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

Sponsor
Helsinki University Central Hospital
Study ID
NCT05159245
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Cancer
  • Haematological Malignancy
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Dec 10, 2021
Status verified
Jul 2024
Primary completion
Nov 25, 2026
Completion
Nov 25, 2026

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Alectinib
    For patients with a molecular tumor profile that can potentially be targeted by alectinib.
  • Experimental: Cobimetinib
    For patients with a molecular tumor profile that can potentially be targeted by cobimetinib.
  • Experimental: Vismodegib
    For patients with a molecular tumor profile that can potentially be targeted by vismodegib.
  • Experimental: Trastuzumab+Pertuzumab
    For patients with a molecular tumor profile that can potentially be targeted by trastuzumab+pertuzuma combination.
  • Experimental: Entrectinib
    For patients with a molecular tumor profile that can potentially be targeted by entrectinib.
  • Experimental: Atezolizumab
    For patients with a molecular tumor profile that can potentially be targeted by atezolizumab.
  • Experimental: Vemurafenib
    For patients with a molecular tumor profile that can potentially be targeted by vemurafenib.
  • Experimental: Regorafenib
    For patients with a molecular tumor profile that can potentially be targeted by regorafenib.
  • Experimental: Apalutamide
    For patients with a molecular tumor profile that can potentially be targeted by apalutamide.
  • Experimental: Abemaciclib
    For patients with a molecular tumor profile that can potentially be targeted by abemaciclib.
  • Experimental: Tepotinib
    For patients with a molecular tumor profile that can potentially be targeted by tepotinib.
  • Experimental: Dabrafenib
    For patients with a molecular tumor profile that can potentially be targeted by dabrafenib.
  • Experimental: Trametinib
    For patients with a molecular tumor profile that can potentially be targeted by trametinib.
  • Experimental: Dabrafenib+Trametinib
    For patients with a molecular tumor profile that can potentially be targeted by dabrafenib+trametinib combination.
  • Experimental: Pemigatinib
    For patients with a molecular tumor profile that can potentially be targeted by pemigatinib.

Primary Outcome Measure

Disease control rate [ Time Frame: 16 weeks ]

Central Contacts

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