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B-GT/3: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised:
February 28, 2006
)
Title |
A phase I study in patients with recurrent or metastatic squamous cell carcinoma of the head and neck using SCH 58500 (rAd/p53) administered by single intratumoral injection |
Company or sponsor |
Schering Plough NV/SA |
Pharmaceutical study code |
I95-177-03 |
Phase |
I |
Unicenter/multicenter study |
multicenter |
| Clinical data | see table 2 |
Installation |
Universitair Ziekenhuis Gasthuisberg, Leuven |
Authorisation procedure |
contained use, first use (see relevant regulation) |
Application number |
SBB 219 96/0548 |
User(s) |
Prof. Dr W. Van den Bogaert, Prof. Dr P. Delaere, Dr K. Haustermans and Prof. Dr A.T. Van Oosterom |
Receipt date |
21/10/1996 |
Biosafety Council meeting date |
16/12/1996 |
Authorisation date |
05/03/1997 |
Status |
trial completed |
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