Double blind study of Axitinib in progressive advanced G1-G2 NETs
Research type
Research Study
Full 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
IRAS ID
211287
Contact name
Christina Thirlwell
Contact email
Sponsor organisation
Grupo Español de Tumores Neuroendocrinos
Eudract number
2011-001550-29
Duration of Study in the UK
3 years, 7 months, 2 days
Research summary
The incidence of Neuroendocrine tumor is 2.5 and 5 per 100,000 in the Caucasian population. In addition, the prevalence of these tumors is relatively high due to long survival, which can be 35% to 60% at 5 years for patients with advanced disease. Moreover, gastroenteropancreatic NETs are the second most prevalent tumors derived from the digestive tract, after colorectal carcinoma.
This is a Phase II/III, prospective, Multicenter, Randomized (1:1), Double-blind study. The Ultimate purpose of this trial is to assess whether therapy with Axitinib (anticancer drug) which is administered orally, can improve Progression Free Survival in patients with advanced G1-G2 NETs of non-pancreatic origin with progressive disease documented in the 12 months prior to entering the study. In the first part of the study (Phase II), 105 patients were enrolled in Spain. The second part of the study is the extension to Phase III, which is expected to include 148 additional patients.
In this clinical trial, patients will be randomized to receive:
A) Sandostatin LAR 30mg IM every 28 days with axitinib 5mg PO 2 times daily (BID)
Or
B) Sandostatin LAR 30mg IM every 28 days with Placebo PO 2 times daily (BID)
This designated treatment will continue until disease progression or occurrence of unacceptable toxicity. 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%).This clinical trial is sponsor by GETNE (Grupo Español de Tumores Neuroendocrinos [Spanish Group of Neuroendocrine Tumors]) and will take place at 3 sites in the UK.
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/0889
Date of REC Opinion
19 Jul 2017
REC opinion
Further Information Favourable Opinion