Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT03317366
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
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT03317366
Study Brief:
Protocol Section:
NCT03317366