Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180921
Status:
UNKNOWN
Last Update Posted:
2007-09-26
First Post:
2005-09-13
Brief Title:
Study of Imatinib Glivec in Patients With Adenoid Cystic Carcinoma of the Head and Neck
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
Phase II Study of Imatinib Glivec Administered as a Daily Oral Treatment in Patients With RecurrentMetastatic Adenoid Cystic Carcinoma of the Head and Neck Overexpressing KIT
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
RECRUITING
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:
None
Brief Summary:
This is a Phase II study of imatinib Glivec administered as a daily oral treatment in patients with recurrentmetastatic adenoid cystic carcinoma of the head and neck overexpressing KIT
Detailed Description:
Patients with relapsing andor metastatic adenoid cystic carcinoma of the salivary gland of the head and neck are usually poor responders to conventional cytotoxic chemotherapy
The investigation of proliferation pathways involving tyrosine kinase receptors such as c-kit receptor KIT and PDGF receptor may allow to identify a molecular target for novel therapeutic approaches in patients with adenoid cystic carcinoma who failed locoregional treatment
Several publications in the literature and the pathological study we conducted in Institut Gustave Roussy show that KIT overexpression is observed in at least 80-90 of the cases of adenoid cystic carcinoma supporting the investigation of imatinib in patients with adenoid cystic carcinoma overexpressing KIT
Imatinib is an orally administrated well tolerated compound that could be given on an outpatient schedule to patients with relapsingmetastatic adenoid cystic carcinoma of the head and neck
Because of the infrequent occurrence of salivary gland malignancies a multicenter trial will be mandatory and the study will include at least 2 centers represented by Institut Gustave Roussy Villejuif and Hôpital Georges-Pompidou Paris
The investigation of proliferation pathways involving tyrosine kinase receptors such as c-kit receptor KIT and PDGF receptor may allow to identify a molecular target for novel therapeutic approaches in patients with adenoid cystic carcinoma who failed locoregional treatment
Several publications in the literature and the pathological study we conducted in Institut Gustave Roussy show that KIT overexpression is observed in at least 80-90 of the cases of adenoid cystic carcinoma supporting the investigation of imatinib in patients with adenoid cystic carcinoma overexpressing KIT
Imatinib is an orally administrated well tolerated compound that could be given on an outpatient schedule to patients with relapsingmetastatic adenoid cystic carcinoma of the head and neck
Because of the infrequent occurrence of salivary gland malignancies a multicenter trial will be mandatory and the study will include at least 2 centers represented by Institut Gustave Roussy Villejuif and Hôpital Georges-Pompidou Paris
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