Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the G… (NCT05997056) | Clinical Trial Compass
RecruitingPhase 2
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
United States21 participantsStarted 2023-11-07
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Patients with functional NETs may enroll if:
✓. the patient has been on a stable dose of an somatostatin analogs for ≥12 weeks and
✓. the patient has experienced disease progression while on stable somatostatin analogs dose
✓. Patients must have 1 or more measurable target lesions by RECIST v1.1
✓. Age: 18 years or older
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or Karnofsky Performance Status (KPS) ≥80
✓. Adequate liver function:
Exclusion criteria
✕. Prior treatment with mTOR inhibitors including nab-sirolimus
✕. Patients with functional NETs who are experiencing uncontrolled symptoms attributed to hormones and other vasoactive substances secreted by the tumor
✕. Patients with inactivating TSC1 or TSC2 alterations (based on tissue or liquid NGS)
✕. Severe (Grade ≥3) ongoing infection requiring parenteral or oral anti-infective treatment, either ongoing or completed ≤7 days prior to enrollment
✕. Patients who have any severe and/or uncontrolled medical or psychiatric conditions or other conditions that could affect their participation including:
✕. Known or suspected brain metastases
✕. Severe heart disease defined as unstable angina pectoris, NYHA Class III or IV congestive heart failure, myocardial infarction ≤6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease.
✕. Severe lung disease defined as a diffusing capacity for carbon monoxide that is ≤50% of normal predicted value and/or an O2 saturation ≤88% at rest on room air