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

Phase 2
18 Years
Open (Enrolling)
Neuroendocrine Tumor, Carcinoid Tumor, Pancreatic Neuroendocrine Tumor

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Trial Information

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

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the objective response rate associated with AMG 479 in patients with advanced carcinoid or pancreatic neuroendocrine tumors.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Matthew Kulke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

March 2010

Completion Date:

Related Keywords:

  • Neuroendocrine Tumor
  • Carcinoid Tumor
  • Pancreatic Neuroendocrine Tumor
  • AMG 479
  • Carcinoid Tumor
  • Neuroendocrine Tumors
  • Adenoma, Islet Cell



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
H. Lee Moffitt Cancer CenterTampa, Florida  33612