CancerPhase 2SarCaBonNCT02085603
SarCaBon: A Randomised Phase II Trial of Saracatinib Versus Placebo for Cancer-induced Bone Pain
A Phase 2 study testing Saracatinib in people with Cancer, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Saracatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to 21 Jan 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Trust
Sheffield, South Yorkshire, S10 1SN
About this study
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.
Read the 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
- Being tested
- Saracatinib, Placebo
- Keywords
- advanced solid malignancies
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaracatinibDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Saracatinib | Active comparator | Saracatinib at a dose of 125mg orally will be administered daily for four weeks. Receives: Drug: Saracatinib |
| Placebo | Placebo comparator | Placebo tablet to be orally administered daily for four weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is pain score lower after 4 weeks on treatment?
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.
Measured: 4 weeks
Secondary outcomes (5)
Does analgesic drug usage decreases when patients take saracatinib?
To determine if analgesic drug usage decreases when patients take saracatinib.
Measured: 4 weeks
Does pain increase after treatment
To determine if pain thresholds at symptomatic sites increase after treatment with saracatinib.
Measured: 4 weeks
Does symptoms and quality of life improve after treatment?
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.
Measured: 4 weeks
Is bone turnover further reduced by saracatinib?
To determine whether bone turnover is further reduced by saracatinib in patients already taking bisphosphonates or denosumab.
Measured: 4 weeks
Safety of treatment
To determine the safety of saracatinib in this population by documenting adverse events and compliance.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion21 Jan 2018
- Study completion21 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- David Andrews, Dr, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085603
- Sponsor's protocol ID
- STH16404
- Other IDs
- 2013-002505-62
- Acronym
- SarCaBon
- Status last verified
- Apr 2018
- First submitted
- 11 Mar 2014
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SarCaBon: A Randomised Phase II Trial of Saracatinib Versus Placebo for Cancer-induced Bone Pain
- ClinicalTrials.gov ID
- NCT02085603
- Acronym / sponsor ID
- SarCaBon / STH16404
- Conditions
- Cancer
- Keywords
- advanced solid malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Mar 2014 (actual)
- Primary completion
- 21 Jan 2018 (actual)
- Study completion
- 21 Jan 2018 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saracatinib | Active comparator | Drug: SaracatinibSaracatinib at a dose of 125mg orally will be administered daily for four weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet to be orally administered daily for four weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saracatinib | Drug | Saracatinib |
| Placebo | Drug | Placebo |
Primary outcome
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.
5 secondary outcomes
Does analgesic drug usage decreases when patients take saracatinib?
Time frame: 4 weeks
Does pain increase after treatment
Time frame: 4 weeks
Does symptoms and quality of life improve after treatment?
Time frame: 4 weeks
Is bone turnover further reduced by saracatinib?
Time frame: 4 weeks
Safety of treatment
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Andrews, Dr principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Saracatinib in people with Cancer, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is pain score lower after 4 weeks on treatment? (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.