ISRCTN60942134CompletedPhase 2
SarCaBon: a randomised phase II trial of saracatinib versus placebo for cancer-induced bone pain
Sheffield Teaching Hospitals NHS Trust (UK)0 sites13 target enrollmentStarted: January 30, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 13
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
Investigators
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