NL-OMON55457已完成不适用
A Multicenter Phase 1, Open-Label Study of DCC-2618 to Assess Safety, Tolerability, Efficacy, and Pharmacokinetics in Patients with Advanced Malignancies - A phase I, open-label study of DCC-2618 in advanced malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion Criteria
- •Patients must meet the following criteria to be eligible to enroll in the study:
- •1. Patients must have histologically confirmed solid tumors or hematologic
- •malignancies. Eligible patients include the following:
- •a. GIST patients must have a KIT or PDGFRA mutation and must have progressed on
- •or had an intolerability to at least 1 line of systemic anticancer therapy:
- •i. Patients with a pre-existing resistance mutation to an approved line of
- •therapy are eligible. For example, imatinib resistant mutations including KIT
- •Exon 17 and PDGFRA D842V.
- •b. Systemic mastocytosis (SM) patients must have a confirmed diagnosis
- •(confirmed by a central independent pathologist) of advanced SM according to
- •2016 World Health Organization (WHO) criteria for SM (15) and must have
- •documented KIT mutant disease. Patients with imatinib-sensitive KIT mutations
- •must have progressed on or were intolerant to a tyrosine kinase inhibitor.
- •Patients with advanced SM must present with at least 1 eligible C Finding
- •(organ damage) as outlined in Table 3 of the 2013 International Working Group
- •Myeloproliferative Neoplasms Research and Treatment (IWG MRT) & European
- •Competence Network on Mastocytosis (ECNM) consensus response criteria (Appendix
- •10.5); please see below for MCL exception.
- •Advanced SM includes:
- •i. Aggressive SM (ASM),
- •ii. SM-AHN, wherein the AHN does not require immediate alternative therapy,
- •such as acute myeloid leukemia. AHNs that are eligible include: low grade
- •myelodysplastic syndrome (MDS) with a high SM burden who require treatment for
- •SM only, myeloproliferative neoplasms (MPNs), MDS/MPN, unclassifiable MDS, and
- •Patients with histopathologically-confirmed MCL without a C finding are
- •iv. Symptomatic SSM
- •By definition, SSM patients must have at least 2 B-findings, and clinically
- •significant symptom burden (eg, flushing, diarrhea, etc.) despite maximal
- •treatment with approved agents to treat mediator symptoms, such as
- •antihistamines and cromolyn sodium.
- •v. Patients with hematologic malignancies featuring clonal expansion of
- •eosinophils driven by genomic alterations of KIT or PDGFR (eg, HES or CEL) must
- •have a diagnosis confirmed by a central independent pathologist and are
- •eligible if they have progressed on or are intolerant of imatinib therapy.
- •Patients with de novo imatinib resistant mutations, such as but not limited to
- •KIT D816V or PDGFRA D842V, are eligible without prior imatinib therapy.
- •c. Malignant glioma patients with genomic alterations potentially conferring
- •sensitivity to DCC 2618 including, but not limited to, amplification and/or
- •mutations of PDGFRA and/or KIT.
- •i. Patients must not require use of enzyme-inducing antiepileptic drugs
- •ii. Patients that require steroids must be on a stable dose for 2 weeks prior
- •to the first dose of study drug.
- •d. Other solid tumor patients that have alterations in genes encoding kinases
- •that are targets of DCC-2618. This includes KIT, PDGFR (A or B), TIE2, CSF1R,
- •and VEGFR2. Patients must have received approved treatments known to provide
- •clinical benefit prior to study entry.
- •e. Melanoma patients with mutations and/or amplification potentially conferring
- •sensitivity to DCC-2618 including KIT, PDGFR (A or B), TIE2, CSF1R, and VEGFR2
- •i. Patients must have a h
排除标准
- •Exclusion Criteria
- •Patients meeting any of the following criteria will be excluded from the study:
- •1. GIST patients with wild type or unknown KIT or PDGFRA status
- •2. Patients with SM or other hematologic malignancies will be excluded if the
- •following apply:
- •a) SM patients with neutropenia accompanied by fever or infection, or
- •thrombocytopenia associated with clinically significant bleeding.
- •Patients with an infection that is well controlled with antibiotics are
- •eligible if there is an immediate need for treatment
- •b) SM-AHN patients diagnosed with:
- •i. SM with MDS (SM-MDS) who require treatment.
- •ii. Patients requiring immediate treatment for AHN.
- •c) Patients with leukemias, with the exception of MCL and CEL, that have
- •progressed after imatinib.
- •d) Eosinophilic myeloproliferative neoplasm patients:
- •i. Lacking a mutation that is a known target of DCC-2618. This includes, but is
- •not limited to, fusions/mutations of fibroblast growth factor receptor 1
- •(FGFR1), Janus kinase 2 (JAK2), and Abelson murine leukemia viral oncogene
- •3. Prior or concurrent malignancy whose natural history or treatment have the
- •potential to interfere with the safety or efficacy assessment of DCC-2618.
- •Patients receiving adjuvant cancer treatment are not eligible if those
- •medications are potentially active against GIST or excluded per protocol.
- •4. Treatment with anticancer therapy, including investigational therapy, within
- •2 weeks prior to the administration of study drug, with the exception of
- •hydroxyurea that is allowed to control white blood cell count. For prior
- •therapies with a half-life longer than 3 days, the interval must be at least 28
- •days prior to the first administration of study drug.
- •5. New York Heart Association class III or IV heart disease, active ischemia or
- •any other uncontrolled cardiac condition such as angina pectoris, clinically
- •significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or
- •congestive heart failure.
- •6. Arterial thrombotic or embolic events such as cerebrovascular accident
- •(including ischemic attacks) or hemoptysis within 6 months before start of
- •study drug.
- •7. Venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial
- •events (eg, pulmonary embolism) within the 3 months before start of study drug.
- •Patients with venous thrombotic events >=3 months before start of study drug on
- •stable anticoagulation therapy are eligible.
- •8. Baseline prolongation of the rate-corrected QT interval based on repeated
- •demonstration of QTcF >450 ms in males or >470 ms in females or history of long
- •QT syndrome.
- •9. LVEF <50% or below the institute lower limit of normal (whichever is higher).
- •10. Major surgery within 4 weeks of the first dose of study drug; following
- •major surgeries >4 weeks prior to the first dose of study drug, all surgical
- •wounds must be healed and free of infection or dehiscence.
- •11. Any other clinically significant comorbidities, such as uncontrolled
- •pulmonary disease, active infection, or any other condition, which in the
- •judgment of the Investigator, could compromise compliance with the protocol,
- •interfere with the interpretation of study results, or predispose the patient
- •to safety risks.
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