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Sponsored by: |
ImClone Systems |
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Information provided by: | ImClone Systems |
ClinicalTrials.gov Identifier: | NCT00781911 |
Determine the 6-month progression free survival (PFS) rate associated with IMC-A12 in combination with depot octreotide acetate (octreotide) in patients with metastatic neuroendocrine tumors.
Condition | Intervention | Phase |
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Carcinoma |
Biological: A12 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Multicenter, Two Tier Study of IMC-A12 in Combination With Depot Octreotide in Patients With Metastatic, Well or Moderately Differentiated Carcinoid or Islet Cell Carcinoma |
Estimated Enrollment: | 60 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Patients will receive intravenous (I.V.) IMC-A12 10 mg/kg over 1 hour every 2 weeks. ). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.
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Biological: A12
Patients will receive intravenous (I.V.) IMC-A12 10 mg/kg over 1 hour every 2 weeks. ). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.
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Recent Phase 2 studies have evaluated a variety of targeted therapies in the treatment of metastatic NETs. Available data suggest that therapy targeting the IGF-IR may produce comparable results. A significant proportion of neuroendocrine tumors express IGF and/or the IGF-IR,which may help to regulate cell growth. In BON cancer cell lines derived from human pancreatic carcinoid tumors, the binding of IGF-I to its receptor appears to stimulate PI3K,MAPK, and p70 S6 kinase activity, and thereby to promote tumor cell growth. Hopfner et al have demonstrated that treating BON cells with the IGF-IR inhibitor NVP-AEW541 effected a reduction in IGF-stimulated IGF-IR phosphorylation, promoted apoptosis, and inhibited the growth of tumor cells in vivo. Blockade of the IGF-IR also dose-dependently inhibited the growth of serum-starved BON cells stimulated with 100 ng/mL of IGF-I, and resulted in increased antiproliferative effect when done in combination with administration of doxorubicin or fluvastatin.
These data suggest that targeting the IGF-IR using IMC-A12 may effectively inhibit tumor growth in the clinical setting. Furthermore, it is possible that the patients most likely to benefit from IGF-IR inhibition are those patients most likely to become refractory to available therapies and suffer from poor prognosis. In 2005, Furukawa, et al reported that high levels of IGF-IR expression were associated with faster tumor growth, increased aggressiveness, and lower likelihood of cure in one NET subtype (gastrinoma). Collectively, these findings provide a rationale for the proposed clinical evaluation of IMC-A12 in the treatment of neuroendocrine tumors.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michelle Coon, RN | 908-243-9983 | michelle.coon@Imclone.com |
United States, Indiana | |
lndiana University Melvin and Bren Simon Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Principal Investigator: Patrick Loehrer, Sr, MD |
Study Director: | Hagop Youssoufian, MD | ImClone Systems |
Responsible Party: | ImClone Systems Incorporated ( Eric Rowinsky/ Chief Medical Officer ) |
Study ID Numbers: | CP13-0710 |
Study First Received: | October 27, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00781911 |
Health Authority: | United States: Food and Drug Administration |
Islet Cells CARCINOMA, ISLET CELL Octreotide |
depot octreotide acetate Insulin-Like Growth Factor 1 Metastatic, Carcinoid or Islet Cell |
Carcinoma, Islet Cell Octreotide Insulin Carcinoma Neuroendocrine Tumors Carcinoid tumor Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Carcinoid Tumor Adenocarcinoma Pancreatic islet cell tumors Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Antineoplastic Agents |
Therapeutic Uses Neoplasms, Nerve Tissue Gastrointestinal Agents Pharmacologic Actions |