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

This study is currently recruiting participants.
Verified May 2017 by Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT02085603
First Posted: March 13, 2014
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
  Purpose
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.

Condition Intervention Phase
Cancer Drug: Saracatinib Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: SarCaBon: A Randomised Phase II Trial of Saracatinib Versus Placebo for Cancer-induced Bone Pain

Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 62
Actual Study Start Date: March 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Saracatinib
Saracatinib at a dose of 125mg orally will be administered daily for four weeks.
Drug: Saracatinib
Placebo Comparator: Placebo
Placebo tablet to be orally administered daily for four weeks.
Drug: Placebo

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: David Andrews, Dr l.a.turner@sheffield.ac.uk

Locations
United Kingdom
Sheffield Teaching Hospitals NHS Trust Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 1SN
Contact: Lesley Turner       l.a.turner@sheffield.ac.uk   
Sub-Investigator: Sarah Danson, Dr         
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
AstraZeneca
Investigators
Principal Investigator: David Andrews, Dr Sheffield Teaching Hospitals NHS Trust
  More Information

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02085603     History of Changes
Other Study ID Numbers: STH16404
2013-002505-62 ( EudraCT Number )
First Submitted: March 11, 2014
First Posted: March 13, 2014
Last Update Posted: May 5, 2017
Last Verified: May 2017

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
advanced solid malignancies

Additional relevant MeSH terms:
Saracatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action