Improving public cancer care by implementing precision medicine in Norway
EU CTIS ID: 2023-507894-16-00
What this study is testing
To describe the anti-tumour activity and toxicity of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced malignancy that harbours a genomic- or protein expression variant known to be a drug target or to predict sensitivity to a drug. To facilitate patient access to commercially available, targeted anti-cancer drugs of potential efficacy for treatment of an advanced malignancy that harbours a genomic or protein expression variant known to be a drug target or to predict sensitivity to a drug.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ECOG performance status 0-2
- Life expectancy minimum 3 months
- Patient with a pathology-proven locally advanced or metastatic malignant disease who is no longer benefitting from standard anti-cancer treatment or for whom, in the opinion of the investigator, no such treatment is available or indicated.
- Patients must have acceptable organ function as defined below (exceptions for haematological diagnoses): a) Absolute neutrophil count ≥ 1.5 x109 / L b) Hemoglobin > 9 g/dl c) Platelets > 75,000/µl d) Total bilirubin < 1.5 x institutional upper limit of normal (ULN) e) AST (SGOT) and ALT(SGPT) < 2.5 x institutional upper limit of normal (ULN) (or < 5 x ULN in patients with known hepatic metastases) f) Calculated or measured creatinine clearance ≥ 40 mL/min/1.73 m2
- For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
- Results must be available from a genomic / molecular test performed in a preapproved laboratory (Section 10.1). The test used to qualify a patient for participation in IMPRESS-Norway may have been performed on any specimen of the patient’s tumour obtained at any point during the patient’s care at the discretion of the patient’s treating physician. Genomic assays performed on cell-free DNA in plasma (“liquid biopsies”) will also be acceptable if the genomic analysis is performed as defined in Section 10.5. NGS analyses will be performed on a newly sampled biopsy if possible. Information from these analyses might be used upon progression, for evaluation of possible new cohort-inclusion.
You likely can't join if
- Patients eligible to enter other ongoing trials which have the potential to benefit the patients equally or more than a IMPRESS-Norway cohort, and for
- Ongoing toxicity > CTCAE grade 2, other than peripheral neuropathy, related to anti-tumour treatment that was completed within 4 weeks prior to treatment initiation. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3.Patients with known allergy/hypersensitivity to the study drug (active substance or to any of the excipients).
- Patients with acute gastrointestinal bleeding within 1 month of start of treatment
- Patients with stroke (including TIA) or acute myocardial infarction within 4 months before the first dose of study treatment
See the full eligibility criteria
- ECOG performance status 0-2
- Life expectancy minimum 3 months
- Patient with a pathology-proven locally advanced or metastatic malignant disease who is no longer benefitting from standard anti-cancer treatment or for whom, in the opinion of the investigator, no such treatment is available or indicated.
- Patients must have acceptable organ function as defined below (exceptions for haematological diagnoses): a) Absolute neutrophil count ≥ 1.5 x109 / L b) Hemoglobin > 9 g/dl c) Platelets > 75,000/µl d) Total bilirubin < 1.5 x institutional upper limit of normal (ULN) e) AST (SGOT) and ALT(SGPT) < 2.5 x institutional upper limit of normal (ULN) (or < 5 x ULN in patients with known hepatic metastases) f) Calculated or measured creatinine clearance ≥ 40 mL/min/1.73 m2
- For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
- Results must be available from a genomic / molecular test performed in a preapproved laboratory (Section 10.1). The test used to qualify a patient for participation in IMPRESS-Norway may have been performed on any specimen of the patient’s tumour obtained at any point during the patient’s care at the discretion of the patient’s treating physician. Genomic assays performed on cell-free DNA in plasma (“liquid biopsies”) will also be acceptable if the genomic analysis is performed as defined in Section 10.5. NGS analyses will be performed on a newly sampled biopsy if possible. Information from these analyses might be used upon progression, for evaluation of possible new cohort-inclusion.
- Have a genomic profile for which treatment with one of the approved targeted anti-cancer therapies included in this study has potential clinical benefit
- Patients eligible to enter other ongoing trials which have the potential to benefit the patients equally or more than a IMPRESS-Norway cohort, and for
- Ongoing toxicity > CTCAE grade 2, other than peripheral neuropathy, related to anti-tumour treatment that was completed within 4 weeks prior to treatment initiation. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3.Patients with known allergy/hypersensitivity to the study drug (active substance or to any of the excipients).
- Patients with acute gastrointestinal bleeding within 1 month of start of treatment
- Patients with stroke (including TIA) or acute myocardial infarction within 4 months before the first dose of study treatment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.