Carfilzomib for the Treatment of Patients With Advanced Neuroendocrine Cancers
Condition: Neuroendocrine Cancer
MeSH terms: Carcinoma, Neuroendocrine
Intervention: Carfilzomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neuroendocrine malignancies; pancreatic neuroendocrine tumors (PNETs); gastrointestinal (GI) carcinoids; carfilzomib; Kyprolis; proteasome inhibitors

Summary:

      The purpose of this study is to determine if carfilzomib is safe and effective in the
      treatment of patients with advanced neuroendocrine tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults with biopsy-proven advanced, unresectable or metastatic, well-to-moderately
             differentiated (or low grade) neuroendocrine carcinoma, including typical carcinoid,
             pancreatic islet cell and other well-to-moderately differentiated neuroendocrine
             carcinomas.

          2. Measurable disease per Response Evaluation Criteria in Solid Tumors RECIST v 1.1
             criteria.

          3. Patients currently receiving or previously treated with single agent sandostatin LAR®
             are eligible. However, this is not a mandatory criterion to be included in the study.

          4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

          5. Adequate hematologic, renal, and hepatic function.

          6. Predicted life expectancy > 12 weeks.

        Exclusion Criteria:

          1. Patients with poorly differentiated neuroendocrine carcinoma, high-grade
             neuroendocrine carcinoma, adenocarcinoid, globlet cell carcinoid, atypical carcinoid,
             anaplastic carcinoid, pulmonary neuroendocrine and small cell carcinoma are not
             eligible.

          2. Patients who had radiation therapy, hormonal therapy, biologic therapy,
             investigational agents, or chemotherapy for cancer within 21 days or 5 half-lives of
             any chemotherapy or biologic/targeted agent, whichever is longer, prior to first
             treatment day of the study.

          3. Concurrent severe, intercurrent illness including, but not limited to, ongoing or
             active infection, or psychiatric illness/social situations that would impair the
             ability of the patient to receive protocol treatment.

          4. Major surgical procedures ≤28 days of beginning study drug, or minor surgical
             procedures ≤7 days. No waiting required following port-a-cath placement.

          5. Previously untreated brain metastases. Patients who have received radiation or surgery
             for brain metastases are eligible if therapy was completed at least 2 weeks prior to
             study entry and there is no evidence of central nervous system disease progression,
             mild neurologic symptoms, and no requirement for chronic corticosteroid therapy.

          6. Known diagnosis of human immunodeficiency virus, hepatitis B or hepatitis C.