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