SarCaBon: A Randomised Phase II Trial of Saracatinib Versus Placebo for Cancer-induced Bone Pain (SarCaBon)
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|ClinicalTrials.gov Identifier: NCT02085603|
Recruitment Status : Recruiting
First Posted : March 13, 2014
Last Update Posted : May 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: Saracatinib Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||SarCaBon: A Randomised Phase II Trial of Saracatinib Versus Placebo for Cancer-induced Bone Pain|
|Actual Study Start Date :||March 2014|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||March 2018|
Active Comparator: Saracatinib
Saracatinib at a dose of 125mg orally will be administered daily for four weeks.
Placebo Comparator: Placebo
Placebo tablet to be orally administered daily for four weeks.
- Is pain score lower after 4 weeks on treatment? [ Time Frame: 4 weeks ]The primary outcome will be whether the patient's self-reported pain score is significantly lower after 4 weeks on treatment with saracatinib than after placebo.
- Does analgesic drug usage decreases when patients take saracatinib? [ Time Frame: 4 weeks ]To determine if analgesic drug usage decreases when patients take saracatinib.
- Does pain increase after treatment [ Time Frame: 4 weeks ]To determine if pain thresholds at symptomatic sites increase after treatment with saracatinib.
- Does symptoms and quality of life improve after treatment? [ Time Frame: 4 weeks ]To determine if pain-related symptoms and quality of life are improved by saracatinib using the BPI-SF, EORTC QLQ-C30, EORTC BM-22 and GAPR questionnaires.
- Is bone turnover further reduced by saracatinib? [ Time Frame: 4 weeks ]To determine whether bone turnover is further reduced by saracatinib in patients already taking bisphosphonates or denosumab.
- Safety of treatment [ Time Frame: 4 weeks ]To determine the safety of saracatinib in this population by documenting adverse events and compliance.
- To calculate sample size for future trials [ Time Frame: 4 weeks ]To resolve practical issues for the conduct of a future phase III RCT, such as the magnitude of the effect and its variability across the sample population, recruitment and attrition rates; and to inform the sample size calculation for a definitive trial.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085603
|Contact: David Andrews, Drfirstname.lastname@example.org|
|Sheffield Teaching Hospitals NHS Trust||Recruiting|
|Sheffield, South Yorkshire, United Kingdom, S10 1SN|
|Contact: Lesley Turner email@example.com|
|Sub-Investigator: Sarah Danson, Dr|
|Principal Investigator:||David Andrews, Dr||Sheffield Teaching Hospitals NHS Trust|