Clinical trial · Interventional
AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors
A Phase II Clinical and Biologic Study of AMG 706 and Octreotide in Patients With Low-Grade Neuroendocrine Tumors
NCT00427349CI-TRIAL-00067799completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: AMG 706 and octreotide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well AMG 706 and octreotide work in treating patients with low-grade neuroendocrine tumors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Carcinoid Tumor | Digestive System Neuroendocrine Tumor G1 | ALIAS | 0.90 |
| Islet Cell Tumor | Pancreatic Neuroendocrine Tumor | ALIAS | 0.90 |
| Neoplastic Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 706 | Drug | Motesanib | ALIAS |
| octreotide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AMG 706+Octreotide
- description
- Patients receive oral AMG 706 and octreotide acetate intramuscularly (IM) once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the morning. AMG 706 was taken daily without breaks in treatment. One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles.
- interventionNames
- Drug: AMG 706
- Drug: octreotide
Primary outcomes (1)
- measure
- Four-month Progression-free Survival Rate
- timeFrame
- assessed every 4 weeks while on treatment and at three months post-treatment for participants treated for one cycle, up to month four
- description
- Four-month progression-free survival (PFS) rate is defined as number of patients who are still progression free at 4 months after study entry divided by number of eligible and treated patients enrolled to the study. Progression is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), or unequivocal progression of existing non-target lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed low-grade neuroendocrine neoplasm * Measurable disease * Radiographic evidence of disease progression after any prior systemic therapy, chemoembolization, bland embolization, or observation, defined by either of the following: * Appearance of a new lesion * At least 20% increase in the longest diameter of any previously documented lesion or in the sum of the longest diameters of multiple lesions * Tissue block from original diagnostic or surgical specimen required * Concurrent stable-dose octreotide acetate required * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Negative pregnancy test * Fertile patients must use effective contraception * Must be able to receive a contrast-enhanced CT scan * Absolute neutrophil count ≥ 1,000/mm³ * Platelet count ≥ 75,000/mm³ * Hemoglobin level ≥ 8.0 g/dL * Bilirubin ≤ 2.0 times upper limit of normal (ULN) * Aspartate aminotransferase (AST) ≤ 3 times ULN (5 times ULN if liver metastases are present) * Left Ventricular Ejection Fraction (LVEF) ≥ institutional lower limit of normal as evaluated by echocardiography or multigated acquisition (MUGA) scan * No history of uncontrolled hypertension (resting blood pressure \> 150/90 mm Hg) * Antihypertensive medications allowed if patients is stable on their current dose * One prior systemic chemotherapy regimen for low-grade neuroendocrine neoplasm allowed * Chemoembolization is not considered systemic chemotherapy * At least 4 weeks since prior major surgery, chemotherapy, radiation therapy, other systemic therapy, or local liver therapy Exclusion criteria: * Prior procedures that would adversely affect intestinal absorption * Prior anti-vascular endothelial growth factors * Concurrent chemotherapy or radiation therapy * History of the following within the past 12 months: * New York Heart Association class III or IV congestive heart failure * Unstable angina pectoris * Myocardial infarction * Symptomatic cardiac arrhythmia * Cerebrovascular accident or transient ischemic attack * Arterial or venous thrombosis * Known history of allergic reactions to AMG 706 or derivatives or to octreotide acetate injections * Gastrointestinal tract disease resulting in an inability to take oral medication (i.e., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea, bowel obstruction, or inability to swallow tablets) * Pregnant or nursing * Small cell lung cancer, medullary thyroid cancer, paraganglioma, or pheochromocytoma * Requirement for intravenous alimentation
References
Publications (1)
- DERIVEDLubner S, Feng Y, Mulcahy M, O'Dwyer P, Giang GY, Hinshaw JL, Deming D, Klein L, Teitelbaum U, Payne J, Engstrom P, Stella P, Meropol N, Benson A. E4206: AMG 706 and Octreotide in Patients with Low-Grade Neuroendocrine Tumors. Oncologist. 2018 Sep;23(9):1006-e104. doi: 10.1634/theoncologist.2018-0294. Epub 2018 May 31. PMID 29853660