NCT05159245

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

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs to Determine the Efficacy in Treatment of Advanced Cancers With a Known Molecular Profile

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a prospective non-randomized clinical 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. The study also aims to facilitate patient access to approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies and to perform next generation sequencing and further deeper analysis on tumor biopsies and/or liquid biopsies for biomarker analyses and resistance mechanisms. Eligible patients have an advanced cancer for which standard treatment options no longer exist and acceptable performance status and organ function. A tumour DNA, RNA or protein expression analysis is required and the results must identify at least one potentially actionable molecular variant as defined in the protocol. Molecular profiling will be utilized to determine an appropriate drug(s) from among those available in the protocol. Drug selection will be guided by a list of potential profiles, the molecular tumor board and databases of identified targets for review and approval of the recommended treatment. The protocol-specified treatment will be administered to the patient once any drug- and disease specific eligibility criteria and overall study criteria are met. Data for standard efficacy outcomes including tumor response, progression-free and overall survival as well as duration of treatment will be collected for all patients receiving treatment within the trial. In addition, treatment related toxicity will be collected according to CTCAE 5.0.

Conditions

• Advanced Cancer
• Solid Tumor
• Haematological Malignancy

Interventions

Type	Name	Description
DRUG	Alectinib	ALK
DRUG	Cobimetinib	MEK1, MEK2
DRUG	Vismodegib	Hedgehog
DRUG	Trastuzumab+Pertuzumab	HER2
DRUG	Entrectinib	NTRK/ ROS1, ALK
DRUG	Atezolizumab	PD-L1
DRUG	Vemurafenib	BRAF V600
DRUG	Regorafenib	KIT/BRAF, RET
DRUG	Apalutamide	AR
DRUG	Abemaciclib	CDK4/6
DRUG	Tepotinib	MET ex14
DRUG	Dabrafenib	RAF
DRUG	Trametinib	MEK1, MEK2
DRUG	Dabrafenib+Trametinib	RAF, MEK1, MEK2
DRUG	Pemigatinib	FGFR2

Timeline

• Start date: 2021-12-10
• Primary completion: 2026-11-25
• Completion: 2026-11-25
• First posted: 2021-12-16
• Last updated: 2024-07-15

Locations

5 sites across 1 country: Finland