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Trial record 1 of 1 for:    QuANTUM-R
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(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Daiichi Sankyo Inc.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT02039726
First received: January 15, 2014
Last updated: June 23, 2017
Last verified: June 2017
  Purpose
The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy.

Condition Intervention Phase
AML Drug: Quizartinib Drug: Salvage Chemotherapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 3 Open-label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects With Tyrosine Kinase 3 - Internal Tandem Duplication (FLT3-ITD) Positive Acute Myeloid Leukemia (AML) Refractory to or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 209 weeks ]
    Time (weeks) from the date of randomization to the date of death due to any cause


Secondary Outcome Measures:
  • Event-Free Survival [ Time Frame: 209 weeks ]
    Time (weeks) from randomization until documented refractory disease, relapse after complete composite remission (CRc), or death from any cause, whichever is observed first


Estimated Enrollment: 363
Study Start Date: April 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quizartinib
20 or 30 mg quizartinib tablets
Drug: Quizartinib
no details to specify
Other Name: AC220
Active Comparator: Salvage chemotherapy
Low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA)
Drug: Salvage Chemotherapy
No details to specify.
Other Name: Standard of Care

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of written informed consent approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) with privacy language in accordance with national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization for United States [US] sites) prior to any study related procedures, including withdrawal of prohibited medications if applicable.
  2. Age ≥ 18 years or the minimum legal adult age (whichever is greater) at the time of Informed consent.
  3. Morphologically documented primary Acute Myeloid Leukemia (AML) or AML secondary to Myelodysplastic Syndrome (MDS), as defined by World Health Organization (WHO) criteria, as determined by pathology review at the study site.
  4. In first relapse (with duration of remission of 6 months or less) or refractory after prior therapy, with or without HSCT. Induction therapy must have included at least 1 cycle of an anthracycline/mitoxantrone-containing induction block at a standard dose.
  5. Presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood (allelic ratio as determined by a central laboratory with a cutoff of ≥3% FLT3-ITD/total FLT3). If a specimen has been sent for FLT3-ITD testing at the central laboratory but the subject requires treatment for AML before the central FLT3-ITD test result is available, a local test result may be acceptable for randomization after consultation with the Medical Monitor.
  6. Eligibility for pre-selected salvage chemotherapy, according to the Investigator's assessment.
  7. Eastern Cooperative Oncology Group (ECOG) performance score 0-2.
  8. Discontinuation of prior AML treatment before the start of study treatment (except hydroxyurea or other treatment to control leukocytosis) for at least 2 weeks for cytotoxic agents, or for at least 5 half-lives for non cytotoxic agents.
  9. Serum creatinine ≤1.5×upper limit of normal (ULN), or glomerular filtration rate >25 mL/min, as calculated with the Cockcroft-Gault formula.
  10. Serum potassium, magnesium, and calcium (serum calcium corrected for hypoalbuminemia) within institutional normal limits. Subjects with electrolytes outside the normal range will be eligible if these values are corrected upon retesting following any necessary supplementation.
  11. Total serum bilirubin ≤1.5×ULN.
  12. Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤2.5×ULN.

Exclusion Criteria:

  1. Acute Promyelocytic Leukemia (AML subtype M3).
  2. AML secondary to prior chemotherapy for other neoplasms, except AML secondary to prior Myelodysplastic Syndrome (MDS).
  3. History of another malignancy, unless the candidate has been disease-free for at least 5 years.
  4. Persistent, clinically significant > Grade 1 non-hematologic toxicity from prior AML therapy.
  5. Clinically significant graft versus host disease (GVHD) or GVHD requiring initiation of treatment or treatment escalation within 21 days, and/or > Grade 1 persistent or clinically significant non hematologic toxicity related to HSCT.
  6. History of or current, central nervous system involvement with AML.
  7. Clinically significant coagulation abnormality, such as disseminated intravascular coagulation.
  8. Prior treatment with quizartinib or participated in a prior quizartinib study.
  9. Prior treatment with a FLT3 targeted therapy including sorafenib or investigational FLT3 inhibitors (not including the multi-kinase inhibitor, midostaurin).
  10. Major surgery within 4 weeks prior to screening.
  11. Radiation therapy within 4 weeks prior to screening.
  12. Uncontrolled or significant cardiovascular disease
  13. Active infection not well controlled by antibacterial or antiviral therapy.
  14. Known infection with human immunodeficiency virus, or active hepatitis B or C, or other active clinically relevant liver disease.
  15. Unwillingness to receive infusion of blood products according to the protocol.
  16. In a man whose sexual partner is a woman of childbearing potential, unwillingness or inability of the man or woman to use a highly effective contraceptive method for the entire study treatment period for at least 3 months after study completion. Male subjects must not freeze or donate sperm starting at Screening and throughout the study period, and 105 days after the final study drug administration.
  17. In a heterosexually active woman of childbearing potential, unwillingness or inability to use a highly effective contraceptive method for the entire study treatment period and for at least 3 months after study treatment completion. Additionally, for women randomized to chemotherapy, unwillingness to adhere to the restrictions in the respective locally established guidelines and local approved label (prescribing information, Summary of Product Characteristics, or US product insert) from the manufacturer and the Patient Information Leaflet (package insert) as instructed by the Investigator.
  18. Pregnancy.
  19. Female Subjects must agree to not breastfeed from the time of Screening and throughout the study period, and for 25 days after the final study drug administration.
  20. Medical condition, serious intercurrent illness, or other circumstance that, in the Investigator's judgment, could jeopardize the candidate's safety as a study subject, or that could interfere with study objectives.
  21. For subjects in the UK only: Refusal of permission to allow the subject's General Practitioner to be notified of their participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02039726

  Show 141 Study Locations
Sponsors and Collaborators
Daiichi Sankyo Inc.
Investigators
Principal Investigator: Jorge E. Cortes, MD M.D. Anderson Cancer Center
Study Director: Global Clinical Leader Daiichi Sankyo Inc.
  More Information

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT02039726     History of Changes
Other Study ID Numbers: AC220-007
EudraCT Number 2013-004890-28 ( Other Identifier: Universal Trial Number (UTN) U1111-1151-8078 )
Study First Received: January 15, 2014
Last Updated: June 23, 2017

Keywords provided by Daiichi Sankyo Inc.:
Acute Myeloid Leukemia
AML
FMS-like tyrosine kinase 3
FLT3-ITD
Quizartinib
Leukemia
Tablets

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 27, 2017