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B-GT/13: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised:
February 28, 2006
)
Title |
A phase III, multi-center, open-label, randomized study to compare the overall survival and safety of bi-weekly intratumoral administration of INGN 201 versus weekly methotrewate in 240 patients with refractory squamous cell carcinoma of the head and neck (SCCHN) |
|
Company or sponsor |
Introgen Therapeutics, Inc. |
|
Pharmaceutical study code |
INGN 201 (Ad5CMV-p53) - T301 |
|
Phase |
III |
|
Unicenter/multicenter study |
multicenter |
|
| Clinical data | see table 2 | |
Installation |
Cliniques Universitaires Saint-Luc, Brussels |
Akademisch Ziekenhuis, Vrije Universiteit Brussel |
Authorisation procedure |
contained use, modification of operation (see relevant regulation) |
contained use, renewal and modification of operation (see relevant regulation) |
Application number |
SBB 219 2001/1106 |
SBB 219 2002/0443 |
User(s) |
Dr V. D'Hondt and Dr J.-P. Machiels |
Prof. J. De Grève |
Receipt date |
09/11/2001 |
17/05/2002 |
Biosafety Council meeting date |
04/02/2002 |
- |
Authorisation date |
17/06/2002 |
1/08/2002 |
Status |
sponsor decided to cancel the trial in Belgium |
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