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The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

ConditionsAdvanced CancerSolid TumorHaematological Malignancy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorHelsinki University Central Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Patients must have acceptable organ function as defined below. However, specific inclusion/

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Alectinib

    Drug

    ALK

  • Cobimetinib

    Drug

    MEK1, MEK2

  • Vismodegib

    Drug

    Hedgehog

  • Trastuzumab+Pertuzumab

    Drug

    HER2

  • Entrectinib

    Drug

    NTRK/ ROS1, ALK

  • Atezolizumab

    Drug

    PD-L1

  • Vemurafenib

    Drug

    BRAF V600

  • Regorafenib

    Drug

    KIT/BRAF, RET

  • Apalutamide

    Drug

    AR

  • Abemaciclib

    Drug

    CDK4/6

  • Tepotinib

    Drug

    MET ex14

  • Dabrafenib

    Drug

    RAF

  • Trametinib

    Drug

    MEK1, MEK2

  • Dabrafenib+Trametinib

    Drug

    RAF, MEK1, MEK2

  • Pemigatinib

    Drug

    FGFR2

Treatment groups

250 Participants
are divided into 15 treatment groups

15

Treatment groups

See each treatment group below.

Group A: AlectinibExperimental treatment 1 intervention
Group B: CobimetinibExperimental treatment 1 intervention
Group C: VismodegibExperimental treatment 1 intervention
Group D: Trastuzumab+PertuzumabExperimental treatment 1 intervention
Group E: EntrectinibExperimental treatment 1 intervention
Group F: AtezolizumabExperimental treatment 1 intervention
Group G: VemurafenibExperimental treatment 1 intervention
Group H: RegorafenibExperimental treatment 1 intervention
Group I: ApalutamideExperimental treatment 1 intervention
Group J: AbemaciclibExperimental treatment 1 intervention
Group K: TepotinibExperimental treatment 1 intervention
Group L: DabrafenibExperimental treatment 1 intervention
Group M: TrametinibExperimental treatment 1 intervention
Group N: Dabrafenib+TrametinibExperimental treatment 1 intervention
Group O: PemigatinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Disease control rate

Disease control rate at 16 weeks after treatment initiation (defined as patients by CR, PR, SD)

Time frame
16 weeks

Secondary outcomes

1

Duration of treatment

Time on drug

Time frame
5 years
2

Adverse Events

Treatment-related grade ≥3 and serious adverse events

Time frame
5 years
3

Overall response

Best overall response (defined as patients by CR, PR, SD)

Time frame
5 years
4

PFS

Progression free survival

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helsinki University Central Hospital

Lead sponsor

Source ClinicalTrials.gov
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