- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00987584
Phase II Cont. IV of ON 01910.Na in MDS w/ Trisomy 8/Intermed-1, 2/High Risk
A Biologic Correlates Study for "A Phase 2 Single-Arm Study To Assess The Efficacy and Safety Of 48-Hour Continuous Intravenous Dosing Of ON 01910.Na Administered Once a Week for 3 Weeks of a 4-Week Cycle in Myelodysplastic Syndrome Patients With Trisomy 8 or Classified as Intermediate-2 or High Ris
This study is under Molecular and Cellular Characterization of Myelodysplastic Syndromes (MDS) (eProtocol 15369). The purpose of this proposed study is to analyze existing samples taken from participants participating in a clinical trial evaluating the efficacy and safety of investigational agent ON 01910.Na (eProtocol 16214). This study will use existing blood and marrow samples to determine the rate and duration of objective hematologic and marrow responses, and duration of progression-free survival in ON01910.Na-treated MDS patients.
This study will use existing blood and marrow samples to determine the rate and duration of objective hematologic and marrow responses, and duration of progression-free survival in ON01910.Na-treated MDS patients.
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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California
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Stanford, California, 미국, 94305
- Stanford University School of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Diagnosis of IPSS Intermediate or High risk MDS by bone marrow biopsy, marrow cytogenetics and blood counts, using FAB morphologic criteria
- Eastern Cooperative Oncology (ECOG) performance status of 0-2
- Adequate Liver Function, as evidenced by a serum bilirubin less or equal to 1.5 times the laboratory normal range (except for patients with a confirmed diagnosis of Gilberts Disease) or an ALT and AST 3 times the laboratory normal range
- A serum creatinine concentration less or equal to 2mg/dl
- Subjects must be equal or greater than 18 years of age at the time of obtaining informed consent
- Written informed consent
Exclusion Criteria:
- Prior history of leukemia or aplastic anemia
- Prior history of bone marrow transplantation
Platelet count <100,000/mm^3
*Prior malignancy (other than in situ cervical cancer, controlled prostate cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for greater or equal to 3 years before randomization
- Active or uncontrolled infections
- Unstable angina, congestive heart failure [NYHA>classII], uncontrolled hypertension [diastolic >100mmHg], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction
- Less than 4 weeks since receipt of any investigational product or device
- Pregnant or breast feeding
- Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
- Previously enrolled in this study
- Will not be available for follow-up assessments
- Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Hematologic responses
기간: 4 months
|
Marrow blast decrement
|
4 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Peter L Greenberg, Stanford University
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. .