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

NCT05159245 | Recruiting Phase 2

• 1 other identifier: FINPROVE
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Advanced Cancer; Solid Tumor; Haematological Malignancy

Keywords

DRUP study

Outcome Measures

Primary Outcomes (1)

• Disease control rate

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

  16 weeks

Secondary Outcomes (5)

• Duration of treatment

  5 years

• Adverse Events

  5 years

• Overall response

  5 years

• PFS

  5 years

• OS

  5 years

Study Arms (15)

Alectinib

EXPERIMENTAL

For patients with a molecular tumor profile that can potentially be targeted by alectinib.

Drug: Alectinib

Cobimetinib

EXPERIMENTAL

For patients with a molecular tumor profile that can potentially be targeted by cobimetinib.

Drug: Cobimetinib

Vismodegib

EXPERIMENTAL

For patients with a molecular tumor profile that can potentially be targeted by vismodegib.

Drug: Vismodegib

Trastuzumab+Pertuzumab

EXPERIMENTAL

For patients with a molecular tumor profile that can potentially be targeted by trastuzumab+pertuzuma combination.

Drug: Trastuzumab+Pertuzumab

Entrectinib

EXPERIMENTAL

For patients with a molecular tumor profile that can potentially be targeted by entrectinib.

Drug: Entrectinib

Atezolizumab

EXPERIMENTAL

For patients with a molecular tumor profile that can potentially be targeted by atezolizumab.

Drug: Atezolizumab

Vemurafenib

EXPERIMENTAL

For patients with a molecular tumor profile that can potentially be targeted by vemurafenib.

Drug: Vemurafenib

Regorafenib

EXPERIMENTAL

For patients with a molecular tumor profile that can potentially be targeted by regorafenib.

Drug: Regorafenib

Apalutamide

EXPERIMENTAL

For patients with a molecular tumor profile that can potentially be targeted by apalutamide.

Drug: Apalutamide

Abemaciclib

EXPERIMENTAL

For patients with a molecular tumor profile that can potentially be targeted by abemaciclib.

Drug: Abemaciclib

Tepotinib

EXPERIMENTAL

For patients with a molecular tumor profile that can potentially be targeted by tepotinib.

Drug: Tepotinib

Dabrafenib

EXPERIMENTAL

For patients with a molecular tumor profile that can potentially be targeted by dabrafenib.

Drug: Dabrafenib

Trametinib

EXPERIMENTAL

For patients with a molecular tumor profile that can potentially be targeted by trametinib.

Drug: Trametinib

Dabrafenib+Trametinib

EXPERIMENTAL

For patients with a molecular tumor profile that can potentially be targeted by dabrafenib+trametinib combination.

Drug: Dabrafenib+Trametinib

Pemigatinib

EXPERIMENTAL

For patients with a molecular tumor profile that can potentially be targeted by pemigatinib.

Drug: Pemigatinib

Interventions

Trametinib DRUG

MEK1, MEK2

Also known as: Mekinist

Trametinib

Dabrafenib+Trametinib DRUG

RAF, MEK1, MEK2

Also known as: Tafinlanr+Mekinist

Dabrafenib+Trametinib

Pemigatinib DRUG

FGFR2

Also known as: Pemazyre

Pemigatinib

Alectinib DRUG

ALK

Also known as: Alecensa

Alectinib

Cobimetinib DRUG

MEK1, MEK2

Also known as: Cotellic

Cobimetinib

Vismodegib DRUG

Hedgehog

Also known as: Erivedge

Vismodegib

Trastuzumab+Pertuzumab DRUG

HER2

Also known as: Phesgo

Trastuzumab+Pertuzumab

Entrectinib DRUG

NTRK/ ROS1, ALK

Also known as: Rozlytrek

Entrectinib

Atezolizumab DRUG

PD-L1

Also known as: Tecentriq

Atezolizumab

Vemurafenib DRUG

BRAF V600

Also known as: Zelboraf

Vemurafenib

Regorafenib DRUG

KIT/BRAF, RET

Also known as: Stivarga

Regorafenib

Apalutamide DRUG

AR

Also known as: Erleada

Apalutamide

Abemaciclib DRUG

CDK4/6

Also known as: Verzenio

Abemaciclib

Tepotinib DRUG

MET ex14

Also known as: Tepmetko

Tepotinib

Dabrafenib DRUG

RAF

Also known as: Tafinlar

Dabrafenib

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 hybridization (CGH), next generation sequencing (NGS) or immunohistochemistry (IHC). The test may have been performed on the primary tumor or a metastatic lesion, in a diagnostic laboratory or within the context of another commercial platform (eg Foundation Medicine), and must reveal a potentially actionable variant.
• 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 or clinical information.
• 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 duration of study participation, and for four months following completion of study therapy. Male patients should avoid impregnating a female partner. Male patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or completely abstain from sexual intercourse.
• 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 is made for:
• Patients suffering from CRPC are allowed to continue androgen deprivation therapy.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (5)

Turku University Hospital Cancer Centre

Turku, Southwest Finland, Finland

RECRUITING

Helsinki University Hospital Comprehensive Cancer Center

Helsinki, Uusimaa, 00029, Finland

RECRUITING

Kuopio University Hospital

Kuopio, Finland

RECRUITING

Oulu University Hospital OYS Cancer Center

Oulu, Finland

RECRUITING

Tampere University Hospital Department of Oncology

Tampere, Finland

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

alectinib; cobimetinib; HhAntag691; entrectinib; atezolizumab; Vemurafenib; regorafenib; apalutamide; abemaciclib; tepotinib; dabrafenib; trametinib; pemigatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Katriina Jalkanen, MD, PhD

  Helsinki University Hospital Comprehensive Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanja Juslin

CONTACT

+358405597415; tanja.juslin@hus.fi

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 16, 2021
• Study Start: December 10, 2021
• Primary Completion (Estimated): November 25, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2026-2027
• Access Criteria: Will be made available through European regulatory CTIS programme.

Locations

FI (5)