Clinical Trials /

A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations

NCT02381886

Description:

A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.

Related Conditions:
  • Cancer
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 <span class="go-doc-concept go-doc-keyword">Mutations</span>

Title

  • Brief Title: A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations
  • Official Title: A Phase I Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations
  • Clinical Trial IDs

    NCT ID: NCT02381886

    ORG ID: CIDH305X2101

    Trial Conditions

    Advanced Malignancies That Harbor IDHR132 Mutations

    Trial Interventions

    Drug Synonyms Arms
    IDH305 IDH305

    Trial Purpose

    A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132
    mutations.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    IDH305 Experimental IDH305

    Eligibility Criteria

    Inclusion Criteria:

    - Documented IDH1R132-mutant tumors

    - Disease that has progressed since last prior therapy and for which there is no
    curative therapy

    - ECOG performance status 2

    Exclusion Criteria:

    - Patients who have received prior treatment with a mutant-specific IDH1 inhibitor
    (with the exception of glioma patients)

    - 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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Incident rate of dose limiting toxicities (DLTs)

    Secondary Outcome Measures

    Incidence of adverse events (AEs)

    Plasma PK parameters (AUC, Cmax, Tmax)

    Changes of 2-hydroxyglutarate concentration in patient specimens

    Overall response rate (ORR)

    Incidence of serious adverse events (SAE)

    Trial Keywords

    Advanced malignancies,

    IDHR132 mutations,

    IDH305

    IDH