- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00005845
Tipifarnib in Treating Patients With Myelodysplastic Syndromes
Phase I Study of the Farnesyl Transferase Inhibitor R115777 (NSC #702818) in Patients With Myelodysplastic Syndrome
연구 개요
상태
정황
개입 / 치료
상세 설명
PRIMARY OBJECTIVES:
I. To determine the toxicity profile and antitumor activity of the farnesyltransferase (FTase) inhibitor R115777 (tipifarnib) in patients with myelodysplastic syndrome (MDS) treated on a one week on/one week off schedule.
II. To determine the effect on R115777 on a one week on/one week off schedule on FTase activity, prenylation of RAS and other substrates and on downstream effects.
OUTLINE: This is a dose-escalation study.
Patients receive tipifarnib orally (PO) twice daily (BID) on weeks 1, 3, 5, and 7. Treatment repeats every 8 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
-
-
Texas
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Houston, Texas, 미국, 77030
- M D Anderson Cancer Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Patients must have histologically MDS (including French-American-British [FAB] types refractory anemia [RA], refractory anemia with ringed sideroblasts [RARS], refractory anemia with excess blasts [RAEB], refractory anemia with excess blasts in transformation [RAEBT], or chronic myelomonocytic leukemia [CMMoL]); for the purpose of the study, all patients will be classified by World Health Organization (WHO) criteria
- By these criteria, FAB RA are split into:
Pure dyserythropoietic refractory anemia (PRA)
- Refractory cytopenia with multilineage dysplasia (RCMD)
FAB RARS is split into:
- Pure sideroblastic anemia (PSA)
- Refractory sideroblastic cytopenia with multilineage dysplasia (RSCMD)
FAB RAEB is split into:
- RAEB I (< 10% BM blasts)
- RAEB II (10-20% BM blasts)
- Patients with CMMoL, and RAEBT by FAB classification will be included in the protocol
- Prognosis will be assessed by International Prognostic Scoring System (IPSS) criteria
- =< 2 prior therapies
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Life expectancy of greater than 12 weeks
- Bilirubin =< 1.5mg %
- Creatinine =< 1.5mg %
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 4 weeks (3 months for UCN01) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to R115777 (such as imidazoles)
- Patients eligible for bone marrow transplant (=< 60 years old), with a compatible sibling, no contraindications for transplant
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with R115777.
- Growth factors other than filgrastim (G-CSF) are excluded; patients should be off excluded growth factors for 2 weeks
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Treatment (tipifarnib)
Patients receive tipifarnib PO BID on weeks 1, 3, 5, and 7. Treatment repeats every 8 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
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상관 연구
상관 연구
다른 이름들:
주어진 PO
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
MTD defined as the next lower dose level at which 2 patients experience dose limiting toxicity (DLT) defined as grade 3 or 4 toxicity according to the Cancer Therapy Evaluation Program Common Toxicity Criteria
기간: Up to 8.5 years
|
The final analysis will report all toxicities by grade, dose, cycle, and by cumulative dose.
|
Up to 8.5 years
|
Response rate
기간: Up to 8.5 years
|
Will be reported overall and by dose level.
|
Up to 8.5 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
FTase inhibition
기간: Up to 8.5 years
|
Based on the shape of the relationship (e.g.
linear vs saturation vs peak), a dose response analysis will be performed to describe/summarize the relationship (correlation analysis or curve-fitting).
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Up to 8.5 years
|
Accumulation of unfarnesylated lamin B1
기간: Up to 8.5 years
|
Based on the shape of the relationship (e.g.
linear vs saturation vs peak), a dose response analysis will be performed to describe/summarize the relationship (correlation analysis or curve-fitting).
|
Up to 8.5 years
|
Accumulation of RAS proteins
기간: Up to 8.5 years
|
Based on the shape of the relationship (e.g.
linear vs saturation vs peak), a dose response analysis will be performed to describe/summarize the relationship (correlation analysis or curve-fitting).
|
Up to 8.5 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Razelle Kurzrock, M.D. Anderson Cancer Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 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
- NCI-2009-01158 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- U01CA062461 (미국 NIH 보조금/계약)
- 5625 (기타 식별자: CTEP)
- CDR0000067862
- DM01-582 (기타 식별자: M D Anderson Cancer Center)
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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