Status:

NO_LONGER_AVAILABLE

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

Lead Sponsor:

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

Conditions:

Proteus Syndrome

PIK3CA-Related Overgrowth Spectrum (PROS)

Eligibility:

All Genders

2+ years

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT03317366

Last Update

August 6 2021

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