AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
H. Lee Moffitt Cancer Center and Research Institute
Amgen
Information provided by (Responsible Party):
Matthew H. Kulke, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01024387
First received: December 1, 2009
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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 teh 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.


Condition Intervention Phase
Neuroendocrine Tumor
Carcinoid Tumor
Pancreatic Neuroendocrine Tumor
Drug: AMG 479
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Institutional, Phase II Open-Label Study of AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the objective response rate associated with AMG 479 in patients with advanced carcinoid or pancreatic neuroendocrine tumors. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the duration of response associated with AMG 479 in this patient population. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • To determine the safety and tolerability of AMG 479 in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To determine the progression free survival and overall survival of carcinoid or pancreatic neuroendocrine tumor patients receiving AMG 479. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AMG 479
    Given intravenously once every three weeks
Detailed Description:
  • Participants will receive treatment with AMG 479 once every three weeks (1 cycle is 3 weeks). AMG 479 is given by intravenous infusion.
  • At the beginning of every cycle, participants will have the following procedures: medical history, physical exam, blood tests and an electrocardiogram (EKG).
  • Following every 3 cycles, participants will have the following procedures: blood tests, an assessment of the tumor by CT scan or MRI and 24-hour urine sample (if applicable).
  • Participants may remain in the research study as long as their doctor determines that they are showing evidence of clinical benefit from the treatment.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024387

Locations
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
H. Lee Moffitt Cancer Center and Research Institute
Amgen
Investigators
Principal Investigator: Matthew Kulke, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Matthew H. Kulke, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01024387     History of Changes
Other Study ID Numbers: 09-240
Study First Received: December 1, 2009
Last Updated: May 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
AMG 479

Additional relevant MeSH terms:
Neoplasms
Neuroendocrine Tumors
Carcinoid Tumor
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
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

ClinicalTrials.gov processed this record on September 18, 2014