Actively Recruiting
The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs
Led by Helsinki University Central Hospital · Updated on 2024-07-15
250
Participants Needed
5
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective non-randomized national clinical phase 2 trial that aims to determine the efficacy and toxicity of targeted anticancer drugs or combinations that are approved or under review by EMA, FDA or PMDA and are used for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic, RNA-molecular or protein expression test.
CONDITIONS
Official Title
The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (age >18 years) patient with a histologically-confirmed locally advanced or metastatic cancer who is no longer benefitting from standard anti-cancer treatment or for whom no such treatment is available or indicated.
- ECOG performance status 0-2
- Acceptable organ function including: absolute neutrophil count ≥ 1.5 x 10^9/l; hemoglobin > 8.0 mmol/l without recent transfusion; platelets > 75 x 10^9/l (not for hematological patients); total bilirubin < 1.5 x upper limit of normal (ULN); AST and ALT < 3 x ULN (< 5 x ULN if hepatic metastases); serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 40 mL/min/1.73 m2
- Objectively evaluable or measurable disease by recognized criteria
- Tumor molecular profiling available from tests like FISH, PCR, CGH, NGS, or IHC showing a potentially actionable variant
- Tumor profile indicating potential clinical benefit from one of the targeted drugs in the study
- New tumor biopsy or liquid biopsy specimen obtained within 6 months before inclusion for biomarker testing
- Ability to understand and sign informed consent and comply with the protocol
- For oral drugs, ability to swallow medication and no known malabsorption syndrome
- Agreement to use adequate contraception during study participation and for 4 months after completion if applicable
You will not qualify if you...
- Ongoing toxicity greater than grade 2 except alopecia or neuropathy grade 1 or less
- Receiving other anti-cancer therapies unless allowed (e.g., continued androgen deprivation therapy for CRPC)
- Received colony-stimulating factors within 14 days before starting study drug
- Pregnant or nursing
- Active progressive brain metastases (clinically stable previously treated brain metastases allowed under conditions)
- Significant preexisting cardiac conditions including uncontrolled angina, arrhythmias, or symptomatic congestive heart failure
- Left ventricular ejection fraction below 45%
- Stroke or acute myocardial infarction within 3 months before starting treatment
- Any other significant medical condition making participation undesirable or compliance difficult as judged by the physician
- Drug-specific inclusion or exclusion criteria may also apply and take precedence
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Turku University Hospital Cancer Centre
Turku, Southwest Finland, Finland
Actively Recruiting
2
Helsinki University Hospital Comprehensive Cancer Center
Helsinki, Uusimaa, Finland, 00029
Actively Recruiting
3
Kuopio University Hospital
Kuopio, Finland
Actively Recruiting
4
Oulu University Hospital OYS Cancer Center
Oulu, Finland
Actively Recruiting
5
Tampere University Hospital Department of Oncology
Tampere, Finland
Actively Recruiting
Research Team
T
Tanja Juslin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
15
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