AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors

NCT ID: NCT01024387

Last Updated: 2018-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2017-01-31

Brief Summary

The purpose of this research study is to determine the effectiveness of AMG 479 against carcinoid and pancreatic neuroendocrine tumors. AMG 479 is an antibody that is made in the laboratory. Antibodies are highly specific proteins produced by the body's immune system that recognize foreign substances in the body. AMG 479 has been used in other research studies and information from those other research studies suggests that AMG 479 may help to prevent the growth of some neuroendocrine tumors. The observed antitumor activity of AMG 479, together with the current limited treatment options available for patients with neuroendocrine tumors, warrant further investigation of AMG 479 in this patient population.

Detailed Description

Neuroendocrine tumors (NETs) comprise a heterogeneous spectrum of neoplasms. NETs are commonly subclassified into two broad subgroups according to their site of origin: pancreatic NETs are thought to arise from the endocrine cells of the pancreas, whereas NETs of other sites such as the lungs or gastrointestinal tract are often referred to as carcinoid tumors. While histologically similar, carcinoid tumors and pancreatic neuroendocrine tumors have demonstrated different response rates in prior phase II studies of antitumor agents. Because of these differences, we will perform the current study using two cohorts of patients (30 with carcinoid and 30 with pancreatic neuroendocrine tumors). The statistical design, however, is the same for both cohorts. With 30 patients in each cohort, this study has 80% power assuming type I error of 6% to differentiate a >/=17% objective response rate from a </=5% objective response rate using a single stage design. The proposed regimen would be promising in either cohort if at least 4 of 30 patients achieve an objective response.

Conditions

Neuroendocrine Tumor; Carcinoid Tumor; Pancreatic Neuroendocrine Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AMG 479

Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.

Group Type: EXPERIMENTAL

AMG 479

Intervention Type: DRUG

Interventions

AMG 479

Intervention Type: DRUG

Other Intervention Names

ganitumab

Eligibility Criteria

Inclusion Criteria

• Locally unresectable or metastatic carcinoid or pancreatic neuroendocrine tumors. To be classified as having a pancreatic neuroendocrine tumor, patients must have clinical evidence of currently having or having had a primary pancreatic neuroendocrine lesion.
• Measurable disease by RECIST criteria
• Evidence of progressive disease (by RECIST) within 12 months of study entry.
• Tumors must be considered well- or moderately-differentiated. Patients with poorly differentiated neuroendocrine carcinoma of small cell carcinoma are excluded from this study.
• Adequate hepatic, renal, bone marrow and glycemic function as outlined in the protocol
• Prior treatment with chemotherapy, hepatic artery embolization, surgery or other therapeutic agents is allowed.
• Prior or concurrent therapy with somatostatin analogs is permitted: however patients must continue on a stable dose of somatostatin analogs while receiving study treatment.
• 18 years of age or older
• ECOG performance status 0, 1, or 2 [Eastern Cooperative Oncology Group ]
• Life expectancy of at least 12 weeks
• Negative pregnancy test
• Ability to sign informed consent

Exclusion Criteria

• Poorly differentiated or small cell neuroendocrine carcinomas
• Insulin secreting pancreatic neuroendocrine tumors (insulinomas)
• Clinically apparent central nervous system metastases or carcinomatous meningitis.
• Myocardial infraction in the past 6 months
• Major surgery 4 weeks prior to enrollment
• Uncontrolled serious medical or psychiatric illness
• Pregnant or lactating women. Both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study.
• Prior antitumor therapy within 4 weeks of enrollment (with the exception of somatostatin analogs).
• Recent infection requiring systemic anti-infective treatment that was completed 14 days or less prior to enrollment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection).
• Known positive test for human immunodeficiency virus, hepatitis C, chronic or active hepatitis B
• Prior IGF or IGF receptor inhibitor therapy [insulin like growth factor ]

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: collaborator

Amgen

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Matthew H. Kulke, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Kulke, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

Strosberg JR, Chan JA, Ryan DP, Meyerhardt JA, Fuchs CS, Abrams T, Regan E, Brady R, Weber J, Campos T, Kvols LK, Kulke MH. A multi-institutional, phase II open-label study of ganitumab (AMG 479) in advanced carcinoid and pancreatic neuroendocrine tumors. Endocr Relat Cancer. 2013 May 21;20(3):383-90. doi: 10.1530/ERC-12-0390. Print 2013 Jun.

Reference Type: BACKGROUND

PMID: 23572164 (View on PubMed)

Other Identifiers

09-240

Identifier Type: -

Identifier Source: org_study_id