- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00907517
Study of SCH 900776 (MK-8776) With and Without Cytarabine in Participants With Acute Leukemias (P05247)
2018년 7월 26일 업데이트: Merck Sharp & Dohme LLC
A Phase 1 Dose-Escalation Study of SCH 900776 in Combination With Cytarabine in Subjects With Acute Leukemias (Protocol No. P05247)
This study of SCH 900776 (MK-8776) will evaluate its safety and tolerability when given in combination with cytarabine to participants with acute leukemias.
Participants in the Dose-Escalation Part will be enrolled in cohorts that will receive sequentially higher doses of MK-8776 in combination with standard doses of cytarabine.
Only one combination treatment cycle of approximately 4 to 6 weeks is anticipated, but participants may receive additional cycles if clinically indicated after discussion between the Investigator and the Sponsor.
The recommended combination doses for a Phase 2 trial (RP2D) will be determined based on safety and biological activity.
Up to 10 to 15 additional participants will be studied at the combination RP2D.
연구 개요
상태
종료됨
개입 / 치료
연구 유형
중재적
등록 (실제)
24
단계
- 1단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
Must have a histologically or cytologically confirmed diagnosis of relapsed and/or refractory acute leukemia, including:
- acute myelogenous leukemia (AML), including AML arising from myelodysplasia (MDS) or myeloproliferative disorder (MPD);
- acute lymphocytic leukemia, including Philadelphia chromosome-positive (Ph+) ALL (Dose-Escalation Part only);
- chronic myelogenous leukemia (CML) in accelerated phase (AP) or blast crisis (BC) of either myeloid or lymphoid origin (Dose-Escalation Part only);
- treatment-related high-grade MDS (i.e. refractory anemia with excess blasts in transformation [RAEBT]);
- MPD in transformation [eg, CMMoL-T (5%-19% blasts)].
- Must have recurred or progressed following standard therapy or failed standard therapy, or have disease for which no standard therapy currently exists.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Females of childbearing potential must have a negative pregnancy test within 5 days prior to first dose of cytarabine.
- Females of childbearing potential and males whose sexual partner is of childbearing potential must agree to abstain from sexual intercourse or to use an acceptable method of contraception during the study and for 90 days following the last dose of study treatment.
- Must have adequate renal function as evidenced by a serum creatinine level <=1.5 x upper limit of normal (ULN) or a calculated creatinine clearance >=60 mL/min.
- Participants, except ones with known Gilbert's Syndrome, must have adequate hepatic function as evidenced by a serum bilirubin level <=1.5 mg/dL AND serum levels of aspartate and alanine aminotransferase (AST/ALT) <=5 x the ULN for the reference laboratory.
- Must have adequate cardiac function with a left ventricular ejection fraction (LVEF) of >=45% (echocardiogram or multiple-gated acquisition [MUGA] scan).
- Must be recovered from the effects of any prior surgery, radiotherapy, or systemic antineoplastic therapy.
- Participants who are refractory to or relapsed after prior allogeneic or autologous stem cell transplant are eligible.
Exclusion Criteria:
- Must not have known hypersensitivity to MK-8776 or cytarabine or to any of their excipients or have received therapy with another Checkpoint kinase 1 (CHK1) inhibitor.
- Must not have persistent, unresolved Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0) ≥ Grade 2 drug-related toxicity (except alopecia, erectile impotence, hot flashes, decreased libido, hematologic toxicity) associated with previous treatment.
- Must not have known human immunodeficiency virus (HIV), hepatitis B or hepatitis C, or have a known history of liver cirrhosis or active alcohol abuse.
- Must not be New York Heart Association (NYHA) Class III (has marked limitation in activity due to symptoms, even during less than ordinary activity [e.g. walking short distances >20-100 m]; is comfortable only at rest) or Class IV (has severe limitations; experiences symptoms even while at rest; mostly bed bound).
- Must not have undergone major surgery within 3 weeks prior to first study drug administration after enrollment.
- Must not have known active central nervous system (CNS) or leptomeningeal leukemia.
- Must not have received radiation therapy within 2 weeks prior to first study treatment administration after enrollment or radiation therapy to >25% of bone marrow.
- Must not have received more than 4 prior induction regimens.
- Must not have a peripheral blast count ≥50,000/mm^3.
- Must not have active, uncontrolled graft versus host disease (GVHD) post-allogeneic stem cell transplant.
- Must not have had any of the following within 6 months prior to first study treatment administration after enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or seizure disorder.
- Must not have a known bleeding diathesis, e.g. hemophilia, or disseminated intravascular coagulation.
- Must not have an active, uncontrolled infection.
- Must not have a history of cytarabine-related neurotoxicity.
- Must not have a baseline corrected QT (QTc) interval >470 msec (i.e. CTCAE v 3.0 Grade ≥2).
- Must not currently be a smoker and/or must not be likely to smoke during the study.
- Females must not be breast-feeding, pregnant, or intend to become pregnant.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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 |
---|---|
실험적: MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2
Participants received MK-8776 10 mg/m^2 intravenously (IV) on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour continuous intravenous infusion (CIV) on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle.
The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
|
IV 주입
다른 이름들:
IV infusion
다른 이름들:
|
실험적: MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2
Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle.
The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
|
IV 주입
다른 이름들:
IV infusion
다른 이름들:
|
실험적: MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2
Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle.
The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
|
IV 주입
다른 이름들:
IV infusion
다른 이름들:
|
실험적: MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2
Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle.
The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
|
IV 주입
다른 이름들:
IV infusion
다른 이름들:
|
실험적: MK-8776 140 mg + Cytarabine 2 g/m^2
Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle.
The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
|
IV 주입
다른 이름들:
IV infusion
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
기간: Throughout Cycle 1 (Up to 6 weeks)
|
Toxicity was assessed according to the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0).
DLTs in Cycle 1 consisted of any of the following: 1) Selected Grade 4 drug-related nonhematologic toxicities, 2) Selected Grade 3 drug-related nonhematologic toxicities that do not resolve to ≤ Grade 2 within 48 hours: Neurotoxicity of any duration, Nephrotoxicity of any duration, QT interval corrected by Fridericia (QTcF) prolongation of any duration, 3) Inability to administer Day 10 cytarabine therapy due to ongoing, uncontrolled serious or life-threatening toxicity.
The number of participants who experienced a DLT during Cycle 1 is summarized.
|
Throughout Cycle 1 (Up to 6 weeks)
|
Number of Participants Who Experienced an Adverse Event (AE)
기간: Up to 45 days after last dose of study treatment (Up to 180 days)
|
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to this study treatment.
The number of participants who experienced an AE is summarized.
|
Up to 45 days after last dose of study treatment (Up to 180 days)
|
Number of Participants Who Discontinued Study Treatment Due to an AE
기간: Up to 135 days
|
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to this study treatment.
The number of participants who discontinued study treatment due to an AE is summarized.
|
Up to 135 days
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2009년 7월 29일
기본 완료 (실제)
2011년 6월 13일
연구 완료 (실제)
2011년 6월 13일
연구 등록 날짜
최초 제출
2009년 5월 21일
QC 기준을 충족하는 최초 제출
2009년 5월 21일
처음 게시됨 (추정)
2009년 5월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 8월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 7월 26일
마지막으로 확인됨
2018년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- P05247
- MK-8776-001 (기타 식별자: Merck Protocol Number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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. .
백혈병, 림프구성, 급성에 대한 임상 시험
MK-8776에 대한 임상 시험
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Merck Sharp & Dohme LLC완전한신생물 | 림프종, 비호지킨 | 호지킨병
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Merck Sharp & Dohme LLC종료됨
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