A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes
This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndromes (MDS) will receive investigational study drug ARRY-614.
This study has 2 parts. In the first part, patients will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 50 patients from the US will be enrolled in Part 1 (Completed).
In the second part of the study, patients will receive the best dose of study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in Part 2 (Completed).
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Florida
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Tampa, Florida, 미국, 33612
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University, Winship Cancer Institute
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Ohio
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Cleveland, Ohio, 미국, 44195
- Cleveland Clinic
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Texas
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Houston, Texas, 미국, 77030
- MD Anderson Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria (Part 1 and Part 2):
- Diagnosis of MDS by bone marrow biopsy.
- International Prognostic Scoring System (IPSS) score of low or intermediate-1 risk MDS.
- May have received prior therapy for MDS.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
- Adequate liver and renal function.
- Additional criteria exist.
Key Exclusion Criteria (Part 1 and Part 2):
- History of bone marrow transplant.
- Treatment for MDS other than transfusions or a stable dose (≥ 4 weeks) of hematopoietic growth factors on the day of the first dose of study drug.
- Concomitant malignancies or previous malignancies with less than a 2-year disease-free interval at the time of enrollment.
- Treatment with an investigational medicinal product that is not expected to be cleared by the first dose of study drug or that has demonstrated to have prolonged side effects.
- Treatment with azacitidine or decitabine within 2 weeks prior to first dose of study drug.
- Chronic use (> 2 weeks) of greater than physiologic doses of corticosteroids (dose equivalent to > 20 mg/day of prednisone) within 4 weeks prior to first dose of study drug.
- Treatment with an immunomodulatory agent within 4 weeks prior to the first dose of study drug.
- Additional criteria exist.
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 |
|---|---|
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실험적: ARRY-614
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Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Establish the maximum tolerated dose (MTD) of study drug.
기간: Part 1, 9 months
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Part 1, 9 months
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Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
기간: Part 1, 9 months; Part 2, 9 months
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Part 1, 9 months; Part 2, 9 months
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Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
기간: Part 1, 9 months; Part 2, 9 months
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Part 1, 9 months; Part 2, 9 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Assess the efficacy of the study drug in terms of response, time to response, duration of response, overall survival, hematologic improvement and platelet transfusion independence/reduction.
기간: Part 1, 9 months; Part 2, 9 months
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Part 1, 9 months; Part 2, 9 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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. .
ARRY-614, p38/Tie2 inhibitor; oral에 대한 임상 시험
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Array Biopharma, now a wholly owned subsidiary...완전한