CompletedPhase 2

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

United States34 participantsStarted 2015-10

Plain-language summary

A phase 2 multi-center investigation of efficacy of nab-sirolimus (formerly known as ABI-009 or nab-rapamycin) in patients with advanced malignant perivascular epithelioid cell tumor (PEComa).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients must have a histologically confirmed diagnosis of malignant PEComa that is either metastatic or locally advanced and for which surgery is not a recommended option.
✓. Patients must have available tumor block along with the corresponding pathology report (or approximately 30 unstained slides, with a minimum of 16 slides), and/or fresh biopsy to allow retrospective centralized confirmation of malignant PEComa and for mTOR pathway analysis and biomarker analysis.
✓. Patients must have one or more measurable target lesions by CT scan or MRI. Measurable disease by RECIST v1.1.
✓. Patients must not have been previously treated with an mTOR inhibitor.
✓. Prior treatment (investigational or other), chemotherapy, radiotherapy, surgery, or other therapeutic agents (except mTOR inhibitors) is allowed, if completed after 5 half-lives or ≥28 days prior to enrollment, whichever is shorter.
✓. Eligible patients, 18 years or older, with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
✓. Patients must have the following blood chemistry levels at screening (obtained
✓. total bilirubin ≤1.5 x upper limit of normal (ULN) mg/dl

Exclusion criteria

✕. Patients with lymphangioleiomyomatosis (LAM) are excluded.
✕. 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.
✕. Active gastrointestinal bleeding, if transfusion dependent.
✕. Pre-existing thyroid abnormality is allowed provided thyroid function can be controlled with medication.
✕. 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).
✕. 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.
✕. Recent infection requiring systemic anti-infective treatment that was completed
✕. Uncontrolled diabetes mellitus as defined by HbA1c \>8% despite adequate therapy.

What they're measuring

Objective Overall Response Rate (ORR)

Timeframe: through study completion (up to 72 months)

Trial details

NCT IDNCT02494570

SponsorAadi Bioscience, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-11

Results submitted2022-12-12

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