NO_LONGER_AVAILABLENot Applicable

Compassionate Use of BYL 719 Alpelisib

United States

Plain-language summary

This is a compassionate use protocol of BYL719 (alpelisib) treatment for a single patient with locally advanced lymphangioma positive PI3K alpha H1047R mutation.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient has signed the Informed Consent (ICF) prior to any eligibility evaluations being performed and is able to comply with protocol requirements
✓. Patient is an adult and ≥ 18 years old at the time of informed consent
✓. Patient has locally advanced or metastatic cancer resistant or refractory to available standard of care treatment options and has no other available comparable or satisfactory alternative treatment options
✓. PIK3CA mutation, or other molecular alteration known to activate PI3K, in tumor tissue as determined by a standard Laboratory
✓. Patient is not eligible for participation in any ongoing clinical trials with alpelisib, or has recently completed a clinical trial with alpelisib that has been terminated, and after considering other options (e.g. trial extensions, amendments, etc.), the treating physician has determined that treatment is necessary and there are no other feasible alternatives for the patient
✓. Patient is not being transferred from an ongoing clinical trial for which they are still eligible
✓. Patient has adequate bone marrow and organ function as defined by the following laboratory values:
✓. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L

Exclusion criteria

✕. Patient has history of hypersensitivity to any drugs or metabolites of similar chemical classes as alpelisib
✕. Patient has not recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy
✕. Patient has had major surgery within 4 weks prior to starting treatment with alpelisib or has not recovered from major side effects
✕. Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting treatment with alpelisib, or has not fully recovered from side effects of such treatment
✕. Patient with clinically manifest diabetes mellitus, or documented steroid induced diabetes mellitus
✕. Patient is being treated at start of treatment with alpelisib with any of the following drugs:
✕. Patient is currently receiving warfarin or other coumarin derived anti-coagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.
✕. Patients who have other concurrent severe and/or uncontrolled medical conditions that would, in the Treating Physician's judgment, contraindicate patient participation in the individual patient program (eg. active or uncontrolled severe infection, chronic active hepatitis, immuno-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc.)

Trial details

NCT IDNCT03941782

SponsorNew Mexico Cancer Research Alliance

Sponsor typeOTHER

Study typeEXPANDED_ACCESS

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