Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Contact information



Primary contact

Mr Lee Webber


Contact details

Cancer Research UK & UCL Cancer Trials Centre
90 Tottenham Court Road
United Kingdom

Additional identifiers

EudraCT number

2009-017171-13 number


Protocol/serial number


Study information

Scientific title

A randomised placebo-controlled trial of saracatinib (AZD0530) plus weekly paclitaxel in platinum-resistant ovarian, fallopian tube or primary peritoneal cancer



Study hypothesis

This is a randomised, placebo-controlled double-blind trial. The overall aim is to investigate whether the addition of the Src inhibitor saracatinib (AZD0530) to weekly paclitaxel improves efficacy, compared with paclitaxel plus placebo, in patients with relapsed platinum-resistant ovarian cancer. The trial will also determine toxicity and ascertain whether the combination of paclitaxel plus saracatinib should proceed to a phase III trial.

Ethics approval

Coventry & Warwickshire Research Ethics Committee, 04/08/2010, ref: 10/H1211/26

Study design

Multicentre randomised interventional treatment trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Ovary


Paclitaxel 80 mg/m2 (IV) to be given in 'cycles'. Each cycle will be 8 weeks of treatment, consisting of six weekly administrations of paclitaxel 80 mg/m2 followed by 2 weeks rest. Patients will receive four cycles to begin with. If there is evidence of ongoing response after four cycles, three 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 four cycles, treatment should be discontinued but may continue at the discretion of the Investigator. The maximum chemotherapy treatment period will be 56 weeks.

Saracatinib (AZD0530). Patients will receive 175 mg/matched placebo daily. Administration will begin 1 week prior to commencement of paclitaxel chemotherapy, and will continue until the patient's disease progresses/relapses. Combined with chemotherapy, the maximum treatment period of saracatinib/placebo will be 57 weeks.

Patients who progress/relapse during trial treatment will be taken off study and not followed up. Patients who do not relapse/progress during trial treatment will be followed up and offered saracatinib/placebo monotherapy. These patients will be followed up 6 weekly for 2 years or until progression, whichever is the sooner.

Intervention type



Phase II/III

Drug names

Saracatinib (AZD0530), paclitaxel

Primary outcome measure

Six-month progression-free survival (PFS), based on combined RECIST v1.1/GCIG CA125 criteria

Secondary outcome measures

1. Duration of response
2. Health Economics and Quality of Life outcomes based on FACT-O and EQ5D
3. Investigator Assessed PFS based on RECIST v1.1
4. Investigator Assessed Time to Progression
5. Objective Response Rate based on Investigator assessment using GCIG CA125 criteria and RECIST v1.1
6. Overall survival rate at 2 years
7. Safety and tolerability (toxicity)
8. Time to Progression based on RECIST v1.1

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Confirmed relapsed ovarian, fallopian tube or primary peritoneal cancer AND patients who have relapsed in the platinum-resistant (progression must not be based on CA125 alone) time-frame, i.e. have progressed within 6 months of platinum therapy
2. All patients must have formalin-fixed paraffin-embedded (FFPE) tissue available for translational research: this tissue may be tissue taken at original diagnosis
3. Patients need not have received prior taxane; if patients have received prior taxane, the interval since treatment must be known. Patients will be stratified as less than 6 months OR at least 6 months taxane interval/no prior taxane.
4. Patients will generally have received at least two lines of prior chemotherapy, but may enter if they have relapsed within 6 months of first-line therapy. Patients may have received prior liposomal doxorubicin, although this is NOT a requirement. The treatment immediately prior to study entry need not be platinum-based.
5. Measurable or evaluable disease (if not measurable by Response Evaluation Criteria in Solid Tumours version 1.1 [RECIST v1.1] criteria, must be evaluable by CA125 [GCIG criteria])
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2
7. Adequate haematological and biochemical function as follows:
7.1. Granulocyte count greater than 1.5 x 10^9/l
7.2. Platelet count greater than 100 x 10^9/l
7.3. Haemoglobin (Hb) greater than 9.0 g/dl
7.4. Serum creatinine less than 1.5 x upper limit of normal (ULN)
7.5. Bilirubin less than 1.5 x ULN. In cases of known Gilbert's syndrome, bilirubin less than 2 x ULN is allowed
7.6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than 2.5 x ULN
7.7. Alkaline phosphatase (ALP) less than 5 x ULN
7.8. Prothrombin and activated partial thromboplastin times less than 1.5 x ULN
8. Willingness to consent to take part in Level 1 of the translational sub-study, as per section 19.0 of the protocol (this is NOT optional)

Participant type


Age group




Target number of participants

Planned sample size: 102; UK sample size: 102

Participant exclusion criteria

1. Prior administration of weekly paclitaxel
2. Tumours of malignant mixed mesodermal (MMMT) or mucinous types
3. Unresolved bowel obstruction
4. Chemotherapy within the preceding 3 weeks
5. Radiotherapy within the preceding 3 weeks
6. Treatment with any investigational agent within the preceding 4 weeks or within 5 half-lives of the investigational agent, whichever is longer
7. Known leptomeningeal involvement or intracranial disease
8. Evidence of interstitial lung disease (bilateral, diffuse, parenchymal lung disease)
9. Resting electrocardiogram (ECG) with measurable QTc interval of greater than 480 msec at two or more time points within a 24-hour period
10. Pregnant or lactating females
11. Fertile women of childbearing potential not willing to use adequate contraception for the duration of trial treatment and for at least 30 days after the last administration of saracatinib +/- paclitaxel
12. Inability or unwillingness to give informed consent
13. Ongoing active infection or a documented history of human immunodeficiency virus (HIV) infection, hepatitis B or C
14. Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease
15. Concurrent autoimmune disorder, e.g. systemic lupus or any demyelinating disease
16. Use of immunosuppressive therapy or corticosteroids taken within the 4 weeks prior to study entry and during the treatment period

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Cancer Research UK & UCL Cancer Trials Centre
United Kingdom

Sponsor information


University College London (UCL) (UK)

Sponsor details

Gower Street
United Kingdom

Sponsor type




Funder type


Funder name


Alternative name(s)

AstraZeneca PLC

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)


United Kingdom

Funder name

Cancer Research UK- Clinical Trials Advisory and Awards Committee (CTAAC) grant (ref: C9423/A11569)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)


Publication list

2014 results in:

Publication citations

  1. Results

    McNeish IA, Ledermann JA, Webber L, James L, Kaye SB, Hall M, Hall G, Clamp A, Earl H, Banerjee S, Kristeleit R, Raja F, Feeney A, Lawrence C, Dawson-Athey L, Persic M, Khan I, A randomised placebo-controlled trial of weekly paclitaxel and saracatinib (AZD0530) in platinum-resistant ovarian, fallopian tube or primary peritoneal cancer., Ann. Oncol., 2014, doi: 10.1093/annonc/mdu363.

Additional files

Editorial Notes

24/03/2016: added link to results - basic reporting.