Off-label Use of Anti-cancer Drugs in Norway -a Prospective Cohort Study

STATUS

Recruiting
End date

Dec 31, 2027
participants needed

200
sponsor

Oslo University Hospital

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Updated on 19 February 2024

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cancer

cancer diagnosis

antineoplastic agents

off label use

Summary

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Off-label drug use, where a marketed drug is used outside its approved indication, may allow early access to new and promising treatments. However, its use can be a source of controversy, due to limited evidence for clinical benefit and lack of cost/QALY-estimates, leading to challenging prioritization issues. The number of drugs suitable for off-label use is expected to further increase in the coming years, owing to the rapid progress in the field of oncology, in particular with the current era of precision medicine and targeted therapies. This also challenges the traditional method of running clinical trials, with eligible patient populations commonly being small, underpinning the importance of gaining supplementary real-world evidence from well performed observational studies.

This prospective observational study will therefore assess real-world outcomes of patients treated with off-label anti-cancer drugs, including efficacy in terms of response rates, time to progression/relapse measures and survival; patient-reported outcome measures (PROMS) and self-reported side-effects/toxicity; as well as collecting blood samples for a biobank for further translational research. Further, the study will give a descriptive analysis of the current practice of off-label use of anti-cancer drugs in Norway, including prevalence estimation and health care related cost analyses.

Details

Condition	Cancer
Age	18years - 100years
Clinical Study Identifier	NCT04457713
Sponsor	Oslo University Hospital
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Verified cancer diagnosis (based on radiological, histological/cytological or operative evidence)
	Treatment with off-label anti-cancer drug
	Age 18 years
	Able to provide written informed consent
Exclusion Criteria
	None

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Off-label Use of Anti-cancer Drugs in Norway -a Prospective Cohort Study