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

• Register: ISRCTN
• Last refreshed on: 8 June 2020
• Main ID: ISRCTN60942134
• Date of registration: 30/01/2014
• Prospective Registration: Yes
• Primary sponsor: Sheffield Teaching Hospitals NHS Trust (UK)
• Public title: SarCaBon: a randomised phase II trial of saracatinib versus placebo for cancer-induced bone pain
• Scientific title: SarCaBon: a randomised phase II trial of saracatinib versus placebo for cancer-induced bone pain
• Date of first enrolment: 01/02/2014
• Target sample size: 62
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN60942134
• Study type: Interventional
• Study design: Randomised; Interventional; Design type: Treatment (Treatment)
• Phase: Phase II

Countries of recruitment

United Kingdom

Contacts

• Name: Janet Horsman

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Topic: National Cancer Research Network; Subtopic: All Cancers/Misc Sites; Disease: All
Cancer

Intervention(s)

Saracatinib 125mg per day or placebo for 28 days

Primary Outcome(s)

Pain score: Whether patients? self-reported pain scores are significantly lower after 4 weeks on treatment with

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

2013-002505-62

NCT02085603

15852

Source(s) of Monetary Support

Medical Research Council (MRC) (UK)

Ethics review

Status:
Approval date:
Contact:

First MREC approval date 24/10/2013, ref: 13/YH/0263

Results

• Results available: Yes
• Date Completed: 31/07/2017