Title

A phase II/III trial of chemotherapy alone versus chemotherapy plus SCH 58500 in newly diagnosed stage III ovarian and primary peritoneal cancer patients with superior or equal 0.5 cm and inferior or equal 2 cm residual disease following surgery

Company or sponsor

Schering Plough NV/SA

Pharmaceutical study code

I98-102

Phase

II/III

Unicenter/multicenter study

multicenter

Installation

Cliniques Universitaires Saint-Luc, Brussels

Akademisch Ziekenhuis, Vrije Universiteit Brussel

Hôpital Erasme, Brussels

Akademisch Ziekenhuis St Augustinus, Wilrijk

Authorisation procedure 1

contained use, modification of operation (see relevant regulation)

contained use, modification of operation (see relevant regulation)

contained use, modification of operation (see relevant regulation)

contained use, first use (see relevant regulation)

Application number

SBB 219 99/0074

SBB 219 99/0067

SBB 219 99/0321

SBB 219 2000/0192

User(s)

Dr V. D'Hondt

Prof. Dr J. De Grève

Prof. Dr T. Velu

Dr L. Dirix

Receipt date

10/02/1999

10/02/1999

19/05/1999

01/03/2000

Biosafety Council meeting date

-

-

-

-

Authorisation date

09/04/1999*

09/04/1999*

18/07/1999*

02/06/2000

Authorisation procedure 2

deliberate release for research and development purposes (see regulation in french - in dutch)

Application number

B/BE/98/B6

Status

trial completed