Actively Recruiting
Improving Public Cancer Care by Implementing Precision Medicine in Norway
Led by Oslo University Hospital · Updated on 2024-02-29
3000
Participants Needed
17
Research Sites
1256 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
H
Haukeland University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
IMPRESS-Norway is a prospective, non-randomized clinical trial evaluating efficacy of commercially available, anti-cancer drugs prescribed for patients with advanced cancer diagnosed with potentially actionable alterations as revealed by molecular diagnostics. IMPRESS-Norway is a nation-wide study and all hospitals with an oncology and / or hematology department will be invited to participate in the study. The study will use a combined umbrella and basket design and a Simon two-stage model of expanding cohorts to follow up potentially effective combinations of biomarker and drug on specific indications. Sampling of biological material will be performed at presentation, during treatment and upon progression. Additional biomarker and translational analyses including whole genome sequencing (WGS) on tumour material and liquid biopsies, identifying mechanisms underlying drug sensitivity versus resistance will be performed.
CONDITIONS
Official Title
Improving Public Cancer Care by Implementing Precision Medicine in Norway
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with pathology-proven locally advanced or metastatic malignant disease no longer benefiting from standard treatment or with no available standard treatment
- ECOG performance status 0 to 2
- Ability to swallow and tolerate oral medication if drug is administered orally
- Acceptable organ function including neutrophil count ≥ 1.5 x10^9/L, hemoglobin > 9 g/dl, platelets > 75,000/µl, bilirubin < 1.5 x institutional upper limit, AST/ALT < 2.5 x upper limit (or < 5 x if hepatic metastases), creatinine clearance ≥ 40 mL/min/1.73 m2
- Measurable or evaluable disease as defined by RECIST v1.1 or appropriate criteria for lymphoma, myeloma, glioblastoma, or immunotherapy cohorts
- Molecular/genomic test showing a potentially targetable profile performed at approved laboratory
- Genomic profile matching potential clinical benefit from approved targeted therapies included in the study
- Meeting drug-specific eligibility criteria
- Women of childbearing potential and men must agree to use effective contraception during and 4-24 months after study
- Negative pregnancy test for women within 1 month prior to inclusion
- Ability and willingness to provide informed consent or assent
You will not qualify if you...
- Eligible for other ongoing trials with equal or better benefit and manageable access
- Ongoing toxicity greater than CTCAE grade 2 related to recent anti-tumor treatment, except peripheral neuropathy
- Peripheral neuropathy grade 3 or higher
- Progressive brain metastases or declining neurological function; treated/stable brain metastases allowed
- For glioblastoma patients, use of enzyme-inducing antiepileptic drugs prohibited
- Pre-existing uncontrolled cardiac conditions or symptomatic congestive heart failure
- Left ventricular ejection fraction below 40%
- Stroke or heart attack within 4 months before treatment
- Acute gastrointestinal bleeding within 1 month before treatment
- Other significant medical conditions that may affect study participation or compliance
- Known allergy or hypersensitivity to study drug or excipients
- Previous treatment with the selected study drug for the same cancer
- Receiving other anti-cancer therapies except certain supportive medications started at least 1 month prior
- Tumor genomic variants conferring resistance to available study drugs
- Pregnant or nursing women
- Not meeting drug-specific eligibility criteria for the selected drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Sykehuset Ålesund
Ålesund, Norway
Not Yet Recruiting
2
Haukeland universitetssykehus
Bergen, Norway
Actively Recruiting
3
Nordlandssykehuset
Bodø, Norway
Actively Recruiting
4
Vestre Viken Hospital
Drammen, Norway
Actively Recruiting
5
Førde Hospital
Førde, Norway
Actively Recruiting
6
Sykehuset Innlandet
Hamar, Norway
Actively Recruiting
7
Helse Fonna
Haugesund, Norway
Not Yet Recruiting
8
Sørlandet sykehus
Kristiansand, Norway
Actively Recruiting
9
Sykehuset Levanger
Levanger, Norway
Not Yet Recruiting
10
Oslo University Hospital
Oslo, Norway, 0379
Actively Recruiting
11
Ahus
Oslo, Norway
Actively Recruiting
12
Sykehuset Telemark
Skien, Norway
Actively Recruiting
13
Stavanger universitetssykehus
Stavanger, Norway
Actively Recruiting
14
Universitetssykehuset i Nord-Norge
Tromsø, Norway
Actively Recruiting
15
St Olavs Hospital
Trondheim, Norway, 2381
Actively Recruiting
16
Sykehuset Vestfold
Tønsberg, Norway
Not Yet Recruiting
17
Sykehuset Østfold Kalnes
Fredrikstad, Østfold fylke, Norway
Actively Recruiting
Research Team
Å
Åslaug Helland, MD PhD
CONTACT
G
Gro LIve Fagereng, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
20
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here