Avalte - A single arm, open label, multicenter, extension study of bevacizumab in patients with solid tumors on study treatment with bevacizumab, at the end of A F. HOFFMAN-LA ROCHE and/or GENENTECH sponsored study (MO25757)
Project number : 245661
Created by: Ylva Storck, 2018-03-20
Last revised by: Ylva Storck, 2019-01-18
Project created in: FoU Region Örebro län

Completed

2015-02-03: Rekrytering/datainsamling pågår

2015-05-31: Projektet avslutat

Registeranmälan

Avalte - A single arm, open label, multicenter, extension study of bevacizumab in patients with solid tumors on study treatment with bevacizumab, at the end of A F. HOFFMAN-LA ROCHE and/or GENENTECH sponsored study (MO25757), PUL-anmälan
Avalte - A single arm, open label, multicenter, extension study of bevacizumab in patients with solid tumors on study treatment with bevacizumab, at the end of A F. HOFFMAN-LA ROCHE and/or GENENTECH sponsored study (MO25757), Projektbeskrivning

Titel och sammanfattning

Populärvetenskaplig sammanfattning

Multicenter, open-label, single-arm phase IIIb/IV trial. Patients on bevacizumab at P-trial end should be enrolled immediately thereafter. Patients will receive treatment with bevacizumab as during their P-trial until progression of disease, unacceptable toxicity, withdrawal of consent or death (whichever occurs first).

Projektspecifik information

Ämnesord

Cancer och onkologi

(Only selected options are displayed. Click here to display all options)

Studietyp

Prövning av läkemedel

Fas

III

Randomiserad studie

Nej

Diagnoskod för huvuddiagnos

C51-C58 Maligna tumörer i de kvinnliga könsorganen

Multicenterstudie

EudraCTnr

2011-002009-31

Protokollnummer på prövningen

MO25757

Etikprövningsmyndighetens diarienummer

2014/358

Biobanksavtal

Ej aktuellt

Inklusionsstatus

	Planerat antal	Antal tillfrågade	Screen-failure	Antal randominserade
n=	1	1		1 inkluderad

Vetenskaplig sammanfattning

Primary objectives:

to provide continued bevacizumab therapy as single agent or in combination with an anti-cancer drug topatients with cancer, who were previously enrolled in a F. Hoffman-La Roche / Genentech sponsored bevacizumab trial and who derived benefit from the therapy.

to collect safety data with regard to long-term administration of bevacizumab.

Involverade parter

Arbetsplats

Added workplaces

Regioner - Region Örebro Län - Hälso- och sjukvård - Område opererande och onkologi - Onkologiska kliniken

Sponsor

Added workplaces

Företag - Läkemedel etc - Roche

Nationell koordinator

Added workplaces

Regioner - Region Örebro Län - Hälso- och sjukvård - Område opererande och onkologi - Onkologiska kliniken