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Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

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ClinicalTrials.gov Identifier: NCT03070093
Expanded Access Status : Available
First Posted : March 3, 2017
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief Summary:
The purpose of this study is to provide expanded access to ASP2215 for subjects with FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite complete remission (CRc) (complete remission [CR], complete remission with incomplete hematologic recovery [CRi], complete remission with incomplete platelet recovery [CRp]) with MRD without access to comparable or alternative therapy.

Condition or disease Intervention/treatment
Acute Myeloid Leukemia (AML) FMS-like Tyrosine Kinase-3 (FLT3) Mutations Drug: gilteritinib

Detailed Description:

This treatment protocol is being conducted while phase 3 ASP2215 studies are ongoing in FLT3-mutated AML subjects.

Subjects will complete visits on cycle 1 - days 1, 4, 8, 15; cycle 2 - days 1, 15; cycles 3 to 6 - day 1; and day 1 of every 2 cycles thereafter (i.e., cycle 8 day 1, cycle 10 day 1, etc.) until discontinued from the study.

Subjects will be provided with study medication until the investigator determines the subject is no longer receiving clinical benefit.

An end of treatment visit will be performed within 7 days after last dose of investigational product (ASP2215), or prior to initiation of another anticancer therapy, whichever occurs earlier, followed by a 30-day follow-up. [Specific to investigational sites in Japan: Study population does not include subjects with FLT3-mutated AML in CRc (CR, CRi, CRp) with MRD. Hence, efficacy (MRD response rate and duration of response) data will not be collected for subjects enrolled in Japan.]


Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: A Multicenter, Open-label Treatment Protocol of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)



Intervention Details:
  • Drug: gilteritinib
    oral
    Other Name: ASP2215

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Subject is considered an adult according to local regulation at the time of signing informed consent.
  • Subject has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) or therapy-related AML according to World Health Organization (WHO) classification.
  • Subject has presence of the FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in CRc (CR, CRi, CRp) with MRD in bone marrow or peripheral blood. [Specific to investigational sites in Japan: FLT3-mutated AML in CRc (CR, CRi, CRp) with MRD subjects will not be included.]
  • Subject has refractory or relapsed AML (with or without hematopoietic stem cell transplant [HSCT]) or AML in CRc (CR, CRi, CRp) with MRD by flow cytometry or genetic testing for the FLT3 mutation after induction/consolidation regimen or HSCT. [Specific to investigational sites in Japan: FLT3-mutated AML in CRc (CR, CRi, CRp) with MRD subjects will not be included.]
  • Subject must wait for at least 5 half-lives after stopping therapy with any investigational agent and before starting ASP2215.
  • Subject must meet the following criteria as indicated on clinical laboratory tests:

    • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x institutional upper limit of normal (ULN)
    • Serum total bilirubin ≤ 2.5 mg/dL, except for subjects with Gilbert's syndrome
    • Serum potassium and serum magnesium ≥ institutional lower limit of normal (LLN).
  • Subject is able to tolerate oral administration of study drug.
  • Subject who has developed overall grades II-IV acute graft-versus-host disease (GVHD) must satisfy the following criteria:

    • No requirement of > 0.5 mg/kg of prednisone (or equivalent) daily dose within 1 week of enrollment
    • No escalation of immunosuppression in terms of increase of corticosteroids or addition of new agent/modality in prior 2 weeks (note that increasing calcineurin inhibitors or sirolimus to achieve therapeutic trough levels is allowed)
  • Female subject must either:

    • Be of nonchildbearing potential:
    • Postmenopausal (defined as at least 1 year without any menses) prior to screening, or
    • Documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 1 month prior to screening.
    • Or, if of childbearing potential,
    • Agree not to try to become pregnant during the study and for at least 180 days after the final study drug administration
    • And have a negative urine pregnancy test at screening
    • And, if heterosexually active, agree to use consistently 2 forms of effective contraception per locally accepted standards (1 of which must be a barrier method) starting at screening and throughout the study period and for at least 180 days after the final study drug administration.
  • Female subject must agree not to breastfeed or donate ova starting at screening and throughout the study period, and for at least 180 days after the final study drug administration.
  • Male subject (even if surgically sterilized) and partners who are women of childbearing potential must agree to practice 2 forms of effective contraception per locally accepted standards

    (1 of which must be a barrier method), starting at screening and throughout the study period and for 120 days after the final study drug administration.

  • Male subject must not donate sperm starting at screening and throughout the study period and for 120 days after the final study drug administration.
  • Subject agrees not to participate in another interventional study for AML while on treatment.
  • Subject who has a diagnosis of HIV may be enrolled as long as the disease is under control on antiretroviral therapy. Precautions should be taken to modify highly active antiretroviral therapy (HAART) regimen to minimize drug interactions.
  • There is no comparable or satisfactory alternative therapy to treat the subject's AML.

Exclusion Criteria:

  • Subject is eligible to participate in an ongoing clinical study of ASP2215; or has previously participated in a randomized clinical study of ASP2215 with a primary endpoint of overall survival that is not closed for efficacy.
  • Subject with QTcF > 450 ms at screening based on local reading.
  • Subject with a known history of Long QT Syndrome at screening.
  • Subject was diagnosed with acute promyelocytic leukemia (APL).
  • Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
  • Subject has clinically significant coagulation abnormality unless secondary to AML.
  • Subject has active hepatitis B or C or an active hepatic disorder.
  • Subject has uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, or New York Heart Association (NYHA) Class IV heart failure.
  • Subject requires treatment with concomitant drugs that are strong inducers of CYP3A.
  • Subject has any condition which makes the subject unsuitable for study participation.
  • Subject has hypersensitivity to any of the study drug components.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070093


Contacts
Contact: Astellas Pharma Global Development 800-888-7704 astellas.registration@astellas.com

  Show 36 Study Locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
Study Director: Medical Director Astellas Pharma Global Development, Inc.

Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT03070093     History of Changes
Other Study ID Numbers: 2215-CL-9100
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
Acute myeloid leukemia (AML)
FMS-like Tyrosine kinase-3 (FLT3) mutations
gilteritinib
Expanded access
ASP2215

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes