A Phase 2 Multi-center, Open-label, Single Arm Study of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors
Aadi Bioscience, Inc.
Summary
A Phase 2 multi-center, open-label, single arm study of nab-sirolimus in patients with well-differentiated neuroendocrine tumors (NETs) of the gastrointestinal tract, lung, or pancreas who have not received prior treatment with mTOR inhibitors
Description
This is a prospective phase 2 single arm, open-label, multi-institutional study to determine the efficacy and safety prospective of nab-sirolimus and patients with functional or non-functional, well-differentiated, locally advanced unresectable in metastatic NETs of the GI tract, lung, or pancreas.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with functional or non-functional, well-differentiated, locally advanced unresectable or metastatic NETs of the GI tract, lung, or pancreas who have received 2 or less prior lines of therapy excluding somatostatin analogs 2. Patients with functional NETs may enroll if: 1. the patient has been on a stable dose of an somatostatin analogs for ≥12 weeks and 2. the patient has experienced disease progression while on stable somatostatin analogs dose 3. Patients must have 1 or more measurable target lesions by RECIST v1.1 4. Age: 18 years or older 5. Eastern C…
Interventions
- Drugnab-sirolimus
Prospective phase 2 single arm, open-label, multi-institutional study to determine the efficacy and safety prospective of nab-sirolimus administered by IV infusion
Locations (4)
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- Rocky Mountain Cancer CentersDenver, Colorado
- Texas OncologyDallas, Texas
- Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin