Saracatinib and Paclitaxel in Platinum-resistant Ovarian Cancer

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

107

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

November 30, 2012

Study Completion Date

January 31, 2014

Conditions
Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer
Interventions
DRUG

Paclitaxel

Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

DRUG

Saracatinib

Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

DRUG

Matched placebo

Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Trial Locations (12)

BC2 0QQ

Addenbrooke's Hospital, Cambridge

EC1A 7BE

St Bartholomew's Hospital, London

NW1 2PG

University College London Hospital, London

SE1 9RT

Guy's Hospital, London

SW3 6JJ

The Royal Mardsen Hospital, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

HA6 2RN

Mount Vernon Hospital, Rickmansworth

OX3 7LJ

The Churchill Hospital, Oxford

DE13 0RB

Queen's Hospital, Burton-on-Trent

SM2 5PT

Royal Marsden Hospital, Sutton

LS9 7TF

St James's University Hospital, Leeds

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

Sponsors
All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Cancer Research UK

OTHER

lead

University College, London

OTHER