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Brief Title: Sandostatin LAR and Axitinib vs Pbo in Pnts With Advanced Well-differentiated Non-pancreatic Neuroendocrine Carcinomas
Official Title: A Phase II/III Randomized Double-blind Study of Sandostatin LAR in Combination With Axitinib Versus Sandostatin LAR With Placebo in Patients With Advanced G1-G2 Neuroendocrine Tumours (WHO 2010) of Non-pancreatic Origin
Study ID: NCT01744249
Brief Summary: Assess whether therapy with axitinib, a potent angiogenic inhibitor of the tyrosine kinase receptors of VEGF bioavailable by oral administration, is capable of improving PFS in patients with advanced G1-G2 NETs of nonpancreatic origin with progressive disease documented in the 12 months prior to entering the study.
Detailed Description: Phase II/III, prospective, multicenter, randomized (1:1), double-blind study to evaluate the efficacy and tolerability of axitinib in patients diagnosed with advanced G1-G2 neuroendocrine tumors (WHO 2010) of nonpancreatic origin that have presented documented disease progression in the 12 months prior to entering the study. In the first part of the study (Phase II), 105 patients were enrolled. The second part of the study is the expansion to Phase III, which is expected to include 148 additional patients. Patients will be randomized to receive Sandostatin LAR with axitinib or Sandostatin LAR with placebo until disease progression or unacceptable toxicity occurs. Randomization will be stratified by the time from diagnosis to enrollment in the study (more vs less than or equal to 12 months), the origin of the primary tumor (gastrointestinal tract vs non-gastrointestinal tract \[lung or other sites\]) and ki-67 (\< 5% vs \> 5%).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Marburg Universitätsklinikum Giessen und Marburg GmbH, Marburg, , Germany
Azienda Ospedaliera Universitaria di Perugia, Perugia, , Italy
Sapienza, Universitá di Roma, Ospedale sant'Andrea, Rome, , Italy
Hospital Central de Asturias, Oviedo, Asturias, Spain
Institut Català d'Oncologia L'Hospitalet, L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Virgen de la Victoria, Málaga, Malaga, Spain
Hospital Alvaro Cunqueiro, Vigo, Pontevedra, Spain
Complejo Hospitalario Univ A Coruña, A Coruña, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario de Burgos, Burgos, , Spain
Hospital Virgen de las Nieves, Granada, , Spain
Hospital universitario de Leon, Leon, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Clara Campal, Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Gregorio Marañón, Madrid, , Spain
Hospital Univ La Paz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Univ de Salamanca, Salamanca, , Spain
Hospital de Donostia, San Sebastian, , Spain
Hospital Marqués de Valdecilla, Santander, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Clatterbridge Cancer Centre, Bebington, Wirral, United Kingdom
Name: Rocio Garcia Carbonero, MD
Affiliation: Hospital 12 de Octubre
Role: STUDY_CHAIR