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Spots Global Cancer Trial Database for A Study of Sunitinib Versus Placebo in Combination With Lanreotide in Patients With Progressive Advanced/Metastatic Midgut Carcinoid Tumors

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Trial Identification

Brief Title: A Study of Sunitinib Versus Placebo in Combination With Lanreotide in Patients With Progressive Advanced/Metastatic Midgut Carcinoid Tumors

Official Title: A RANDOMIZED PHASE II DOUBLE-BLIND TRIAL OF SUNITINIB VERSUS PLACEBO IN COMBINATION WITH LANREOTIDE IN PATIENTS WITH PROGRESSIVE ADVANCED/METASTATIC MIDGUT CARCINOID TUMORS

Study ID: NCT01731925

Study Description

Brief Summary: Sunitinib may provide an opportunity for a novel therapeutic strategy for the treatment of subjects with neuroendocrine tumors.

Detailed Description: With the exception of surgery for localized disease, there is presently a lack of available therapies with proven survival benefit for patients with neuroendocrine tumors (NET). Available treatment options for unresectable disease include the use of somatostatin analogs, which may relieve symptoms related to hormonal hypersecretion. The efficacy of cytotoxic chemotherapy in patients with metastatic carcinoid tumors is also limited. Combinations of either streptozocin and cyclophosphamide, or streptozocin and 5-fluorouracil, appear to be inactive, and both regimens are associated with substantial toxicity. Receptor tyrosine kinases (RTKs) are implicated in deregulated/ autocrine proliferation and survival of solid and hematologic cancer cells. Sunitinib malate is an orally administered small molecule that inhibits the tyrosine kinase enzymatic activities of the receptors for VEGF and PDGF, and also blocks signalling through the KIT, FLT3 and RET pathways. Therefore, sunitinib malate may provide an opportunity for a novel therapeutic strategy for the treatment of subjects with NET.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Cliniques Universitaires Saint Luc, Brussels, , Belgium

Institut Jules Bordet, Brussels, , Belgium

ULB Erasme, Brussels, , Belgium

UZ Antwerpen, Edegem, , Belgium

UZ Gent, Gent, , Belgium

UZ Leuven, Leuven, , Belgium

H么pital Saint Andr茅, Bordeaux, , France

H么pital Beaujon, Clichy, , France

H么pital Henri Mondor, Cr茅teil, , France

Hopital Saint Vincent de Paul, Lille, , France

H么pital Edouard Herriot, Lyon, , France

CHU La Timone, Marseille, , France

H么pital St Antoine, Paris, , France

CHU Cochin, Paris, , France

H么pital Piti茅 Salp锚tri猫re, Paris, , France

Institut Mutualiste Montsouris, Paris, , France

CHU Robert Debr茅, Reims, , France

CHU Pontchaillou, Rennes, , France

CHU Rouen, Rouen, , France

CHRU Trousseau, Tours, , France

Contact Details

Name: Pascal HAMMEL, MD

Affiliation: H么pital Beaujon

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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