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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Pascal HAMMEL, MD
Affiliation: H么pital Beaujon
Role: PRINCIPAL_INVESTIGATOR