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B-GT/7: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised:
February 28, 2006
)
Title |
A phase II, multi-center, open label, randomized study to evaluate biodistribution and transmission, effectiveness and safety of two treatment regimens of Ad5CMV-p53 administered by intra-tumoral injections in 40 evaluable patients with advanced squamous cell carcinoma of the head and neck (SCCHN) |
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Company or sponsor |
Rhone-Poulenc Rorer |
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Pharmaceutical study code |
Ad5CMV-p53T-207 |
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Phase |
II |
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Unicenter/multicenter study |
multicenter |
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| Clinical data | see table 2 | ||
Installation |
Hôpital Erasme, Bussels |
Cliniques Universitaires Saint-Luc, Brussels |
Universitair Ziekenhuis Antwerpen |
Authorisation procedure |
contained use, new operation (see relevant regulation) |
contained use, new operation (see relevant regulation) |
contained use, new operation (see relevant regulation) |
Application number |
SBB 219 98/0449 |
SBB 219 98/0458 |
SBB 219 99/0138 |
User(s) |
Prof. Dr T. Velu |
Dr V. D'Hondt |
Dr D. Schrijvers and Dr C.Van Laer |
Receipt date |
09/06/1998 |
10/06/1998 |
02/03/1999 |
Biosafety Council meeting date |
10/07/1998 |
- |
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Authorisation date |
24/07/1998 |
24/07/1998 |
23/07/1999 |
Status |
trial completed |
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