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B-GT/14: 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 effectiveness and safety of intratumoral administration of INGN 201 in combination with chemotherapy versus chemotherapy alone in 288 patients with recurrent squamous cell carcinoma of the head and neck (SCCHN) |
|
Company or sponsor |
Introgen Therapeutics, Inc. |
|
Pharmaceutical study code |
INGN 201 (Ad5CMV-p53) - T302 |
|
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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