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

Sponsor

ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) (Industry)

Overall Status

No longer available

CT.gov ID

NCT03317366

Collaborator

(none)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Proteus Syndrome PIK3CA-Related Overgrowth Spectrum (PROS) Growth Disorders	Drug: ARQ 092

Study Design

Study Type:

Expanded Access

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

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