Study of Everolimus as Maintenance Therapy for Metastatic NEC With Pulmonary or Gastroenteropancreatic Origin
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|ClinicalTrials.gov Identifier: NCT02687958|
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : February 8, 2017
Cisplatin and Etoposide is the standard of care in NEC originating from the gastro-intestinal tract and lung, based on retrospective studies.
Nevertheless the prognosis of this group of patients is still poor with median survival of less than 20 months.
Everolimus is an mammilian target of rapamycin (mTOR) inhibitor that has been demonstrated to be active in patients with well and moderately differentiated primitive neuroectodermal tumor (pNET).
Recently, the Investigators demonstrated that the mammilian target of rapamycin (mTOR) pathway is overexpressed in NEC.
Based on the activity of Everolimus in the treatment of patients with well and moderately differentiated p-NET and on the evidence that even poorly differentiated forms express the pathway of m-TOR is conceivable that Everolimus could be active even in NEC.
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Carcinoma||Drug: Everolimus||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Randomized Multicenter Study of Everolimus as Maintenance Therapy for Metastatic Neuroendocrine Carcinoma With Pulmonary or Gastroenteropancreatic Origin|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||May 2017|
Experimental: A Everolimus 10mg (every cycle) until PD
Patients with stable disease, partial response or complete response after 4- 6 cycles of induction chemotherapy with Cisplatin or Carboplatin plus Etoposide or alternative first line chemotherapy according with local practice will receive maintenance therapy with Everolimus 10mg every cycle (28days) until PD or unacceptable toxicity.
Other Name: Afinitor
No Intervention: B Observational
Patients in this arm will meet observation criteria
- PFS [ Time Frame: 24 months ]progression free survival (PFS)
- OS [ Time Frame: 24 months ]Overall survival (OS)
- ctDNA [ Time Frame: 24 months ]circulating DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687958
|Contact: Luisa Di Cerbo, SCfirstname.lastname@example.org|
|Contact: Alessandro Di Costanzo, SCemail@example.com|
|S.C. Oncologia - Policlinico||Active, not recruiting|
|Modena, Emilia - Romagna, Italy, 41124|
|U.O. Oncologia Medica 1 - AOU Pisana||Recruiting|
|Pisa, Tuscany, Italy, 56126|
|Contact: Cinzia Orlandini, SC|
|Principal Investigator: Sergio Ricci, MD|
|Azienda Ospedaliera "Spedali Civili di Brescia"||Active, not recruiting|
|Brescia, Italy, 25123|
|Azienda Ospedaliera Universitaria Careggi||Recruiting|
|Florence, Italy, 50134|
|Contact: Luisa Di Cerbo, SC +390557947298 firstname.lastname@example.org|
|Contact: Alessandro Di Costanzo, SC +390557947298 email@example.com|
|Principal Investigator: Francesco Di Costanzo, MD|
|Principal Investigator: Lorenzo Antonuzzo, MD|
|Istituto Europeo di Oncologia||Active, not recruiting|
|Milano, Italy, 20141|
|Principal Investigator:||Francesco Di Costanzo, MD||AOU Careggi|
|Principal Investigator:||Lorenzo Antonuzzo, MD||AOU Careggi|