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

INTERVENTION: Saracatinib 125mg per day or placebo for 28 days CONDITION: Topic: National Cancer Research Network; Subtopic: All Cancers/Misc Sites; Disease: All ; Cancer PRIMARY OUTCOME: Pain score: Whether patients? self‐reported pain scores are significantly lower after 4 weeks on treatment with SECONDARY OUTCOME: Not provided at time of registration 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 trea