Status:
WITHDRAWN
Radical Lung Radiotherapy Plus Nelfinavir
Lead Sponsor:
Oxford University Hospitals NHS Trust
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of this clinical trial is to test whether the drug nelfinavir, which can increase the effectiveness of radiotherapy, can be given safely at the same time as a full dose of radiotherapy for lun...
Eligibility Criteria
Inclusion
- Histologically confirmed NSCLC except bronchoalveolar cancer
- Patients deemed suitable for radical RT according to local policy
- TNM stage T1-2, N0-1, M0 plus patients with local recurrence
- Adequate lung function as defined by protocol
- Age ≥ 18 years
- ECOG performance status 0-2
- Written informed consent
- Patient able and willing to comply with all protocol requirements
Exclusion
- History of other active invasive malignancy (excluding non-melanoma skin cancer and in situ carcinoma of the cervix), where the extent of disease or treatment for that condition may interfere with the study endpoints
- Previous RT to the chest
- Chemotherapy, immunotherapies or investigational medicinal products within 4 weeks of the start of nelfinavir treatment. Ie any neoadjuvant treatment must be completed 4 weeks prior.
- Liver impairment (serum bilirubin ≥ 2 times upper limit of normal, serum AST ≥ 2 times the upper limit of normal)
- Pregnant or breast-feeding women or women of childbearing potential unless effective methods of contraception are used. Contraceptives that contain norethisterone or ethinylestradiol must be replaced by other contraceptive measures
- Concurrent use of contraindicated drugs that cannot be substituted or discontinued 2 weeks or more prior to the start of trial treatment
- Known hypersensitivity to nelfinavir or any of its excipients
- Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01447589
Start Date
February 1 2012
End Date
October 1 2012
Last Update
June 23 2016
Active Locations (1)
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1
Oxford Radcliffe NHS Trust
Oxford, Oxfordshire, United Kingdom, OX3 9DU