Carfilzomib for the Treatment of Patients With Advanced Neuroendocrine Cancers

Completed · Phase 2

Conditions studied: Neuroendocrine Cancer

In brief

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

Key facts

Study ID

NCT02318784

Run by

SCRI Development Innovations, LLC

People needed

62

Starts

2015-07-15

Expected to finish

2021-05-15

Last updated by the study team

2023-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Measurable disease per Response Evaluation Criteria in Solid Tumors RECIST v 1.1 criteria.
• 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.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• Adequate hematologic, renal, and hepatic function.
• Predicted life expectancy > 12 weeks.

You may not qualify if…

• 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.
• 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.
• 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.
• Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
• 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.
• Known diagnosis of human immunodeficiency virus, hepatitis B or hepatitis C.

Where it is running

• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Florida Cancer Specialists - North — St. Petersburg, Florida, United States
• Ingalls Cancer Research Center — Harvey, Illinois, United States
• Research Medical Center — Kansas City, Missouri, United States
• Oncology Hematology Care, INC. — Cincinnati, Ohio, United States
• Spartanburg Regional Medical Center/Gibbs Cancer Center — Spartanburg, South Carolina, United States
• Tennessee Oncology PLLC — Nashville, Tennessee, United States
• Center for Cancer and Blood Disorders — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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