Improving public cancer care by implementing precision medicine in Norway

Phase 1

• Conditions: 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.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-004414-35-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-23
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

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 < 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
7. For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
8. Results must be available from a genomic / molecular test performed in a preapproved laboratory. 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. 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.
9. Have a genomic profile for which treatment with one of the approved targeted anti-cancer therapies included in this study has potential clinical benefit.
10. Because of the risks of drug treatment to the developing fetus, women of child-bearing potential and men must agree to use adequate highly effective methods of contraception for the duration of study participation, and for 4 to 24 months following completion of study therapy as defined.
11. Female participants must have a negative highly sensitive pregnancy test <1 month prior to inclusion.
12. Male patients should avoid impregnating a female partner. Male study patients must agree to one of the following: practice effective barrier contraception as described during the entire study treatment period and through a certain time after the last dose of study drug. Details are given in the Drug specific amendment”.
13. Ability to understand and the willingness to sign a written informed consent/assent document for treatment as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Guardians / parents can act on behalf of children.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 800

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 < 40%.
3. Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, severe psychiatric illness situations, or anticipated or planned anti-cancer treatment or surgery.
Patients with known progressive brain metastases determined by serial imaging or declining neurologic function in the opinion of the treating physician. Patients with previously treated / stable brain metastases are eligible. Additional exclusion criteria specific for GBM patients:. Patients who require anti-convulsant therapy must be taking non-enzyme inducing antiepileptic drugs (non-EIAED). EIAED are prohibited. Patients previously on EIAED must be switched to non-EIAED at least 2 weeks prior to randomization.
Treatment phase:
4. 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 whom access to the ongoing trials is manageable (taking geography into consideration).
5. 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.
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified