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Spots Global Cancer Trial Database for Sandostatin LAR and Axitinib vs Pbo in Pnts With Advanced Well-differentiated Non-pancreatic Neuroendocrine Carcinomas

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Trial Identification

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

Study Description

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%).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Rocio Garcia Carbonero, MD

Affiliation: Hospital 12 de Octubre

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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