- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01510119
Autophagy Inhibition to Augment Mammilian Target of Rapamycin (mTOR) Inhibition: A Phase I/II Trial of RAD001 and Hydroxychloroquine (HCQ) in Patients With Previously Treated Renal Cell Carcinoma
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
-
-
New Jersey
-
New Brunswick, New Jersey, 미국
- University of Medicine and Dentistry of New Jersey
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19104
- Abramson Cancer Center of the University of Pennsylvania
-
Pittsburgh, Pennsylvania, 미국
- University of Pittsburgh, Hillman Cancer Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 1 Histological evidence of metastatic renal cell carcinoma that has been previously treated with 1-3 prior regimens
- 2 Phase I only, any number of prior regimens with evidence of progressive disease
- 3 Patients must have at least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation
- 4 Age 18 years
- 5 Eastern Cooperative Oncology Group (ECOG) performance status £
- 6 Adequate bone marrow function as shown by: absolute neutrophil count (ANC) 1.5 x 109/L, Platelets 100 x 109/L, Hb 9 g/dL
- 7 Adequate liver function as shown by:
- 8 Serum bilirubin 1.5 x upper limit of normal
- 9 ALT and aspartate aminotransferase (AST) 2.5x upper limit of normal ( 5x upper limit of normal in patients with liver metastases)
- 10 international normalized ratio (INR) and PTT 1.5. (Anticoagulation is allowed if target INR 1.5 on a stable dose of warfarin or on a stable dose of anticoagulant for 2 weeks at time of randomization.) Adequate renal function: serum creatinine 2.0 x upper limit of normal or Creatinine Clearance 60 .11 Fasting serum cholesterol 300 mg/dL OR 7.75 mmol/L AND fasting triglycerides 2.5 x upper limit of normal . NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
- 12 Signed informed consent
Exclusion Criteria:
.1. Patients currently receiving anticancer therapy or who have received anticancer therapy within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.). To prevent explosive disease progression associated with angiogenic rebound from impacting the results of this study, patients who have received prior antiangiogenic therapy in the form of a small molecule multikinase inhibitor or bevacizumab must be off prior therapy for 1 week and have antiangiogenic therapy-associated adverse events (AEs) resolve to grade 2 before starting study treatment.
- 2 Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the course of the study
- 3 Prior treatment with any investigational drug within the preceding 4 weeks .4 Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
- 5 Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
- 6 Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
- 7 Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin, Stage I resected melanoma, ductal carcinoma in situ, squamous cell carcinoma of the skin, resected, basal cell carcinoma, indolent prostate cancer
- 8 Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
- 9 Symptomatic congestive heart failure of New York heart Association Class III or IV
- 10 Unstable angina pectoris, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
- 11 Severely impaired lung function with a previously documented spirometry and diffusing capacity of lung for carbon monoxide that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air
- 12 Uncontrolled diabetes as defined by fasting serum glucose 1.5 x ULN
- 13 Active (acute or chronic) or uncontrolled severe infections
- 14 Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- 15 A known history of HIV seropositivity as reported by the patient
- 16 Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
- 17 Patients with an active, bleeding diathesis
- 18 Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001)
- 19 Patients who have received prior treatment with an mammilian target of rapamycin (mTOR) inhibitor (sirolimus, temsirolimus, everolimus).(Phase I prior mTOR inhibitor allowed)
- 20 Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients
- 21 History of noncompliance to medical regimens
- 22 Patients unwilling to or unable to comply with the protocol .23 A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA polymerase chain reaction testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.
공부 계획
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 |
---|---|
실험적: Intervention - Dose Level 1
RAD001 given 10mg/daily by mouth and 400mg hydroxychloroquine twice daily by mouth.
Cycle 1 will include 1 week run-in of RAD001.
Following this, both RAD001 and hydroxychloroquine given without interruption.
Cycle 1 duration is 35 days; all subsequent cycles are 28 days.
RAD001 and hydroxychloroquine continuously administered until progression of disease or unacceptable toxicity.
|
다른 이름들:
다른 이름들:
|
실험적: Intervention - Dose Level 2 Phase 2
RAD001 given 10mg/daily by mouth and 600mg hydroxychloroquine twice daily by mouth.
Cycle 1 will include 1 week run-in of RAD001.
Following this, both RAD001 and hydroxychloroquine given without interruption.
Cycle 1 duration is 35 days; all subsequent cycles are 28 days.
RAD001 and hydroxychloroquine continuously administered until progression of disease or unacceptable toxicity.
|
다른 이름들:
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
PFS
기간: 6 개월
|
6 개월
|
공동 작업자 및 조사자
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 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. .
하이드록시클로로퀸에 대한 임상 시험
-
Government of Punjab, Specialized Healthcare and...Services Hospital, Lahore; Mayo Hospital Lahore; Pakistan Kidney and Liver Institute종료됨
-
Government of Punjab, Specialized Healthcare and...Harvard School of Public Health (HSPH); Forman Christian College, Pakistan; Services Institute... 그리고 다른 협력자들종료됨코로나바이러스감염증-19 : 코로나19 | 코로나바이러스 감염 | 사스 코로나바이러스 2 | 무증상 상태파키스탄
-
First Affiliated Hospital of Harbin Medical University알려지지 않은
-
Tan Tock Seng HospitalNetherlands: Ministry of Health, Welfare and Sports; Duke-NUS Graduate Medical School; Singapore... 그리고 다른 협력자들빼는코로나바이러스 감염 | 하이드록시클로로퀸 부작용
-
Hospital do CoracaoHospital Israelita Albert Einstein; Hospital Sirio-Libanes; Brazilian Research In Intensive... 그리고 다른 협력자들완전한
-
Second Affiliated Hospital, School of Medicine,...모병
-
Shanghai First Maternity and Infant HospitalFudan University; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Zhejiang... 그리고 다른 협력자들아직 모집하지 않음
-
First Affiliated Hospital Xi'an Jiaotong University완전한