Patients with a biomarker indicating response to IMP can be included in IMPRESS-Norway. Patients with disease characteristics covered in present indications for the IMP are not eligible.
Conditions
Interventions
Trade Name: Alecensa
Pharmaceutical Form: Capsule, hard
Trade Name: Erivedge
Pharmaceutical Form: Capsule, hard
Trade Name: Phesgo
Pharmaceutical Form: Injection
Trade Name: Rozlytrek
Pharmaceutica
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Molecular profiling: 1. ECOG performance status 0-2. 2. Patients must have measurable or evaluable disease. 3. The patient is, in the opinion of the investigator, a candidate for a treatment cohort in IMPRESS Norway or another clinical study in Norway 4. Ability to understand and the willingness to sign a written informed consent/assent document for molecular profiling Treatment phase: 5. 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. 6. Patients must have acceptable organ function as defined below.: a) Absolute neutrophil count = 1.5 x109 / L b) Hemoglobin > 9 g/dl c) Platelets > 75,000/µl d) Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 800
Exclusion criteria
Exclusion criteria: For molecular profiling: 1. Patients with the following pre-existing cardiac conditions, uncontrolled angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure. 2. Patients with left ventricular ejection fraction (LVEF) known to be 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. 6. Patients with known allergy/hypersensitivity to the study drug (active substance or to any of the excipients). 7. Patients with acute gastrointestinal bleeding within 1 month of start of treatment 8. Patients with stroke (including TIA) or acute myocardial infarction within 4 months before the first dose of study treatment 9. Previous treatment with the selected study drug for the same malignancy. 10. If the patient’s tumour has a genomic variant known to confer resistance to an anti-cancer agent available in this study, the patient will not be eligible to receive that agent but will be eligible to receive other drugs available in this study if all inclusion and exclusion criteria are met for that drug. 11. .Patient is receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g., megestrol acetate, bisphosphonates) or ongoing castration-intent therapy for prostate cancer. These medications must have been started = 1 month prior to enrolment on this study. Patients may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors. 12. Female patients who are pregnant or nursing 13. Patients who do not meet drug-specific eligibility requirements for the drug selected by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • 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. ;Secondary Objective: • To further describe tumour response to treatment • To perform extensive and longitudinal biomarker analyses, including (but not limited to) next generation sequencing (including WGS), on a fresh tumour biopsy specimen and liquid biopsies (blood samples, effusions, CSF for instance). • Mapping of the patient journey through the PCM pipeline • Feasibility of tumour tissue biopsy across and within tumour types ;Primary end point(s): • Percentage of patients that are included and treated based on their molecular tumour profile; • Disease control (objective complete or partial response or stable disease) at 16 weeks after treatment initiation according to established response criteria; • Treatment-related grade =3 and serious adverse events ;Timepoint(s) of evaluation of this end point: Either after 4 year or when the cohort is full depending on the end point. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression-free and overall survival • Duration of time on drug • Time from the molecular diagnostics first informed consent to starting treatment • Estimate the percentage of patients eligible for analyses only by liquid biopsies because • Biopsy is not possible • Primary biopsy is exhausted and re-biopsy is not possible • Explore resistance mechanisms • The impact of tissue type (primary vs. metastases) and liquid biopsy on feasibility (time, procedures, patients welfare and health economy) (within and across tumour types) • Time to initiate therapy • Number of tumour / molecular assessments per patient / cohort ;Timepoint(s) of evaluation of this end point: Either after 4 year or when the cohort is full depending on the end point. | — |
Countries
Norway
Contacts
Public ContactÅslaug Helland
Oslo University Hospital
Outcome results
None listed