Study on Nab-sirolimus for Patients with Neuroendocrine Tumors of the Gastrointestinal Tract, Lung, or Pancreas

Inclusion Criteria

• Have well-differentiated neuroendocrine tumors (NETs) of the gastrointestinal tract, lung, or pancreas that are advanced and cannot be surgically removed or have spread.
• Have received two or fewer previous treatments, not counting somatostatin analogs.
• For patients with functional NETs, must have been on a stable dose of somatostatin analogs for at least 12 weeks and have shown disease progression during this time.
• Have at least one measurable tumor.
• Be 18 years or older.
• Be in good general health with a performance status score of 0 or 1.
• Have adequate liver and kidney function as shown by specific blood tests.
• Have adequate blood cell counts.
• Have controlled cholesterol and triglyceride levels.
• Have recovered from any previous treatments or surgeries.
• Agree to use effective birth control methods if of childbearing potential.
• Understand and sign the informed consent form.
• Be willing to comply with study visits and procedures.
• Patients with HIV are eligible if they have no recent opportunistic infections, are on stable antiretroviral therapy, and have a low viral load.

Exclusion Criteria

• Have previously been treated with mTOR inhibitors, including nab-sirolimus.
• Have uncontrolled symptoms from functional NETs.
• Have specific genetic alterations (TSC1 or TSC2) in the tumor.
• Have a severe ongoing infection requiring treatment.
• Have severe or uncontrolled medical or psychiatric conditions, including:
  • Known or suspected brain metastases.
  • Severe heart disease or recent heart attack.
  • Severe lung disease or low oxygen levels.
  • Uncontrolled high blood pressure.
  • History of certain lung diseases or pulmonary hypertension.
  • Active Hepatitis B or C infection.
• Require medications that strongly interact with the study drug.