Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT03578432
Status:
TERMINATED
Last Update Posted:
2019-12-02
First Post:
2018-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Everolimus in Restoring Salivary Gland Function in Participants With Locally Advanced Head and Neck Cancer Treated With Radiation Therapy
Sponsor:
University of Arizona
Organization:
Study Overview
Official Title:
Clinical Evaluation of Everolimus (a Rapamycin Analog) in Restoring Salivary Gland Function to Patients Treated With Radiotherapy for Head and Neck Cancer
Status:
TERMINATED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
UACC-PHX is no longer able to support the study and Novartis is unable to provide drug beyond December 2019.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This early phase 1 trial studies the use of everolimus in restoring salivary gland function in participants with locally advanced head and neck cancer after concurrent chemoradiation or radiation therapy alone.
Detailed Description:
PRIMARY OBJECTIVES:
I. To describe the recovery of salivary gland function after administration of a 5-day course of everolimus, administered two weeks after completion of radiation or chemoradiation therapy.
SECONDARY OBJECTIVES:
I. To describe the decrease of saliva flow rates during radiation or chemoradiation therapy.
II. To describe the changes in saliva protein composition during radiation or chemoradiation therapy and following administration of a 5-day course of everolimus.
OUTLINE: This is an early phase 1 proof of principal study.
Participants receive everolimus orally (PO) once daily (QD) for 5 days beginning 2 weeks after completion of radiation or chemoradiation treatment. Participants also undergo saliva output testing at baseline prior to radiation or chemoradiation treatment, after 3 weeks of RT/chemoRT, after 6 weeks of RT/chemoRT, prior to everolimus administration, at completion of the 5 day everolimus course, and at 1, 3, and 6 months after the completion of radiation or chemoradiation therapy.
I. To describe the recovery of salivary gland function after administration of a 5-day course of everolimus, administered two weeks after completion of radiation or chemoradiation therapy.
SECONDARY OBJECTIVES:
I. To describe the decrease of saliva flow rates during radiation or chemoradiation therapy.
II. To describe the changes in saliva protein composition during radiation or chemoradiation therapy and following administration of a 5-day course of everolimus.
OUTLINE: This is an early phase 1 proof of principal study.
Participants receive everolimus orally (PO) once daily (QD) for 5 days beginning 2 weeks after completion of radiation or chemoradiation treatment. Participants also undergo saliva output testing at baseline prior to radiation or chemoradiation treatment, after 3 weeks of RT/chemoRT, after 6 weeks of RT/chemoRT, prior to everolimus administration, at completion of the 5 day everolimus course, and at 1, 3, and 6 months after the completion of radiation or chemoradiation therapy.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-00492 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CRAD001XUA274T | None | None | View | |
| PHXB-17-0072-70-15 | OTHER | The University of Arizona Cancer Center | View | |
| P30CA023074 | NIH | None | https://reporter.nih.gov/quic… | View |