Ignite Creation Date:
2024-05-06 @ 12:24 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01567488
Status:
COMPLETED
Last Update Posted:
2018-01-03
First Post:
2012-03-26
Brief Title:
Phase II Study of Everolimus Combined With Octreotide LAR to Treat Advanced GI NET
Sponsor:
Grupo Espanol de Tumores Neuroendocrinos
Organization:
Grupo Espanol de Tumores Neuroendocrinos
Study Overview
Official Title:
A Phase II Study on Everolimus an mTOR Inhibitor Oral Formulation With Octreotide LAR in Adult Patients With Advanced Non-functioning Well-differentiated Gastrointestinal Neuroendocrine Tumours GI NET
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVERLAR
Brief Summary:
The underlying hypothesis of the synergistic activity of octreotide and everolimus is based on the combination of a a direct action of everolimus over mTOR mammalian target of rapamycin and b the inhibitory effect of octreotide on the IGF-I insulin like growth factor 1 system preventing the activation of the mTOR system by this factor Both types of inhibition would completely cancel this signal transduction pathway which is so important in neuroendocrine tumours
Furthermore the biological study proposed in this protocol will allow for better establishing the relationship between the activation of the IGFR-PI3K-mTOR signal transduction pathway ie the mTOR pathway stimulated by IGFR and treatment response this information is relevant since the IGFR-PI3K-mTOR activation status could be a response prediction factor
This study will provide significant additional information about the efficacy of the combination treatment of everolimus with octreotide LAR in non-functioning GI NET
Furthermore the biological study proposed in this protocol will allow for better establishing the relationship between the activation of the IGFR-PI3K-mTOR signal transduction pathway ie the mTOR pathway stimulated by IGFR and treatment response this information is relevant since the IGFR-PI3K-mTOR activation status could be a response prediction factor
This study will provide significant additional information about the efficacy of the combination treatment of everolimus with octreotide LAR in non-functioning GI NET
Detailed Description:
Everolimus has been developed following two administration regimens weekly and daily Phase I pharmacodynamic studies recommend doses of 50 mg weekly and 10 mgdaily based on its toxicity and inhibitory effect of the mTOR pathway in tumours although the inhibition of this pathway has been demonstrated the knowledge of response prediction factors has not been developed in part due to the very low responses found in the population in phase I studies These factors can be better outlined in a phase II study where patients who have received fewer previous treatments can respond better and where the profile of responders and non-responders can be identified more easily
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CRAD001KES08T | OTHER_GRANT | Novartis Farmacéutica SA | None |