EUCTR2017-001051-32-IT进行中（未招募）1 期
A Phase 1/2, Multicenter, Open-label Study of FT 2102 as a Single Agent and in Combination with Azacitidine or Cytarabine in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome with an IDH1 Mutation. - Study to evaluate FT-2102 as a single agent or in combination with Azacitidine or Cytarabine in pati
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 529
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Pathologically proven AML (except acute promyelocytic leukemia with the
- •t(15;17) translocation) or intermediate, high risk or very high risk MDS as
- •defined by the World Health Organization (WHO) criteria or Revised
- •International Prognostic Scoring System (IPSS-R) harboring IDH1-R132
- •mutations, and one of the following based on enrollment stage or treatment
- •a.Single Agent Phase 1 Cohorts including Dose-Escalation/ Dose-Expansion:
- •AML/MDS either R/R to standard therapy, or for whom standard treatments
- •are contra-indicated b.Combination (FT-2102 + azacitidine) Phase 1 Dose-
- •Escalation/ Dose-Expansion (patients must meet one of the following):
- •i. Patients with AML that is either R/R to standard therapy, or for whom
- •standard treatments are contraindicated
- •ii. Patients that have MDS that is either R/R to standard therapy, or are
- •treatment-naïve, who are eligible for azacitidine therapy
- •c.Combination (FT-2102 + Cytarabine) Phase 1 Dose-Escalation/Dose-
- •Expansion Cohort: Patients = 60 years with treatment-naïve AML for whom
- •standard treatments are contraindicated
- •d.Phase 2 Cohort 1 (Single Agent) only: AML R/R to standard therapy
- •e.Phase 2 Cohort 2 (Single Agent) only: AML in morphologic CR/CRi after prior
- •therapy HSCT with residual IDH1-R132 mutation (= 0.01%) detected in the
- •bone marrow
- •f.Phase 2 Cohort 3 (Single Agent) only: R/R AML/MDS that have been
- •previously treated with IDH1 inhibitor therapy AND for whom standard
- •treatments are contra-indicated
- •g.Phase 2 Cohort 4 (FT-2102 + Azacitidine) only: Patients < 60 years old with
- •R/R AML/MDS with no prior hypomethylating agent therapy AND no prior
- •IDH-1 inhibitor therapy
- •h.Phase 2 Cohort 5 (FT-2102 + Azacitidine) only: R/R AML/MDS that have
- •inadequately responded to or have progressed on prior treatment with a
- •hypomethylating agent
- •i.Phase 2 Cohort 6 (FT-2102 + Azacitidine) only: R/R AML/MDS that have
- •been previously treated with a single agent IDH-1 inhibitor as their last
- •therapy prior to study enrollment
- •j.Phase 2 Cohort 7 (Single Agent) only: Treatment nNaïve AML patients for
- •whom standard treatments are contraindicated
- •k.Phase 2 Cohort 8 (FT-2102 + Azacitidine) only: Treatment naïve AML
- •patients who are candidates for azacitidine first line treatment................
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Phase 1 Single Agent Dose-escalation/Dose-expansion Cohorts and Phase 2
- •Cohorts 1, 4, 5, 7 and 8 only: Patients who have been treated with an IDH1
- •targeted therapy are excluded
- •2.Phase 2 Single Agent Cohorts 1-3 and 7 only: Patients with IDH2 mutation
- •detection at baseline or history of IDH2m inhibitor treatment are excluded
- •3.History of prior malignancy unless disease-free for = 12 months or
- •considered surgically cured; patients with nonmelanoma skin cancers or with
- •carcinomas in situ are eligible regardless of the time from diagnosis (including
- •concomitant diagnoses)
- •4.Patients with symptomatic central nervous system (CNS) metastases or
- •other tumor location (such as spinal cord compression, other compressive
- •mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent
- •therapeutic intervention, palliative care, surgery or radiation therapy
- •5. Patients with previous allogeneic HSCT if they meet any of the following
- •criteria: < 100 days from time of HSCT; active acute or chronic graft vs. host
- •disease (GvHD); or receiving immunosuppressive therapy as treatment or
- •prophylaxis against GvHD Note: Doses < 20 mg methylprednisolone (or its
- •equivalent) daily are not an exclusion criterion
- •6.Treatment with radiation therapy, major surgery (requiring general
- •anesthesia) within one month prior to study drug dosing
- •7.Treatment with chemotherapy or small molecule anticancer therapeutic
- •within five half-lives of the agent or within 21 days if the half-life is unknown.
- •Patients re-enrolling in Cohort 6 after relapse/progression on Cohort 1 are
- •exempt from this washout requirement (i.e. can continue FT-2102 treatment
- •until re-enrollment)
- •8.Treatment with an anticancer therapeutic antibody less than four weeks
- •before first dose of study drug
- •9.Treatment with other experimental therapies or participation in another
- •clinical trial within a period of time that is less than the cycle length or within
- •21 days prior to starting study drug, whichever is shorter
- •10.Patients unable to swallow oral medications, or patients with
- •gastrointestinal conditions (e.g., malabsorption, resection, etc.) deemed by
- •the Investigator to jeopardize intestinal absorption
- •11.Congestive heart failure (New York Heart Association Class III or IV) or
- •unstable angina pectoris; previous history of myocardial infarction within one
- •year prior to study entry, uncontrolled hypertension, or uncontrolled
- •arrhythmias (see Appendix 4)
- •12.Patients with a family history of QT prolongation
- •13.Concomitant medication(s) known to cause Torsades..............
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