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

ISRCTN ISRCTN60942134
DOI https://doi.org/10.1186/ISRCTN60942134
EudraCT/CTIS number 2013-002505-62
ClinicalTrials.gov number NCT02085603
Secondary identifying numbers 15852
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

Study designRandomised; Interventional; Design type: Treatment
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleSarCaBon: a randomised phase II trial of saracatinib versus placebo for cancer-induced bone pain
Study acronymSarCaBon
Study objectivesThe 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) studiedTopic: National Cancer Research Network; Subtopic: All Cancers/Misc Sites; Disease: All
InterventionSaracatinib 125mg per day or placebo for 28 days
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Saracatinib
Primary outcome measurePain score: Whether patientsÂ’ self-reported pain scores are significantly lower after 4 weeks on treatment with
Secondary outcome measuresNot provided at time of registration
Overall study start date01/02/2014
Completion date31/07/2017

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 62; UK Sample Size: 62
Total final enrolment13
Key inclusion criteria1. 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 criteria1. 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 enrolment01/02/2014
Date of final enrolment01/02/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Weston Park Hospital
Sheffield
S10 2SJ
United Kingdom

Sponsor information

Sheffield Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre

Research Department
11 Broomfield Road
Sheffield
S10 2SE
England
United Kingdom

ROR logo "ROR" https://ror.org/018hjpz25

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

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.