Cancer-induced bone pain MedDRA version: 19.0 Level: LLT Classification code 10049038 Term: Metastatic bone pain System Organ Class: 100000004864
Conditions
Interventions
Product Name: Saracatinib
Product Code: AZD0530
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Saracatinib
CAS Number: 379231-04-6
Current Sponsor code: AZD0530
Concentration unit: mg mi
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion 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 a 0-10 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. pre-menopausal females, females who have been menopausal for =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1.Life expectancy 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 BPI-SF questionnaire.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is Saracatinib effective at reducing bone pain in cancer patients that have painful bone metastases by comparing patient’s self-reported pain ratings (0 – 10 point scale) after 4 weeks on treatment with pain scores from patients who receive placebo.;Secondary Objective: 1 Does concomitant analgesic usage decrease when patients are on Saracatinib? 2.Do pain thresholds at symptomatic sites increase after treatment with Saracatinib? 3.Are pain-related symptoms and quality of life improved by saracatinib as shown using the BPI, QLQ-C30, BM-22 and GAPR questionnaires? 4.Is bone turnover further reduced by Saracatinib in patients already taking bisphosphonates or denosumab? 5.Is saracatinib use safe and acceptable in this patient population? 6.Is capturing patient reported outcomes using a telephone based interactive voice response system acceptable to this group of patients? ;Primary end point(s): The primary outcome will be whether the patients self-reported pain score is significantly lower than placebo after 4 weeks on treatment with saracatinib. ;Timepoint(s) of evaluation of this end point: Target: Aug 2017 (Final Data Collection date for primary outcome measure) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.To determine if analgesic drug usage decreases when patients take saracatinib. 2.To determine if pain thresholds at symptomatic sites increase after treatment with saracatinib. 3.To determine if pain-related symptoms and quality of life are improved by saracatinib using the BPI, EORTC QLQ-C30, EORTC BM-22 and GAPR questionnaires. 4.To determine whether bone turnover is further reduced by saracatinib in patients already taking bisphosphonates or denosumab. 5.To determine the safety of saracatinib in this population by documenting a ;Timepoint(s) of evaluation of this end point: Target: Aug 2017 (Final Data Collection date for primary outcome measure) | — |
Countries
United Kingdom
Contacts
Public ContactAimee Card
Sheffield Teaching Hospitals NHS Foundation Trust
Outcome results
None listed