A clinical trial using Saracatinib versus placebo for cancer-induced bone pai

Phase 1

• Conditions: Cancer-induced bone pain; MedDRA version: 19.0Level: LLTClassification code 10049038Term: Metastatic bone painSystem Organ Class: 100000004864; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-002505-62-GB
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-05
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1.Able to give written informed consent and willing to follow the study protocol.
2.Age = 16 years.
3.Cytologically or histologically confirmed solid tumours of known primary site with painful bone metastases and poor control of bone pain
4.WHO performance status = 2
5.Average baseline pain score = 4 and = 9 on a 0-10 numerical scale recorded over at least two separate days
6.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,
7.Ability to take and absorb oral medications.
8.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 spemicide) plus condoms during the study and for 30 days after last dose of saracatinib.
9.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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1.Life expectancy < 3 months.
2.Previous or planned radiotherapy at site of pain.
3.Unstable cardiac disease in last 3 months.
4.History of interstitial lung disease (bilateral, diffuse parenchymal lung disease) in view of known saracatinib-related pneumonitis.
5.Unable to discontinue any medication with known moderate or potent inhibitory effect on CYP3A4, or is a substrate of CYP3A4.
6.Concomitant cytotoxic chemotherapy unless established on maintenance treatment for > 6 weeks (not in a clinical trial).
7.Unable to understand written or spoken English as the primary outcome is dependent on completion of the BPI-SF questionnaire.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified