Plain English Summary
Study website
Contact information
Type
Scientific
Contact name
Dr Janet Horsman
ORCID ID
Contact details
Department of Clinical Oncology
Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
United Kingdom
-
J.M.Horsman@sheffield.ac.uk
Additional identifiers
EudraCT/CTIS number
2013-002505-62
IRAS number
ClinicalTrials.gov number
NCT02085603
Protocol/serial number
15852
Study information
Scientific title
SarCaBon: a randomised phase II trial of saracatinib versus placebo for cancer-induced bone pain
Acronym
SarCaBon
Study hypothesis
The aim of this randomised double-blind phase II trial is to determine whether Saracatinib has clinical efficacy as an analgesic for bone pain that is due to bone metastases in cancer patients by comparing patients' self-reported pain ratings after 4 weeks on treatment, with pain scores from patients who receive placebo
Ethics approval(s)
First MREC approval date 24/10/2013, ref: 13/YH/0263
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: All Cancers/Misc Sites; Disease: All
Intervention
Saracatinib 125mg per day or placebo for 28 days
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase II
Drug/device/biological/vaccine name(s)
Saracatinib
Primary outcome measure
Pain score: Whether patients self-reported pain scores are significantly lower after 4 weeks on treatment with
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/02/2014
Overall study end date
31/07/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Able to give written informed consent and willing to follow the study protocol
2. Age = 16 years
3. Cytologically or histologically confirmed solid tumours of known primary site with painful bone metastases and poor control of bone pain
4. WHO performance status = 2
5. Average baseline pain score = 4 and = 9 on 10 numerical scale recorded over at least two separate days
6. Adequate baseline haematological, hepatic and renal function, defined as follows:
Absolute neutrophil count = 1.5 x 109/L, Haemoglobin >9.0 g/dL (can be after transfusion), Platelet count = 100 x 109/L, Bilirubin = 1.5 x ULN, ALT or AST = 2.5 x ULN (= 5 x ULN if liver metastases), Creatinine = 1.5 x ULN
7. Ability to take and absorb oral medications
8. Female patients of childbearing potential (i.e. premenopausal females, females who have been menopausal for < 1 year and not surgically sterilized) must provide a negative pregnancy test (serum) = 7 days before study treatment begins and must agree to practice effective contraceptive measures (oral contraceptive pill, intrauterine device or diaphragm with spemicide) plus condoms during the study and for 30 days after last dose of saracatinib
9. Male patients with a partner of childbearing potential (who is not using an acceptable highly effective method of contraception) or a pregnant partner must use effective contraceptive measures (see 8) plus condoms during the study and for 3 months after the last dose of saracatinib. Patients should abstain from sperm donation during the study and for 3 months after the last dose of saracatinib
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
Planned Sample Size: 62; UK Sample Size: 62
Total final enrolment
13
Participant exclusion criteria
1. Life expectancy less than 3 months
2. Previous or planned radiotherapy at site of pain
3. Unstable cardiac disease in last 3 months
4. History of interstitial lung disease (bilateral, diffuse parenchymal lung disease) in view of known saracatinib-related pneumonitis
5. Unable to discontinue any medication with known moderate or potent inhibitory effect on CYP3A4, or is a substrate of CYP3A4
6. Concomitant cytotoxic chemotherapy unless established on maintenance treatment for > 6 weeks (not in a clinical trial)
7. Unable to understand written or spoken English as the primary outcome is dependent on completion of the BPISF questionnaire
Recruitment start date
01/02/2014
Recruitment end date
01/02/2016
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Weston Park Hospital
Sheffield
S10 2SJ
United Kingdom
Sponsor information
Organisation
Sheffield Teaching Hospitals NHS Trust (UK)
Sponsor details
Research Department
11 Broomfield Road
Sheffield
S10 2SE
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 28/05/2020 | No | No | ||
| HRA research summary | 28/06/2023 | No | No |