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

NCT ID: NCT03317366

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

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

Interventions

ARQ 092

Open-label expanded access for ARQ 092 capsules

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ARQ 092 Expanded Access

Identifier Type: -

Identifier Source: org_study_id