SarCaBon: A Randomised Phase II Trial of Saracatinib Versus Placebo for Can... | Recruiting
SarCaBon: A Randomised Phase II Tri... | Recruiting
SarCaBon: A Randomised Phase II Trial of Saracatinib Versus Placebo for Cancer-induced Bone Pain
SarCaBon

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Medical Conditions
  • Cancer
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02085603
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
  • 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.
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Saracatinib, Drug : Placebo

Study Arm Groups : Saracatinib, Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
    Is pain score lower after 4 weeks on treatment?; 4 weeks
Secondary Outcome Measures
    Does analgesic drug usage decreases when patients take saracatinib?; 4 weeks; Does pain increase after treatment; 4 weeks; Does symptoms and quality of life improve after treatment?; 4 weeks; Is bone turnover further reduced by saracatinib?; 4 weeks; Safety of treatment; 4 weeks
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
16 Years - N/A
Who Can Participate
Patients
Number of Participants
62
Participant Inclusion Criteria
    Inclusion Criteria:

    - Able to give written informed consent and willing to follow the study protocol.

    - Age ≥ 16 years.

    - Cytologically or histologically confirmed solid tumours of known primary site or multiple myeloma with painful bone metastases and poor control of bone pain in spite of pain medication including opioids

    - WHO performance status ≤ 2

    - Baseline BPI-SF score for pain on average ≥ 4 and ≤ 9 on a 0-10 numerical scale recorded on at least two separate days using the BPI-SF

    - 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

    - Ability to take and absorb oral medications.

    - Female patients of childbearing potential (i.e. pre-menopausal 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 spermicide) plus condoms during the study and for 30 days after last dose of saracatinib.

    - Male patients with a partner of child-bearing 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:

    - Life expectancy < 3 months.

    - Previous or planned radiotherapy at site of pain.

    - Unstable cardiac disease in last 3 months.

    - History of interstitial lung disease (bilateral, diffuse parenchymal lung disease) in view of known saracatinib-related pneumonitis.

    - Unable to discontinue any medication with known moderate or potent inhibitory effect on CYP3A4, or or is a substrate of CYP3A4.

    - Concomitant cytotoxic chemotherapy unless established on maintenance treatment for > 6 weeks (not in a clinical trial).

    - Unable to understand written or spoken English as the primary outcome is dependent on completion of the BPI-SF questionnaire.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Sheffield Teaching Hospitals NHS Trust
Sheffield
South Yorkshire
S10 1SN
Trial Contact(s)
Primary Trial Contact
David Andrews, Dr
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
SarCaBon: A Randomised Phase II Trial of Saracatinib Versus Placebo for Cancer-induced Bone Pain
EudraCT Number
Not available for this trial
Funder(s)
  • AstraZeneca
Other Study ID Numbers
STH16404
Sponsor(s)
Sheffield Teaching Hospitals NHS Foundation Trust
Key Dates

Recruitment Start Date

Mar 2014

Recruitment End Date

Jan 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

11 Mar 2014

Date updated in source

04 May 2017