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B-GT/4: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised: February 28, 2006 )

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Title

A phase II gene therapy study in patients with non-small cell lung cancer using SCH58500 (rAd/p53) in combination with chemotherapy for multiple cycles

Company or sponsor

Schering Plough NV/SA

Pharmaceutical study code

I97-076-03

Phase

II

Unicenter/multicenter study

multicenter

Clinical data see table 2

Installation

Akademisch Ziekenhuis, Vrije Universiteit Brussel

Authorisation procedure

contained use, first use (see relevant regulation)

Application number

SBB 219 97/0919

User(s)

Prof. Dr J. De Grève

Receipt date

18/08/1997

Biosafety Council meeting date

-

Authorisation date

12/02/1998

Status

trial completed

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