Actively Recruiting
Trial 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
Led by Aadi Bioscience, Inc. · Updated on 2024-07-16
21
Participants Needed
4
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Trial 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Functional or non-functional, well-differentiated, locally advanced unresectable or metastatic NETs of the GI tract, lung, or pancreas with 2 or fewer prior therapies excluding somatostatin analogs
- Functional NET patients on stable somatostatin analog dose for at least 12 weeks with disease progression
- At least one measurable target lesion by RECIST v1.1
- Age 18 years or older
- ECOG performance status 0 or 1 or Karnofsky Performance Status 80 or higher
- Adequate liver function with specified bilirubin and liver enzyme limits
- Adequate kidney function with creatinine clearance of 30 mL/min or higher
- Adequate blood counts allowing transfusions or growth factors
- Fasting serum triglycerides 300 mg/dL or less and cholesterol 350 mg/dL or less
- At least 4 weeks since major surgery, radiation, or prior therapy recovery
- Male or non-pregnant, non-breastfeeding female with agreed contraception or abstinence
- Signed informed consent
- Willingness and ability to comply with study visits and tests
- HIV-positive patients eligible if stable on antiretroviral therapy without strong CYP3A4 interactions and no recent AIDS-defining infections
You will not qualify if you...
- Prior treatment with mTOR inhibitors including nab-sirolimus
- Uncontrolled symptoms from functional NET hormone secretion
- Inactivating TSC1 or TSC2 genetic alterations
- Severe ongoing infection requiring recent treatment
- Severe or uncontrolled medical or psychiatric conditions including brain metastases and severe heart or lung disease
- Uncontrolled hypertension
- History of interstitial lung disease, pneumonitis, or pulmonary hypertension
- Active Hepatitis B or C infection with detectable viral load despite treatment
- Use of medications with strong CYP3A4 interactions that cannot be discontinued before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
2
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
Actively Recruiting
3
Texas Oncology
Dallas, Texas, United States, 75246
Actively Recruiting
4
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
A
Aadi Bioscience Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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