Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors
2015년 1월 15일 업데이트: Pfizer
A Phase 1, Multicenter, Open-label, Dose-escalation, Safety, Pharmacokinetic, And Pharmacodynamic Trial Of Cvx-060, A Selective Angiopoietin-2 (Ang-2) Binding, Anti-angiogenic Covx-body, In Patients With Advanced Solid Tumors
The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.
연구 개요
연구 유형
중재적
등록 (실제)
34
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Arizona
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Scottsdale, Arizona, 미국, 85258
- Premiere Oncology of Arizona
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Scottsdale, Arizona, 미국, 85255
- Scottsdale Medical Imaging, Ltd.
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California
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Santa Monica,, California, 미국, 90404
- Premiere Oncology, A Medical Corporation
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19111
- Fox Chase Cancer Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Confirmed advanced solid tumors unresponsive to currently available therapies or for which there is no standard therapy.
- Adequate coagulation, liver, and renal function.
- Candidate for DCE-MRI evaluations.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
Exclusion Criteria:
- Evidence of significant bleeding problems.
- History of certain gastrointestinal problems including fistula and abscess.
- Chronic, uncontrolled hypertension.
- Patients with any history of primary or metastatic tumor involvement of the brain or with tumors that encase great vessels.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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 |
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실험적: 1
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Weekly, intravenous dose
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
기간: Baseline (Day 0) up to 30 days after last dose of study medication
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Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Relatedness to CVX-060 was assessed by the investigator (Yes/No).
Participants with multiple occurrences of an AE within a category were counted once within the category.
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Baseline (Day 0) up to 30 days after last dose of study medication
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Maximum Observed Serum Concentration (Cmax)
기간: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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Serum Decay Half-Life (t1/2)
기간: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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Serum decay half-life is the time measured for the serum concentration to decrease by one half.
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0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)]
기간: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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AUC (0-168)= Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours after dosing (Day 7).
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0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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Apparent Volume of Distribution (Vss)
기간: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after intravenous infusion dose (Vss) is influenced by the fraction absorbed.
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0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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Apparent Clearance (CL)
기간: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes).
Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.
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0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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Time to Reach Maximum Observed Serum Concentration (Tmax)
기간: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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Recommended Phase 2 Dose (RP2D): Stage 1
기간: Baseline (Day 0) up to 42 days after the last dose of study medication
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RP2D was determined as the highest dose where none out of 3 (0/3) or less than or equal to 1 out of 6 (<=1/6) participants experienced a dose limiting toxicity (DLT) or was determined based on the safety, pharmacokinetic, and pharmacodynamic findings.
DLT was first course AE defined based on National Cancer Institute common toxicity criteria for adverse events version 3 (NCI-CTCAE Version 3) as any hematologic or non-hematologic toxicity greater than or equal to (>=) Grade 3.
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Baseline (Day 0) up to 42 days after the last dose of study medication
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Number of Participants With Anti-CVX-060 Antibodies
기간: Baseline (Day 0) up to 42 days after last dose
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Baseline (Day 0) up to 42 days after last dose
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Number of Samples From Participants With Anti-CVX-060 Antibodies
기간: Baseline (Day 0) up to 42 days after last dose
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Baseline (Day 0) up to 42 days after last dose
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Number of Participants With Best Overall Response (BOR)
기간: Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)
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BOR: best response recorded from treatment start until disease progression/recurrence based on Response Evaluation Criteria in Solid Tumors (RECIST).
Complete Response (CR): disappearance of all lesions.
Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions taking as reference baseline SLDs, associated to non-progressive disease (non-PD) response for non-target (NT) lesions.
PD: >=20% increase in SLDs of target lesions taking as reference smallest SLDs since treatment start, or appearance of >=1 new lesion, or unequivocal progression in NT lesions.
Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest SLDs since treatment start.
CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after initial objective documentation of response.
SD criteria should be met at least once after start of treatment in a minimum interval of 8 weeks.
Participants with >=3 treatments cycles were reported.
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Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 1월 1일
기본 완료 (실제)
2011년 4월 1일
연구 완료 (실제)
2011년 4월 1일
연구 등록 날짜
최초 제출
2009년 4월 9일
QC 기준을 충족하는 최초 제출
2009년 4월 9일
처음 게시됨 (추정)
2009년 4월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 1월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 1월 15일
마지막으로 확인됨
2015년 1월 1일
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. .
CVX-060에 대한 임상 시험
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Pfizer완전한
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The University of Texas Health Science Center at...National Cancer Institute (NCI); Cancer Therapy and Research Center, Texas완전한