Status:
NO_LONGER_AVAILABLE
Expanded Access to Provide ARQ 092 for the Treatment of Overgrowth Diseases and/or Vascular Anomalies
Lead Sponsor:
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Conditions:
Proteus Syndrome
PIK3CA-Related Overgrowth Spectrum (PROS)
Eligibility:
All Genders
2+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03317366
Last Update
August 6 2021
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