Status:
WITHDRAWN
ASTX727 and FT-2102 in Treating IDH1-Mutated Recurrent/Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
Astex Pharmaceuticals, Inc.
Forma Therapeutics, Inc.
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase Ib/II trial studies the side effects and best dose of FT-2102 when given together with ASTX727 in treating patients with IDH1-mutated myelodysplastic syndrome or acute myeloid leukemia that...
Detailed Description
PRIMARY OBJECTIVES: * To evaluate the safety of IDH-1 inhibitor FT-2102 (FT-2102) in combination with CDA inhibitor E7727/decitabine combination agent ASTX727 (ASTX727) in myelodysplastic syndrome (M...
Eligibility Criteria
Inclusion
- Must voluntarily sign an informed consent document (ICF)
- Morphologically confirmed diagnosis of MDS (inclusive of MDS/MPN) or AML in accordance with World Health Organization (WHO) diagnostic criteria
- Phase Ib: Subjects may have
- Relapsed/refractory AML or MDS or
- Treatment naive AML
- Phase II Expansion: Subjects may have
- Relapsed/refractory AML or MDS or
- Treatment naive AML or
- Treatment naive MDS
- For patients with MDS, must have a Revised International Prognostics Scoring System (IPSS-R) risk category of intermediate, high, or very high
- Confirmed IDH1 R132 mutation
- A bone marrow biopsy must be performed and tissue collected for entrance to the trial
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Life expectancy of at least 3 months in the assessment of the investigator
- Recovery from the non-hematologic toxic effects of prior treatment to grade =\< 1, or baseline value according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 classification (excluding infertility, alopecia, or grade 1 neuropathy)
- Must have adequate hepatic and renal function as demonstrated by the following:
- ALT (SGPT) and/or AST (SGOT) ≤ 3x upper limit of normal (ULN); Direct bilirubin ≤ 1.5 x ULN(or ≤ 2x ULN if due to Gilbert's disease); Serum creatinine of 1.5 x ULN or creatinine clearance of \> 50 mL/min (whichever is lower)
- Baseline Fridericia's correction formula (QTcF) =\< 450 msec (average of the QTcF values of screening triplicate electrocardiography \[ECG\]swith approximately two-minute intervals ) except for those patients with a bundle branch block (BBB)
- For fertile men and women, agreement to use effective contraceptive methods for the duration of study participation and 90 days after the last dose of study medication
Exclusion
- Treatment naive patients who are suitable for and willing to receive intensive induction chemotherapy
- Patients with active, uncontrolled infection. Patients with infection under active treatment and controlled with antibiotics are eligible
- Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol
- Known history of human immunodeficiency virus (HIV), or known active hepatitis A, B, or C infection (hepatitis B carriers with normal liver function test \[LFT\]s and undetectable viral loads are allowed)
- Women who are pregnant or nursing
- Organ transplant recipients other than bone marrow transplant
- Autologous hematologic stem cell transplant within 3 months of study entry. Allogeneic hematologic stem cell transplant within 6 months. Grade II, or greater, active graft-versus- host disease
- Use of an investigational drug within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of FT-2102/ASTX727. For investigational drugs for which 5 half-lives is less than 21 days, a minimum of 10 days between termination of the investigational drug and administration of FT-2102/ASTX727 is required
- Any major surgery, chemotherapy, or immunotherapy within the last 21 days (limited palliative radiation is allowed \>= 2 weeks); concurrent hydroxyurea is allowed if less than or equal to 2 grams daily
- Ongoing immunosuppressive therapy including systemic corticosteroids (prednisone or equivalent =\< 20 mg daily allowed as clinically warranted). Patients are allowed to use topical or inhaled corticosteroids
- Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.
- Patients unable to swallow oral medications, or patients with gastrointestinal conditions (e.g., malabsorption, resection, etc.) deemed by the Investigator to jeopardize intestinal absorption
- Patients receiving intrathecal chemotherapy for active central nervous system (CNS) disease
- Patients who have exhibited allergic reactions to a previously administered IDH1 inhibitor
- Patients with acute promyelocytic leukemia (APL)
Key Trial Info
Start Date :
August 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04013880
Start Date
August 27 2019
End Date
March 31 2022
Last Update
July 7 2020
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