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 : Completed
First Posted : March 13, 2014
Last Update Posted : April 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: Saracatinib Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 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|
|Actual Primary Completion Date :||January 21, 2018|
|Actual Study Completion Date :||January 21, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085603
|Sheffield Teaching Hospitals NHS Trust|
|Sheffield, South Yorkshire, United Kingdom, S10 1SN|
|Principal Investigator:||David Andrews, Dr||Sheffield Teaching Hospitals NHS Trust|