AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors
Condition: Neuroendocrine Tumor; Carcinoid Tumor; Pancreatic Neuroendocrine Tumor
MeSH terms: Neoplasms; Neuroendocrine Tumors; Carcinoid Tumor; Adenoma, Islet Cell
Intervention: AMG 479
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AMG 479

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.
    

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 ]