- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00177281
Safety Study of S-CKD602 in Patients With Advanced Malignancies
A Phase I Study to Evaluate the Safety and Pharmacokinetics of S-CKD602 in Patients With Advanced Malignancies
연구 개요
상세 설명
The main purposes of this study are:
To determine the maximum tolerated dose (highest dose that can safely be given to subjects) of S CKD602 when given every three weeks.
To determine the incidence and severity of toxicity (side-effects) of S CKD602 when given every three weeks.
To determine a subject's body handles the drug (pharmacokinetics) following administration of S CKD602.
In addition to the above, we would also like to analyze how the genes (material inside each cell that is responsible for cell functioning and appearance) found in a subject's blood affect how the study drug S-CKD602 is broken down in a subject's body. This process is referred to as "metabolic genotyping analyses". This evaluation is performed using a blood sample and is optional.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15232
- University of Pittsburgh Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Male or female subjects with an age > 18 years Histologically or cytologically proven malignancy, unresponsive to curative surgery, radiotherapy, conventional chemotherapy or for which no conventional therapy exists. (Measurable or evaluable disease is desirable, but not required) Note: This study is restricted to patients with advanced solid tumors, subjects with hematological malignancies are excluded (including lymphoma and leukemia) ECOG Performance Status 0- 2 Adequate bone marrow function, without the support of cytokines and/or Epoetin Alpha within 5 days prior to dosing: Absolute neutrophil count (ANC) >1,500/mm3, platelet count > 100,000/mm3, Hgb > 9.0 g/dL. Adequate liver function: total bilirubin level < 2.0 mg/dL, ALT and AST < 2.0 x institutional upper limit of normal in the absence of liver metastasis, or < 4.0 x institutional upper limit of normal in the presence of liver metastasis.
Adequate renal function: serum creatinine < 1.5 mg/dL. At least 3 weeks since prior chemotherapy or cancer surgery (6 weeks for nitrosourea or mitomycin C).
Normal cardiac function with no history of uncontrolled heart disease. Women subjects (if of child bearing potential and sexually active) and male subjects (if sexually active with a partner of child bearing potential) must use medically acceptable methods of birth control prior to study entry and for the duration of the study. Medically acceptable methods of contraception that may be used by the subject and/or his/her partner include abstinence, birth control pills or patches, diaphragm and spermicide, IUD, condom and vaginal spermicide, surgical sterilization, post menopausal, vasectomy, and progestin implant or injection.
Written informed consent.
Exclusion Criteria:
Subject is pregnant or is breast feeding. Subject's life expectancy is less than 3 months. Subject exhibits confusion, disorientation, or has a history of major Psychiatric illness, which may potentially impair subject's understanding of the informed consent.
Subject has signs and symptoms of acute infection requiring systemic therapy. Subject has used another investigational agent within 30 days of dosing with S CKD602.
Subjects with known allergic reactions to camptothecin analogs, dextran sulfate or other components of S-CKD602 Symptomatic or uncontrolled brain leptomeningeal metastasis. CT scans are not required unless there is clinical suspicion of central nervous disease.
Not recovered from reversible toxicity of prior therapy. Subjects with known brain metastases because of their poor prognosis because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Concurrent radiation therapy or radiation within 3 weeks of starting treatment with S-CKD602.
Concurrent anti-neoplastic agents.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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To determine the maximum tolerated dose of S CKD602 when given every three weeks.
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To determine the incidence and severity of toxicity of S CKD602 when given every three weeks.
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2차 결과 측정
결과 측정 |
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To determine the pharmacokinetics of CKD 602 following administration of S CKD602.
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공동 작업자 및 조사자
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
- 03-052
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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Boston Scientific Corporation완전한