NCT03557970终止2 期
A Phase 2 Open-Label Study of the CSF-1R Inhibitor JNJ-40346527 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Best Objective Response Rate
研究概览
简要总结
This phase II trial studies how well edicotinib (JNJ-40346527) works in treating participants with acute myeloid leukemia that has come back or does not respond to treatment. JNJ-40346527 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
详细描述
PRIMARY OBJECTIVE:
Evaluate preliminary efficacy of JNJ-40346527 in participants with relapsed/refractory AML.
I. Best objective response rate (> PR).
SECONDARY OBJECTIVES:
Assess safety and survival associated with JNJ-40346527 to treat participants with relapsed/refractory AML. Assess the duration of disease response associated with JNJ-40346527.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and the willingness to sign a written informed consent document.
- •Age >= 18 years at time of informed consent. Both men and women and members of all races and ethnic groups will be included.
- •Morphologically documented relapsed/refractory AML as defined by World Health Organization (WHO) criteria after at least 1 prior therapy for AML with the exception of hydroxyurea, and not felt to have curative treatment options per treating physician, or the patients themselves are unwilling to consider curative treatment options.
- •Sufficient and viable bone marrow aspirate or peripheral blood collection to use for the ex vivo sensitivity assay.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to
- •Women must not be pregnant or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to start of study drug administration.
- •Participants must agree to use an adequate method contraception.
- •Must be able to take oral medications.
- •Adequate organ function as defined by the following:
- •Serum creatinine =< 2 x the upper limit of normal (ULN), or glomerular filtration rate > 20 ml/min as calculated by Cockcroft-Gault formula.
- •Serum potassium, magnesium, and calcium (corrected for albumin) within institutional normal limits or can be corrected with supplementation.
- •Total serum bilirubin =< 2.5 x ULN.
- •Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) =< 2.5 x ULN.
排除标准
- •Diagnosis of acute promyelocytic leukemia (APL, or AML M3 subtype).
- •Active central nervous system involvement with AML.
- •Concurrent active malignancy with expected survival of less than 1 year. For example, candidates with treated skin cancers, prostate cancer, breast cancer, etc. without metastatic disease are candidates for therapy since their expected survival exceeds that of relapsed or refractory AML. All subjects with concurrent malignancies will be reviewed by the principal investigator (PI) prior to enrollment.
- •Clinically significant graft versus host disease (GVHD) or active GVHD requiring initiation or escalation of treatment within 28-day screening period.
- •Clinically significant coagulation abnormality, such as disseminated intravascular coagulation.
- •Participants who are currently receiving any other investigational agents.
- •Previous treatment with CSF-1R kinase inhibitor or CSF-1R blocking antibody.
- •Known clinically significant liver disease defined as ongoing drug-induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, portal hypertension, or history of autoimmune hepatitis.
- •Untreated HIV or active hepatitis C detectable by polymerase chain reaction (PCR), or chronic hepatitis B (patients positive for hepatitis B core antibody who are receiving intravenous immunoglobulin (IVIG) are eligible if hepatitis B [HepB] polymerase chain reaction [PCR] is negative).
- •Known history of cerebrovascular accident, myocardial infarction, or intracranial hemorrhage within 2 months of enrollment.
- •Clinically significant surgery within 2 weeks of enrollment.
- •Per PI discretion, active infection that is not well controlled by antibacterial or antiviral therapy.
- •Cancer-directed therapy within 2 weeks prior to starting treatment, with the exception of hydroxyurea, which is allowed to control white blood cell count. Hydroxyurea will be weaned as soon as clinically feasible.
- •Unwillingness to receive infusion of blood products.
- •Drugs that affect the CYP3A4 systems are allowed and essential for cancer patients, including anti-fungals but should be used with caution.
- •Patients with uncontrolled white blood cell count (defined as > 50 K/cu mm not controlled with hydrea).
研究组 & 干预措施
Treatment (JNJ-40346527)
Experimental
Participants receive JNJ-40346527 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Edicotinib (Drug)
Treatment (JNJ-40346527)
Experimental
Participants receive JNJ-40346527 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Pharmacokinetic Study (Other)
结局指标
主要结局
Best Objective Response Rate
时间窗: first 2 cycles of study drug
An objective response is defined as achievement of a PR or any type of CR (CR, CRm, CRc, CRi) during a participant's first 2 cycles of study drug. Each participant's best disease response designation (amended from the IWG criteria specified by Cheson, 2003 JCO) during the first 2 cycles will be used when computing the best objective response rate. This rate will be reported alongside an exact confidence interval for each arm separately.
次要结局
- Incidence of Treatment-related and Non-treatment Related Adverse Events Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0(Start of study drug until 30 days after the last dose of study drug (while the participant remains on-study), which amounted to an average of 31 days for the 3 enrolled participants)
- Duration of Response(achievement of >=PR through end of study)
- Event-free Survival(study enrollment until last on-study disease assessment)
- Overall Survival(From study enrollment until end of participant follow-up (i.e., death or last contact), with the protocol specifying that "[p]articipants will be followed … until death")
研究者
Elie Traer, MD PhD
Principal Investigator
OHSU Knight Cancer Institute
研究点 (1)
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