Expanded Access for ABI-009 in Patients with Advanced PEComa and Other Cancers with Specific Genetic Mutations

Sponsor: Aadi Bioscience, Inc.

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03817515

Provider View

This program offers access to a treatment called ABI-009 for patients with advanced PEComa or other cancers that have specific genetic mutations or activate the mTOR pathway, especially when no other treatments are available.

Patient Parameters

Program Overview

This program provides access to ABI-009, a treatment for patients with advanced Perivascular Epithelioid Cell Tumors (PEComa) or other cancers that have certain genetic mutations or activate the mTOR pathway. It is intended for patients who have no other treatment options available.

Description

This program allows patients with advanced PEComa or other cancers with specific genetic mutations or mTOR pathway activation to access ABI-009 treatment. It is designed for those who have no other FDA-approved treatments or satisfactory alternatives available. Patients must meet certain health criteria and agree to use effective contraception if they are of childbearing potential. The program requires patients to understand and sign an informed consent form.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced PEComa or another cancer with mTOR pathway activation or specific genetic mutations, with no other treatment options.
  • Aged 18 or older, with a performance status score of 0, 1, or 2.
  • Acceptable blood chemistry levels, including:
    • Total bilirubin ≤1.5 times the normal limit
    • AST ≤2.5 times the normal limit (or ≤5 times if due to liver metastases)
    • Serum creatinine ≤1.5 times the normal limit
  • Adequate blood counts, including:
    • Neutrophil count ≥1.5 × 10^9/L
    • Platelet count ≥100,000/mm^3
    • Hemoglobin ≥8 g/dL
  • Fasting triglycerides <300 mg/dL and cholesterol <350 mg/dL
  • Males or non-pregnant, non-breastfeeding females, with effective contraception if of childbearing potential
  • Ability to understand and sign informed consent

Exclusion Criteria

  • Uncontrolled serious medical or psychiatric illness
  • Currently active second malignancy, except for certain non-threatening cancers
  • In the physician's opinion, the risks of ABI-009 outweigh the benefits
  • Previous treatment with ABI-009

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