AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors

Official Title: “A Multi-Institutional, Phase II Open-Label Study of AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors”

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.

- 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.

Intervention(s) in this Clinical Trial

• Drug: AMG 479
  • Given intravenously once every three weeks

Primary Measures

• To determine the objective response rate associated with AMG 479 in patients with advanced carcinoid or pancreatic neuroendocrine tumors.
  • Time Frame: 2 years
    Safety Issue?: No

Secondary Measures

• To determine the duration of response associated with AMG 479 in this patient population.
  • Time Frame: 4 years
    Safety Issue?: No
• To determine the safety and tolerability of AMG 479 in this patient population.
  • Time Frame: 2 years
    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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Dana-Farber Cancer Institute Other

Overall Clinical Trial Officials and Contacts

Matthew Kulke, MD Principal Investigator Dana-Farber Cancer Institute  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01024387

Study ID Number: 09-240

ClinicalTrials.gov Identifier: NCT01024387

Health Authority: United States: Food and Drug Administration