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New treatment option for Advanced Cancer
Official title The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs
ClinicalTrials.gov ID: NCT05159245
What this study is testing
What is Alectinib?
Alectinib is an investigational medicine, being studied as a potential treatment for advanced cancer.
Also referred to as Alecensa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Adult (age \>18 years) patient with a histologically-confirmed locally advanced or metastatic cancer who is no longer benefitting from standard...
- ECOG performance status 0-2
- Patients must have acceptable organ function as defined below. However, specific inclusion/
You likely can't join if
- specified in the drug-specific study manual will take precedence:
- Absolute neutrophil count ≥ 1.5 x 109/l
- Hemoglobin \> 8.0 mmol/l, without blood transfusion within 7 days
- Platelets \> 75 x 109/l (not applicable for hematological patients)
- Total bilirubin \< 1.5 x ULN
- AST and ALT \< 3 x institutional ULN (or \< 5 x ULN in patients with known hepatic metastases)
See the full eligibility criteria
- 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...
- ECOG performance status 0-2
- Patients must have acceptable organ function as defined below. However, specific inclusion/
- specified in the drug-specific study manual will take precedence:
- Absolute neutrophil count ≥ 1.5 x 109/l
- Hemoglobin \> 8.0 mmol/l, without blood transfusion within 7 days
- Platelets \> 75 x 109/l (not applicable for hematological patients)
- Total bilirubin \< 1.5 x ULN
- AST and ALT \< 3 x institutional ULN (or \< 5 x ULN in patients with known hepatic metastases)
- Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 40 mL/min/1.73 m2
- Patients must have objectively evaluable or measurable disease (by physical or radiographic examination, according to RECIST v1.1, Lugano, IWG and ELN-AML, IMWG, RANO, GCIG, iRESIST or PCWG3.
- Results must be available from a tumor molecular profiling. Eligible tests may include any of the following technologies: fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), comparative genomic...
- Patients must have a tumor profile for which treatment with one of the approved (or under revision for approval) targeted anti-cancer drugs included in this study has potential clinical benefit based on preclinical data...
- A new (obtained ≤6 months before inclusion after which no further anti-cancer therapy is allowed) fresh frozen and FFPE tumor biopsy specimen or liquid biopsy for extensive biomarker testing is mandatory before the...
- Ability to understand and the willingness to sign a written informed consent document and comply to the protocol.
- For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
- Because of the risks of drug treatment to the developing fetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the...
- Ongoing toxicity \> grade 2, other than alopecia or \> grade 1 neuropathy.
- Patient is receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement). Required wash out period prior to starting study treatment is at least two weeks. An exception...
- Patients suffering from CRPC are allowed to continue androgen deprivation therapy.
- Medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g., megestrol acetate, bisphosphonates). These medications must have been started ≥ 1 week prior to enrollment on...
- Received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 14 days prior to the first dose of study intervention
- Patient is pregnant or nursing.
- Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient is clinically stable and off steroids for at least 4 weeks prior to...
- Patients with clinically significant preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure are not eligible.
- Patients with clinically significant preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure are not eligible.
- Patients with known left ventricular ejection fraction (LVEF) \< 45% are not eligible
- Patients with stroke (including TIA) or acute myocardial infarction within 3 months before the first dose of study treatment are not eligible
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Turku, Southwest Finland, Finland
- Helsinki, Uusimaa, Finland
- Kuopio, Finland
- Oulu, Finland
- Tampere, Finland
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, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turku, Southwest Finland, Finland; Helsinki, Uusimaa, Finland; Kuopio, Finland; Oulu, Finland; Tampere, Finland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.