AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors

NCT01024387 | Completed Phase 2 Results DMC

• 1 other identifier: 09-240
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Neuroendocrine Tumor; Carcinoid Tumor; Pancreatic Neuroendocrine Tumor

Keywords

AMG 479

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Objective response rate is the percentage of patients achieving partial response (PR) or complete response (CR) per RECIST 1.0 criteria. For target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR status must be confirmed by repeat assessments performed no fewer than 4 weeks or more than 6 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

  Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks).

Secondary Outcomes (4)

• Duration of Response

  Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks).

• Grade 3-4 Toxicity Rate

  Toxicity was evaluated every cycle (3 weeks) on treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks).

• Progression Free Survival

  Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort were followed up to 20 months.

• 1-Year Overall Survival

  Patients in this study cohort were followed up to 20 months.

Study Arms (1)

AMG 479

EXPERIMENTAL

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.

Drug: AMG 479

Interventions

AMG 479 DRUG

Also known as: ganitumab

AMG 479

Eligibility Criteria

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

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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 \[insulin like growth factor \]

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator
• Amgen: collaborator

Study Sites (3)

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 23572164 BACKGROUND

MeSH Terms

Conditions

Neuroendocrine Tumors; Carcinoid Tumor; Adenoma, Islet Cell

Interventions

ganitumab

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Adenoma; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Matthew H. Kulke, MD
• Organization: Dana-Farber Cancer Institute

Matthew_Kulke@dfci.harvard.edu

617.632.5136

Study Officials

• Matthew Kulke, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: March 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: March 8, 2018
• Results First Posted: December 27, 2017

Record last verified: 2018-02

Locations

US (3)