- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00457743
A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)
A Phase I/II Study of Sunitinib Malate (SU011248) In The Treatment of Patients With Malignant Gastrointestinal Stromal Tumor (GIST) Previously Treated by Imatinib Mesylate.
Phase I;To investigate the clinically recommended dose of Sunitinib malate (SU011248) following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by reviewing the safety and tolerability.
Phase II;To determine the objective tumor response and the safety of Sunitinib malate (SU011248) at the clinically recommended dose.
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Chiba
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Kashiwa, Chiba, 일본
- Pfizer Investigational Site
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Hokkaido
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Sapporo, Hokkaido, 일본
- Pfizer Investigational Site
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Osaka
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Suita, Osaka, 일본
- Pfizer Investigational Site
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Tokyo
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Chuo-ku, Tokyo, 일본
- Pfizer Investigational Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with histologically-confirmed metastatic or unresectable gastrointestinal stromal tumor (GIST).
- Patients previously treated with imatinib mesylate.
Exclusion Criteria:
- Patients who have not recovered from the acute toxic effects of previous antineoplastic therapy or treatment with imatinib mesylate.
- Any tumor therapy for gastrointestinal stromal tumor (GIST) discontinued less than 4 weeks prior to starting study treatment. Imatinib mesylate discontinued less than 2 weeks prior to starting therapy.
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 |
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실험적: SU011248
25 , 50 or 75 mg/day of SU011248
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SU011248
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of Subjects With Dose Limiting Toxicities (DLT)
기간: Cycle 1 (Baseline to Week 6)
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Dose Limiting Toxicities(DLT) in the subjects enrolled in Phase 1.
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Cycle 1 (Baseline to Week 6)
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Maximum Plasma Concentration (Cmax) on Cycle 1 Day 1
기간: Day 1 of Cycle 1
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Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662). |
Day 1 of Cycle 1
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Maximum Plasma Concentration (Cmax) on Cycle 1 Day 28
기간: Day 28 of Cycle 1
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Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662). |
Day 28 of Cycle 1
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Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 1
기간: Day 1 of Cycle 1
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Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662). |
Day 1 of Cycle 1
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Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 28
기간: Day 28 of Cycle 1
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Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662). |
Day 28 of Cycle 1
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Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 1
기간: Day 1 of Cycle 1
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Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of median of Tmax of SU-011248 and SU-012662). |
Day 1 of Cycle 1
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Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 28
기간: Day 28 of Cycle 1
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Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of medians of Tmax of SU-011248 and SU-012662). |
Day 28 of Cycle 1
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SU-011248 Clearance on Cycle 1 Day 28
기간: Day 28 of Cycle 1
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SU-011248 Clearance in the subjects enrolled in Phase 1. Clearance was calculated by dividing a SU-011248 dose(mg) by AUC0-24(ng•h/mL). |
Day 28 of Cycle 1
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Accumulation Ratio (Rac) on Cycle 1 Day 28
기간: Day 28 of Cycle 1
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Accumulation Ratio (Rac) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) on Cycle 1 Day 28 in the subjects enrolled in Phase 1. Rac was the ratio of Day 28 to Day 1. |
Day 28 of Cycle 1
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Number of Subjects With Clinical Benefit Response (CBR) Based on the Extramural Review Committee Assessment in Recommended Dose Group
기간: Day 28 of Cycles 1-4
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Clinical Benefit Response is defined as sum of subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).
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Day 28 of Cycles 1-4
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)
기간: Day 1, 14, 28 of Cycles 1-4
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Plasma concentrations of potential pharmacodynamic markers; Vascular Endothelial Growth Factor (VEGF)
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Day 1, 14, 28 of Cycles 1-4
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Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
기간: Day 1, 14, 28 of Cycles 1-4
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Plasma concentrations of potential pharmacodynamic markers; Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
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Day 1, 14, 28 of Cycles 1-4
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Plasma Concentrations of Soluble Stem Cell Factor Receptor (sKIT)
기간: Day 1, 14, 28 of Cycles 1-4
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Plasma concentrations of potential pharmacodynamic markers; Soluble Stem Cell Factor Receptor (sKIT)
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Day 1, 14, 28 of Cycles 1-4
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Trough Plasma Concentration (Ctrough) of SU-011248
기간: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
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Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration
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Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
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Trough Plasma Concentration (Ctrough) of SU-012262
기간: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
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Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration
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Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
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Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662
기간: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
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Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration
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Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
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Changes From Baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaires
기간: Day 7, 14, 28, 35 of Cycle 1; Day 1, 7, 14, 28, 35 of Cycles 2-4
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Patient-reported outcome: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaires (version 4A). The questionnaire consists of a 13-item subscale which covers specific fatigue questions. The subject rates the intensity of fatigue and its related symptoms on a five-point scale(0 to 4). High score is indicating low fatigue. The total score of the 13 items was evaluated. Change from Baseline: Score at each observation minus score at baseline |
Day 7, 14, 28, 35 of Cycle 1; Day 1, 7, 14, 28, 35 of Cycles 2-4
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Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires
기간: Day 28 of Cycle 1; Day 1, 28 of Cycles 2-4
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The EQ-5D questionnaires evaluates 5 dimensions of health. The subjects rates the severity of impairment for each dimensions on a 3-point scale(1 to 3). The digits for five dimensions were combined in a five-digit number describing the respondent's health state. Health states were converted into a weighted health state index. High score is indicating high health. Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline |
Day 28 of Cycle 1; Day 1, 28 of Cycles 2-4
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Number of Subjects With Disease Controlled Based on the Extramural Review Committee Assessment in Recommended Dose Group
기간: Day 28 of Cycles 1-4
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Number of subjects with Disease Controlled is defined as sum of the subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 10 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).
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Day 28 of Cycles 1-4
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Number of Subjects With Objective Response Based on the Extramural Review Committee Assessment in Recommended Dose Group
기간: Day 28 of Cycles 1-4
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Number of subjects with Objective Response is defined as sum of the subjects confirmed with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
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Day 28 of Cycles 1-4
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Time To Tumor Progression (TTP)
기간: From the first dose to Progressive Disease
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Time To tumor Progression (TTP) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD).
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From the first dose to Progressive Disease
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Progression-Free Survival (PFS)
기간: From the first dose to Progressive Disease or Death
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Progression-Free Survival (PFS) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD) or death.
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From the first dose to Progressive Disease or Death
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Time To Failure (TTF)
기간: From the first dose to Progressive Disease, Treatment discontinuation except completion of treatment, or Death due to cancer.
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Time To Failure (TTF) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD), the date of treatment discontinuation except completion of treatment, or date of death due to cancer.
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From the first dose to Progressive Disease, Treatment discontinuation except completion of treatment, or Death due to cancer.
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Overall Survival Time
기간: From the first dose to death
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Overall Survival Time is defined as the time from the date of first dose of study treatment to the date of the death due to any cause. For subjects whose death had not been confirmed, Overall Survival Time was censored on the last date when the patient was known to be alive. Survival was surveyed once a year from the registration day of the first subject, for all the subjects who received the study drug at least once. |
From the first dose to death
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공동 작업자 및 조사자
스폰서
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- A6181045
- JapicCTI-070386
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. .
Sunitinib malate (SU011248)에 대한 임상 시험
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.완전한
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H. Lee Moffitt Cancer Center and Research InstitutePfizer완전한
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)종료됨상세불명의 성인 고형 종양, 프로토콜 특정 | 전이성 암 | 인지/기능적 효과미국
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ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)완전한