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Expanded Access to Provide ARQ 092 for the Treatment of Overgrowth Diseases and/or Vascular Anomalies

Primary Purpose

Proteus Syndrome, PIK3CA-Related Overgrowth Spectrum (PROS), Growth Disorders

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
ARQ 092
Sponsored by
ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Proteus Syndrome focused on measuring ARQ 092, ArQule, AKT, PIK3CA, Overgrowth, Congenital malformations

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  1. Severe overgrowth diseases and/or vascular anomalies with confirmed somatic genetic alterations of PIK3CA or AKT
  2. Are unable to participate in an ongoing ARQ 092 clinical trial
  3. Willing and able to provide written, signed informed consent. In the case of a minor, a parent or legal guardian must sign an informed consent form.
  4. Medically suitable for treatment with ARQ 092
  5. Not eligible for any other available therapy for the diagnosed overgrowth disease and/or vascular anomaly with confirmed somatic genetic alterations of PIK3CA or AKT

Exclusion Criteria:

  1. Currently enrolled in an ongoing clinical study of ARQ 092 or other investigational drug
  2. Currently being treated with any inhibitor of the PI3K/AKT/mTOR pathway

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 17, 2017
    Last Updated
    July 31, 2021
    Sponsor
    ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03317366
    Brief Title
    Expanded Access to Provide ARQ 092 for the Treatment of Overgrowth Diseases and/or Vascular Anomalies
    Official Title
    Expanded Access to Provide ARQ 092 for the Treatment of Overgrowth Diseases and/or Vascular Anomalies With Genetic Alterations of the PI3K/AKT Pathway
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

    4. Oversight

    5. Study Description

    Brief Summary
    ARQ 092 is being investigated for patients with overgrowth diseases and/or vascular anomalies with genetic alterations of the PI3K/AKT pathway and may be available for patients who are ineligible for an ongoing ARQ 092 clinical trial or have other considerations that prevent access to ARQ 092 through an existing clinical trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Proteus Syndrome, PIK3CA-Related Overgrowth Spectrum (PROS), Growth Disorders
    Keywords
    ARQ 092, ArQule, AKT, PIK3CA, Overgrowth, Congenital malformations

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ARQ 092
    Intervention Description
    Open-label expanded access for ARQ 092 capsules

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Eligibility Criteria
    Inclusion Criteria: Severe overgrowth diseases and/or vascular anomalies with confirmed somatic genetic alterations of PIK3CA or AKT Are unable to participate in an ongoing ARQ 092 clinical trial Willing and able to provide written, signed informed consent. In the case of a minor, a parent or legal guardian must sign an informed consent form. Medically suitable for treatment with ARQ 092 Not eligible for any other available therapy for the diagnosed overgrowth disease and/or vascular anomaly with confirmed somatic genetic alterations of PIK3CA or AKT Exclusion Criteria: Currently enrolled in an ongoing clinical study of ARQ 092 or other investigational drug Currently being treated with any inhibitor of the PI3K/AKT/mTOR pathway

    12. IPD Sharing Statement

    Learn more about this trial

    Expanded Access to Provide ARQ 092 for the Treatment of Overgrowth Diseases and/or Vascular Anomalies

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