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

NCT02085603 | Completed Phase 2 DMC

• 2 other identifiers: STH164042013-002505-62
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

advanced solid malignancies

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (5)

• 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

Other Outcomes (1)

• To calculate sample size for future trials

  4 weeks

Study Arms (2)

Saracatinib

ACTIVE COMPARATOR

Saracatinib at a dose of 125mg orally will be administered daily for four weeks.

Drug: Saracatinib

Placebo

PLACEBO COMPARATOR

Placebo tablet to be orally administered daily for four weeks.

Drug: Placebo

Interventions

Saracatinib DRUG

Saracatinib

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• AstraZeneca: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Trust

Sheffield, South Yorkshire, S10 1SN, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

saracatinib

Study Officials

• David Andrews, Dr

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 13, 2014
• Study Start: March 1, 2014
• Primary Completion: January 21, 2018
• Study Completion: January 21, 2018
• Last Updated: April 13, 2018

Record last verified: 2018-04

Locations

GB (1)