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

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