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A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia

Primary Purpose

Acute Myeloid Leukemia (AML)

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
IDH305
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring newly diagnosed acute myeloid leukemia, AML, myeloid dysplastic syndrome, MDS, IDH305, standard of care in IDH1 mutant acute myeloid leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-- Previously untreated AML. Patients with untreated, high or very high risk MDS (according to rIPSS or equivalent) are also permitted in Arm 2.

  • Documentation of IDH1R132 mutation of tumor
  • ECOG performance status ≤ 2
  • Clinically fit for standard of care medication per protocol.

Exclusion Criteria:

  • Prior treatment for AML or MDS
  • Any severe or uncontrolled medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease.
  • Acute Promyelocytic Leukemia
  • Women who are pregnant or lactating

Other protocol-defined Inclusion/Exclusion may apply

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Arm 1: Medically fit for induction

    Arm 2 Medically unfit for induction

    Arm Description

    IDH305 + Standard of care for patients that are medically fit for induction.

    IDH305 + Standard of care for patients that are medically unfit for induction.

    Outcomes

    Primary Outcome Measures

    Dose Limiting toxicities
    (escalation only)
    Number of patients with adverse events (AEs)

    Secondary Outcome Measures

    Area Under Curve (AUC)
    To characterize the PK profile of IDH305 with SOC medications (each Arm)
    Maximum Plasma Concentration (Cmax)
    To characterize the PK profile of IDH305 with SOC medications (each Arm)
    Time taken to reach maximum plasma concentration (Tmax)
    To characterize the PK profile of IDH305 with SOC medications (each Arm)
    Complete remission rate (CRR)
    To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)
    Overall response rate (ORR)
    To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)
    Event free survival (EFS)
    To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)

    Full Information

    First Posted
    June 13, 2016
    Last Updated
    April 8, 2019
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02826642
    Brief Title
    A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia
    Official Title
    A Phase I, Open Label, Multicenter, Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    August 26, 2016 (Actual)
    Primary Completion Date
    November 29, 2016 (Anticipated)
    Study Completion Date
    November 29, 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety, tolerability and potential efficacy of IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia (AML).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Myeloid Leukemia (AML)
    Keywords
    newly diagnosed acute myeloid leukemia, AML, myeloid dysplastic syndrome, MDS, IDH305, standard of care in IDH1 mutant acute myeloid leukemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1: Medically fit for induction
    Arm Type
    Experimental
    Arm Description
    IDH305 + Standard of care for patients that are medically fit for induction.
    Arm Title
    Arm 2 Medically unfit for induction
    Arm Type
    Experimental
    Arm Description
    IDH305 + Standard of care for patients that are medically unfit for induction.
    Intervention Type
    Drug
    Intervention Name(s)
    IDH305
    Primary Outcome Measure Information:
    Title
    Dose Limiting toxicities
    Description
    (escalation only)
    Time Frame
    10 months
    Title
    Number of patients with adverse events (AEs)
    Time Frame
    36 months
    Secondary Outcome Measure Information:
    Title
    Area Under Curve (AUC)
    Description
    To characterize the PK profile of IDH305 with SOC medications (each Arm)
    Time Frame
    36 months
    Title
    Maximum Plasma Concentration (Cmax)
    Description
    To characterize the PK profile of IDH305 with SOC medications (each Arm)
    Time Frame
    36 months
    Title
    Time taken to reach maximum plasma concentration (Tmax)
    Description
    To characterize the PK profile of IDH305 with SOC medications (each Arm)
    Time Frame
    36 months
    Title
    Complete remission rate (CRR)
    Description
    To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)
    Time Frame
    36 months
    Title
    Overall response rate (ORR)
    Description
    To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)
    Time Frame
    36 months
    Title
    Event free survival (EFS)
    Description
    To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)
    Time Frame
    36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: -- Previously untreated AML. Patients with untreated, high or very high risk MDS (according to rIPSS or equivalent) are also permitted in Arm 2. Documentation of IDH1R132 mutation of tumor ECOG performance status ≤ 2 Clinically fit for standard of care medication per protocol. Exclusion Criteria: Prior treatment for AML or MDS Any severe or uncontrolled medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease. Acute Promyelocytic Leukemia Women who are pregnant or lactating Other protocol-defined Inclusion/Exclusion may apply
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia

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