Using anti-cancer drugs for unapproved purposes in Norway
Off-label Use of Anti-cancer Drugs in Norway -a Prospective Cohort Study
This study looks at how well off-label anti-cancer drugs work for people with cancer in Norway to see if they help improve their treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT04457713 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the real-world outcomes of patients with cancer who are treated with off-label anti-cancer drugs. It focuses on assessing the efficacy of these treatments in terms of response rates and time to progression or relapse. By collecting data from patients receiving these drugs, the study seeks to provide valuable insights into their effectiveness and safety, contributing to the growing body of evidence in oncology. The study is particularly relevant in the context of precision medicine and the increasing number of drugs available for off-label use.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a verified cancer diagnosis who are being treated with off-label anti-cancer drugs.
Not a fit: Patients who are not receiving off-label anti-cancer treatments or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical evidence on the effectiveness of off-label anti-cancer treatments, potentially improving patient outcomes.
How similar studies have performed: Other observational studies have shown success in evaluating off-label drug use, indicating that this approach is both relevant and necessary in the current medical landscape.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Knut Smeland, PhD/MD — Oslo University Hospital
- Study coordinator: Knut Smeland, PhD/MD
- Email: knusme@ous-hf.no
- Phone: +4722934000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.