SarCaBon: a randomised phase II trial of saracatinib versus placebo for cancer-induced bone pain

ISRCTN	ISRCTN60942134
DOI	https://doi.org/10.1186/ISRCTN60942134
ClinicalTrials.gov (NCT)	NCT02085603
Clinical Trials Information System (CTIS)	2013-002505-62
Protocol serial number	15852
Sponsor	Sheffield Teaching Hospitals NHS Trust (UK)
Funder	Medical Research Council (MRC) (UK)

Submission date: 30/01/2014
Registration date: 30/01/2014
Last edited: 28/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-at-saracatinib-for-pain-caused-by-cancer-spread-to-the-bone-sarcabon

Contact information

Dr Janet Horsman
Scientific

Department of Clinical Oncology
Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
United Kingdom

Email	J.M.Horsman@sheffield.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	SarCaBon: a randomised phase II trial of saracatinib versus placebo for cancer-induced bone pain
Study acronym	SarCaBon
Study objectives	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
Health condition(s) or problem(s) studied	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
Phase	Phase II
Drug / device / biological / vaccine name(s)	Saracatinib
Primary outcome measure(s)	Pain score: Whether patients self-reported pain scores are significantly lower after 4 weeks on treatment with
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/07/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	62
Total final enrolment	13
Key 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
Key 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
Date of first enrolment	01/02/2014
Date of final enrolment	01/02/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Weston Park Hospital

Sheffield
S10 2SJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

28/05/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
09/08/2019: ClinicalTrials.gov number added.
06/03/2017: The overall trial end date was changed from 01/02/2016 to 31/07/2017.