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

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

Status

Conditions: Growth Disorders; PIK3CA-Related Overgrowth Spectrum (PROS); Proteus Syndrome

Treatments: Drug: ARQ 092

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03317366

ARQ 092 Expanded Access

Details and patient eligibility

About

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.

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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