Study to evaluate FT-2102 as a single agent or in combination with Azacitidine or Cytarabine in patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome.
- Conditions
- Relapsed/refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2017-001051-32-IT
- Lead Sponsor
- FORMA THERAPEUTICS, INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 529
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
cohort:
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
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..............
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method