patient to receive protocol treatment
- History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
- Pregnancy or breast-feeding
- Symptomatic brain metastases that are not stable, require steroids, are potentially life threatening, or that have required radiation within 28 days prior to registration/randomization
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug
- History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (≥ grade 3), left bundle branch block (LBBB), or asymptomatic sustained ventricular tachycardia are not allowed. Patients with atrial fibrillation controlled by medication are not excluded. Patients with mean QTcF interval ≥ 450 msec at screening are excluded
- Use of drugs that have a known risk of causing Torsade de Pointes (TdP) or that that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing are prohibited
- Use of the potent CYP1A2 inhibitors ciprofloxacin and fluvoxamine. Other less potent CYP1A2 inhibitors/inducers are not excluded
- Participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives whichever is longer, prior to the initiation of Screening or during the course of the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Phase 1 Arm A
Intermittent OSI-906 Once Daily (QD) on Days 1 - 3, 8 - 10, and 15 - 17 with paclitaxel on Days 1, 8, and 15 (except Treatment Period 1 (TP 1); in TP 1 OSI-906 on Days 1 - 3, 8 - 10, 15 - 17, and 22 - 24 with paclitaxel on Days 8, 15, and 22)
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정맥 투여
구두로 관리
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실험적: Phase 1 Arm B1
Continuous OSI-906 Twice Daily (BID) (Days 1 - 21) with paclitaxel dosing on Days 1, 8, and 15;(except TP 1; in TP 1 OSI-906 on Days 1 - 3, 8 - 10, 15 - 17, and 22 - 24 with paclitaxel on Days 8, 15 and 22)
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정맥 투여
구두로 관리
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실험적: Phase 1 Arm B2
Continuous OSI-906 BID (Days 1 - 21) with paclitaxel dosing on Days 1, 8, and 15 (except TP 1; in TP 1 OSI-906 on Days 1 - 3, 8 - 10, 5 - 17, and 22 - 24 with paclitaxel on Days 8, 15, and 22); (additional PK sampling on Days 9 or 13 0r 14 for TP 1)
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정맥 투여
구두로 관리
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실험적: Phase 1 Arm B3
Continuous OSI-906 BID (Days 1 - 21) with paclitaxel dosing on Days 1, 8, and 15 with no separation in OSI-906 and paclitaxel dosing (except TP 1; in TP 1 continuous OSI-906 dosing 2 hours prior to the initiation of paclitaxel infusion on Day 8 only, with paclitaxel on Days 8, 15, and 22, and additional PK sampling on Day 9 or 13 or 14)
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정맥 투여
구두로 관리
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실험적: Phase 2 Arm A
Intermittent OSI-906 QD on Days 1 - 3, 8 - 10, and 15 - 17 with paclitaxel on Days 1, 8, and 15
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정맥 투여
구두로 관리
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실험적: Phase 2 Arm B
Continuous OSI-906 BID from Day 1 onwards with paclitaxel on Days 1, 8, and 15
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정맥 투여
구두로 관리
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실험적: Phase 2 Arm C
Paclitaxel on Days 1, 8, and 15
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정맥 투여
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실험적: Phase 2 Arm C Roll-over
Continuous OSI-906 BID from Day 1 onwards
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구두로 관리
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Determine Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
기간: 28 days
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Primary outcome measure for Phase 1 portion
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28 days
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Progression Free Survival (PFS)
기간: 36 months
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Primary outcome measure for the Phase 2 portion; The time from the date of randomization until date of radiographic disease progression per RECIST v1.1 or until death due to any cause
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36 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Objective Response Rate (ORR)
기간: 36 months
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The proportion of patients with a confirmed response of Complete Response (CR) or Partial Response (PR) per RECEIST v1.1
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36 months
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Cancer Antigen 125 (CA125) Response Rate
기간: 36 months
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Response Rate is defined as at least 50% reduction in serum CA-125 levels from pretreatment levels; Response rate is the proportion of patients with a CA-125 response among evaluable patients
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36 months
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Duration of Response (DOR)
기간: 36 months
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The time from the date of the first documented radiographic response (CR/PR) to first documented radiographic progression or death due to underlying cancer
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36 months
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Duration of CA-125 Response (CA-125 DOR)
기간: 36 months
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The time from the date of the first documented CA-125 response to the date of CA-125 progression
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36 months
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Overall Survival (OS)
기간: 36 months
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The time from the date of randomization until the documented date of death
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36 months
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Safety assessed via physician exam, vital signs, clinical laboratory tests, electrocardiograms (ECG), and adverse events
기간: 36 months
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36 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Principal Investigator - Czech Republic, General Faculty Hospital, Charles University
- 수석 연구원: Principal Investigator - Italy, Instituto Europeo de Oncologia
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- OSI-906-202
- 2009-010319-34 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구 프로토콜
- 통계 분석 계획(SAP)
- 임상 연구 보고서(CSR)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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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