NCT02085603

SarCaBon: A Randomised Phase II Trial of Saracatinib Versus Placebo for Cancer-induced Bone Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess whether a drug called Saracatinib is helpful in controlling bone pain from cancer. The investigators do not know if it will be, so half of the patients in the study will receive the drug and half will get placebo. Saracatinib is a drug that has been tried in patients with many different forms of cancer. It seems to have effects in bone and so the investigators hope that it will have an effect in those with cancer that has spread to the bones.

Detailed description

Controlling cancer pain in cancer patients can be very difficult as not all cancers respond to radiotherapy or chemotherapy and sometimes the sideeffects of strong painkillers, like morphine, can limit the dose of drug that can be given. The investigators have some evidence that a molecule called Src is involved in the development of cancer-induced bone pain. This study will use a drug, saracatinib that targets Src and will see if giving it to patients can reduce pain from cancer in the bones. The investigators will compare saracatinib to a placebo over a 4 week period in an estimated 62 patients. The investigators will measure whether the pain that patients report is less with saracatinib than placebo. The investigators will also measure how many painkillers people are taking before and after saracatinib/placebo, if pain thresholds have changed, if pain-related symptoms and quality of life have been improved and if saracatinib has a direct effect on the rate at which cancer breaks down bone.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Saracatinib
DRUG	Placebo

Timeline

• Start date: 2014-03-01
• Primary completion: 2018-01-21
• Completion: 2018-01-21
• First posted: 2014-03-13
• Last updated: 2018-04-13

Locations

1 site across 1 country: United Kingdom