- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00874107
Efficacy/Safety of Imprime PGG® Injection With Bevacizumab and Paclitaxel/Carboplatin in Patients With Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 2, Randomized, Efficacy and Safety Study of Imprime PGG® Injection in Combination With Bevacizumab and Concomitant Paclitaxel and Carboplatin Therapy in Patients With Previously Untreated Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Halle/Saale, 독일
- Hospital Marth-Maria Halle Dolau
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Kassel, 독일
- Clinical Kassel GmbH
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Köln, 독일
- Kliniken der Stadt Koln gGmbH
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Mainz, 독일
- University of Mainz
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Munich, 독일
- University of Munich
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Oldenburg, 독일
- Pius-Hospital Oldenburg
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Ulm, 독일, 89081
- Universitätsklinikum Ulm
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Arkansas
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Fayetteville, Arkansas, 미국, 72703
- Highlands Oncology Group
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Ohio
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Canton, Ohio, 미국, 44718
- Gabrail Cancer Center
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Texas
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San Antonio, Texas, 미국, 78229
- University of Texas Health Science Center, San Antonio
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC);
- Is between the ages of 18 and 75 years old, inclusive;
- Has histologically or cytologically confirmed stage IIIB (malignant pericardial or pleural effusion) or stage IV non-small cell lung cancer;
- Has non-squamous, non-small cell lung cancer
- Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST;
- Has an ECOG performance status of 0 or 1;
- Has a life expectancy of > 3 months;
Has adequate hematologic function as evidenced by:
- ANC ≥ 1,500/μL
- PLT ≥ 100,000/μL
- HGB ≥ 9 g/dL obtained within 1 week prior to the first dose of study medication;
Has adequate renal function as evidenced by:
- Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) for the reference lab
- Urine dipstick for proteinuria of < 1+ (i.e., either 0 or trace) within 2 weeks of Day 1 If urine dipstick is ≥ 1+, then urine protein excretion must be ≤ 500 mg over a 24 hour collection obtained within 1 week prior to the first dose of study medication;
Has adequate hepatic function as evidenced by:
- Serum total bilirubin ≤ 1.0 mg/dL
- AST ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases)
- ALT ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases) obtained within 1 week prior to the first dose of study medication;
Has adequate coagulation function as evidenced by:
- INR ≤ 1.5
- PTT ≤ ULN for the reference lab obtained within 1 week prior to the first dose of study medication;
- If a woman of childbearing potential or a fertile man (and his partners), must agree to use an effective form of contraception (hormonal contraceptive, double-barrier method or abstinence) during the study.
Exclusion Criteria:
- Has received prior systemic chemotherapy at any time for lung cancer;
- Has received previous radiation therapy to >30% of active bone marrow or any radiation therapy within 3 weeks of Day 1;
- Has a known hypersensitivity to baker's yeast, or has an active yeast infection;
- Has had previous exposure to Betafectin® or Imprime PGG;
- Has an active infection;
Presents with any of the following medical diagnoses/conditions at the time of screening:
- Central nervous system (CNS) metastases
- Uncontrolled hypertension (>150/100 mmHg) or hypertension that requires > two agents for adequate control
- Peripheral neuropathy ≥ grade 2 from any cause
- Fever of >38.5° C within 3 days prior to screening or Day 1, initial dosing
- Known HIV/AIDs, Hepatitis B, Hepatitis C, connective tissue or autoimmune disease, or other clinical diagnosis, ongoing or intercurrent illness that in the physician's opinion could interfere with participation
Has a history of any of the following medical diagnoses/conditions:
- Arterial or venous thromboembolic or hemorrhagic disorders including stroke, transient ischemic attack or cerebral infarction
- Deep vein thrombosis within 1 year prior to screening
- Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure) within the previous 6 months
- Second malignancy within the previous 5 years, other than basal cell carcinoma, cervical intra-epithelial neoplasia or curatively treated prostate cancer with a PSA of <2.0 ng/mL
- Has a known hypersensitivity to bevacizumab, murine proteins, or any component of bevacizumab;
- Has a know sensitivity to polyethoxylated castor oil;
- Has previously received treatment with bevacizumab;
- Has had surgery within 4 weeks of Day 1 or needle or open biopsy within 1 week of Day 1;
- Has a non-healing wound or gastric ulcer;
- Has a non-healed bone fracture;
- Is receiving systemic anti-coagulation therapy (e.g., dipyridalmole (Persantine®), ticlopidine (Ticlid®), clopidogrel (Plavix®) and /or cilostazol (Pletal®);
- Is receiving chronic daily treatment with aspirin (>100 mg/day) or other nonsteroidal anti-inflammatory agents known to inhibit platelet function within 1 week of Day 1;
Presents with any of the following medical diagnoses/conditions at the time of screening:
a. Predominant squamous cell histology
Has a history of any of the following medical diagnoses/conditions:
- Hemoptysis (≥ ½ tsp red blood)
- Bleeding diathesis or coagulopathy
- If female, is pregnant or breast-feeding;
- Is receiving concurrent investigational therapy or has received investigational therapy within a period of 30 days prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory-authority-approved indication);
- Has previously received an organ or progenitor/stem cell transplant.
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: 1
Imprime PGG + bevacizumab + paclitaxel/carboplatin
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4 mg/kg, i.v. over 2 hr, weekly until progression or discontinuation
15 mg/kg, i.v., over 90 minutes, on Day 1 only of each 3-week treatment cycle
200 mg/m2, i.v. over 3 hr, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.
AUC of 6 mg./mL · min based on the Calvert formula; i.v. over 30 min, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
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다른: 2
bevacizumab + paclitaxel/carboplatin
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15 mg/kg, i.v., over 90 minutes, on Day 1 only of each 3-week treatment cycle
200 mg/m2, i.v. over 3 hr, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.
AUC of 6 mg./mL · min based on the Calvert formula; i.v. over 30 min, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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To determine the objective response rate (ORR) in each study arm
기간: Approximately 1.5 years
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Approximately 1.5 years
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2차 결과 측정
결과 측정 |
기간 |
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To determine the disease control rate (DCR) in each study arm
기간: Approximately 1.5 years
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Approximately 1.5 years
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To determine the complete response (CR), partial response (PR), and stable disease (SD) rates in each study arm
기간: Approximately 1.5 years
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Approximately 1.5 years
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To determine the duration of objective tumor response in each study arm
기간: Approximately 1.5 years
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Approximately 1.5 years
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To determine the duration of stable disease in each study arm
기간: Approximately 1.5 years
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Approximately 1.5 years
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To determine the duration of time to progression (TTP) in each study arm
기간: Approximately 1.5 years
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Approximately 1.5 years
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To assess the safety of the dosing regimen within each study arm
기간: Approximately 1.5 years
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Approximately 1.5 years
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To determine the pharmacokinetic (PK) profile of Imprime PGG (in active treatment arm only)
기간: Approximately 1.5 years
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Approximately 1.5 years
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Folker Schneller, MD, Klinikum Rechts der Isar der Technischen Universitaet Muenchen
간행물 및 유용한 링크
일반 간행물
- Salvador C, Li B, Hansen R, Cramer DE, Kong M, Yan J. Yeast-derived beta-glucan augments the therapeutic efficacy mediated by anti-vascular endothelial growth factor monoclonal antibody in human carcinoma xenograft models. Clin Cancer Res. 2008 Feb 15;14(4):1239-47. doi: 10.1158/1078-0432.CCR-07-1669.
- Engel-Riedel W, Lowe J, Mattson P, Richard Trout J, Huhn RD, Gargano M, Patchen ML, Walsh R, Trinh MM, Dupuis M, Schneller F. A randomized, controlled trial evaluating the efficacy and safety of BTH1677 in combination with bevacizumab, carboplatin, and paclitaxel in first-line treatment of advanced non-small cell lung cancer. J Immunother Cancer. 2018 Feb 27;6(1):16. doi: 10.1186/s40425-018-0324-z.
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 (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. .
비소세포폐암에 대한 임상 시험
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Millennium Pharmaceuticals, Inc.완전한GCB(Non-Germinal B-cell-like) 미만성 거대 B-세포 림프종(DLBCL)미국
Imprime PGG® Injection에 대한 임상 시험
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HiberCell, Inc.완전한
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Shanghai University of Traditional Chinese Medicine알려지지 않은
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University of Illinois at ChicagoHiberCell, Inc.종료됨
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HiberCell, Inc.빼는
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Merck Sharp & Dohme LLC완전한화학요법 유발 메스꺼움 및 구토미국, 그리스, 헝가리, 리투아니아, 네덜란드, 페루, 폴란드, 러시아 연방, 영국
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Merck Sharp & Dohme LLC종료됨