SarCaBon: a randomised phase II trial of saracatinib versus placebo for cancer-induced bone pain
ISRCTN | ISRCTN60942134 |
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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
Contact information
Dr Janet Horsman
Scientific
Scientific
Department of Clinical Oncology
Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
United Kingdom
J.M.Horsman@sheffield.ac.uk |
Study information
Study design | Randomised; Interventional; Design type: Treatment |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient 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 |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | Saracatinib |
Primary outcome measure | Pain score: Whether patientsÂ’ 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 |
Completion date | 31/07/2017 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | Planned Sample Size: 62; UK Sample Size: 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
- England
- United Kingdom
Study participating centre
Weston Park Hospital
Sheffield
S10 2SJ
United Kingdom
S10 2SJ
United Kingdom
Sponsor information
Sheffield Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research Department
11 Broomfield Road
Sheffield
S10 2SE
England
United Kingdom
https://ror.org/018hjpz25 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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 |
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.