Nab-Sirolimus for Neuroendocrine Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests nab-sirolimus, a drug that targets tumors, in patients with advanced neuroendocrine tumors of the GI tract, lung, or pancreas. The drug works by blocking a protein that helps tumor cells grow and survive. Nab-sirolimus is the first agent specifically approved for advanced unresectable or metastatic malignant PEComa.
Do I need to stop my current medications for the trial?
The trial requires you to stop taking medications that strongly interact with CYP3A4 enzymes, such as certain antibiotics and antifungals, before starting the study. If you're on these medications, you'll need to discontinue them before your first dose of nab-sirolimus.
Is nab-sirolimus safe for humans?
A study on nab-rapamycin (another name for nab-sirolimus) in patients with advanced cancers found it was generally safe, but determining the maximum safe dose was a key focus. Everolimus, a similar drug, has been linked to rare lung inflammation, which suggests monitoring for similar side effects might be important with nab-sirolimus.12345
What makes nab-sirolimus unique for treating neuroendocrine tumors?
What data supports the effectiveness of the drug nab-sirolimus for neuroendocrine tumors?
Who Is on the Research Team?
Willis Navarro, MD
Principal Investigator
Aadi Bioscience
Are You a Good Fit for This Trial?
This trial is for adults with well-differentiated neuroendocrine tumors in the GI tract, lung, or pancreas. They should not have had prior mTOR inhibitor treatment and can have up to two other therapies (excluding somatostatin analogs). Participants need functioning major organs, controlled HIV if present, no severe medical conditions or recent surgeries, and must use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nab-sirolimus for the treatment of well-differentiated neuroendocrine tumors
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- nab-sirolimus
nab-sirolimus is already approved in United States for the following indications:
- Advanced malignant perivascular epithelioid cell tumors (PEComa)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aadi Bioscience, Inc.
Lead Sponsor