FindTrial
Sign In

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 With Genetic Alterations of the PI3K/AKT Pathway

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03317366
Enrollment
Unknown
Registered
2017-10-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

ARQ 092, ArQule, AKT, PIK3CA, Overgrowth, Congenital malformations

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.

Interventions

DRUGARQ 092

Open-label expanded access for ARQ 092 capsules

Sponsors

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

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026