Carfilzomib for the Treatment of Patients With Advanced Neuroendocrine Cancers

NCT02318784 | Completed Phase 2 Results

• 1 other identifier: SCRI GI 195
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Neuroendocrine Cancer

Keywords

neuroendocrine malignancies; pancreatic neuroendocrine tumors (PNETs); gastrointestinal (GI) carcinoids; carfilzomib; Kyprolis; proteasome inhibitors

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Percentage of participants with confirmed complete response (CR) or partial response (PR) (i.e. 2 CRs or PRs at least 4 weeks apart) to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) CR=disappearance of all target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  every 3 cycles (1 cycle= 28 days) until treatment discontinuation up to 4 years

Secondary Outcomes (3)

• Disease Control Rate (DCR)

  every 3 cycles (1 cycle= 28 days) until treatment discontinuation up to 4 years

• Progression Free Survival (PFS)

  up to 4 years

• Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability

  From the day of the first dose to 30 days after the last dose of study medication, up to 4 years

Study Arms (1)

Carfilzomib

EXPERIMENTAL

Carfilzomib will be administered as intravenous (IV) infusion over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of each 28-day cycle. Cycle 1: First two doses of Carfilzomib 20 mg/m2 IV; subsequent doses at 56 mg/m2 IV Cycle 2 onwards: Carfilzomib 56 mg/m2 IV

Drug: Carfilzomib

Interventions

Carfilzomib DRUG

Also known as: Kyprolis

Carfilzomib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Amgen: collaborator

Study Sites (10)

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33916, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Florida Cancer Specialists - North

St. Petersburg, Florida, 33705, United States

Location

Ingalls Cancer Research Center

Harvey, Illinois, 60426, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Oncology Hematology Care, INC.

Cincinnati, Ohio, 45219, United States

Location

Spartanburg Regional Medical Center/Gibbs Cancer Center

Spartanburg, South Carolina, 29303, United States

Location

Tennessee Oncology PLLC

Nashville, Tennessee, 37203, United States

Location

Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Carcinoma, Neuroendocrine; Carcinoid Tumor

Interventions

carfilzomib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Sarah Cannon Development Innovations, LLC
• Organization: Sarah Cannon Development Innovations, LLC

CANN.InnovationsMedical@sarahcannon.com

844-710-6157

Study Officials

• David Spigel, M.D.

  SCRI Development Innovations, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: December 17, 2014
• Study Start: July 15, 2015
• Primary Completion: May 15, 2021
• Study Completion: May 15, 2021
• Last Updated: December 5, 2023
• Results First Posted: July 1, 2022

Record last verified: 2022-06

Locations

US (10)