A Phase 2 Study of Nab-sirolimus (ABI-009) in Patients With Advanced Malignant PEComa

Exclusion Criteria

• •A patient will not be eligible for inclusion in this study if any of the following criteria apply:
• •1. Patients with lymphangioleiomyomatosis (LAM) are excluded.
• •2. Known active uncontrolled or symptomatic central nervous system (CNS) metastases. A patient with controlled and asymptomatic CNS metastases may participate in this study. As such, the patient must have completed any prior treatment for CNS metastases ≥28 days (including radiotherapy and/or surgery) prior to start of treatment in this study and should not be receiving chronic corticosteroid therapy for the CNS metastases.
• •3. Active gastrointestinal bleeding, if transfusion dependent.
• •4. Pre-existing thyroid abnormality is allowed provided thyroid function can be controlled with medication.
• •5. Uncontrolled serious medical or psychiatric illness. Patients with a "currently active" second malignancy other than non-melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer (staged pT2 with Gleason Score ≤ 6 and postoperative PSA \<0.5 ng/mL), or other adequately treated carcinoma-in-situ are ineligible. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥1 year).
• •6. Liver-directed therapy within 2 months of enrollment. Prior treatment with radiotherapy (including radio-labeled spheres and/or cyberknife, hepatic arterial embolization (with or without chemotherapy) or cyrotherapy/ablation) is allowed if these therapies did not affect the areas of measurable disease being used for this protocol.
• •7. Recent infection requiring systemic anti-infective treatment that was completed
• •≤14 days prior to enrollment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection).
• •8. Uncontrolled diabetes mellitus as defined by HbA1c \>8% despite adequate therapy.
• •9. Unstable coronary artery disease or myocardial infarction during preceding 6 months.
• •10. Receiving any concomitant antitumor therapy.
• •11. Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
• •12. The use of certain medications and illicit drugs within 5 half-lives or 28 days, whichever is shorter prior to the first dose of study drug and for the duration of the study will not be allowed.
• •13. Use of strong inhibitors and inducers of CYP3A4 within the 14 days prior to receiving the first dose of ABI-009. Additionally, use of any known CYP3A4 substrates with narrow therapeutic window (such as fentanyl, alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, terfanide) within the 14 days prior to receiving the first dose of ABI-009.