FINACCESS - Finnish National Study for Early Access to Cancer Therapies

Overview

Sponsor-declared trial summary

Key facts

Sponsor

HUS-yhtymae

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-05-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the anti-tumor activity and toxicity of anti-cancer drugs that are approved or under review for approval by EMA, FDA or PMDA, or for which otherwise sufficient safety data has been established, and that are used for the treatment of patients with cancer

Secondary objectives 2

1. To perform optional biomarker analyses including (but not limited to) next generation sequencing on fixed and fresh tumor samples or liquid biopsies
2. To define possible pathway activations and resistance mechanism facilitating progression to given therapies

Conditions and MedDRA coding

Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Adult (age ≥18 years) patient with a histologically confirmed cancer.
2. ECOG performance status 0-2
3. Patients must have acceptable organ function as defined below. However, specific inclusion/exclusion criteria specified in the drug-specific study manuals will take precedence: a. Absolute neutrophil count ≥ 1.5 x 109/l b. Hemoglobin ≥ 90 g/l c. Platelets ≥ 75 x 109/l For hematological patients: 3.c. is not applicable for hematological cancers as abnormal blood counts are often caused by advanced disease, and they normalize with successful therapy. d. Total bilirubin ≤ 1.5 x ULN e. AST and ALT < 3 x institutional ULN (or < 5 x ULN in patients with known hepatic metastases) f. Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 40 mL/min/1.73 m2 g. Criteria must be met without growth factor dependency and without packed red blood cell (pRBC) transfusion within last 14 days before screening period.
4. Patients must have objectively evaluable or measurable disease (by physical or radiographic or laboratory examination, according to the RECIST v1.1, Lugano, IWG and ELN-AML, IMWG, RANO, GCIG, iRECIST or PCWG3. Criteria used outside previously listed will be defined separetaly in cohort specific amendment.
5. When drug selection is based on actionable target, molecular profiling of tumor must be analysed in accrediated diagnostic laboratory and results must reveal a potentially actionable variant as defined in Section 5.
6. Ability to understand and the willingness to sign a written or electronic informed consent document and to comply to the protocol.
7. For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
8. Because of the risks of drug treatment to a 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 the 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

Exclusion criteria 8

1. Ongoing toxicity > grade 2, other than alopecia or > grade 1 neuropathy.
2. 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. 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 this study. Palliative radiotherapy for symptom management during the study treatment may be given after the consultation with study sponsor.
3. Patient is pregnant or nursing.
4. 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 study initiation.
5. 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.
6. Patients with known left ventricular ejection fraction (LVEF) < 45% are not eligible.
7. Patients with stroke (including TIA) or acute myocardial infarction within 3 months before the first dose of study treatment are not eligible.
8. 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 with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, drug abuse or severe psychiatric illness/social situations.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To evaluate the anti-tumor activity and toxicity of anti-cancer drugs that are approved or under review for approval by EMA, FDA or PMDA, or for which otherwise sufficient safety data has been established, and are used for the treatment of patients with cancer.

Secondary endpoints 2

1. To perform optional biomarker analyses including (but not limited to) next generation sequencing on fixed and fresh tumor samples or liquid biopsies
2. To define possible pathway activations and resistance mechanism facilitating progression to given therapies

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

HUS-yhtymae

Sponsor organisation

HUS-yhtymae

Address

Stenbackinkatu 9

City

Helsinki

Postcode

00290

Country

Finland

Scientific contact point

Organisation

HUS-yhtymae

Contact name

Katriina Jalkanen, PI

Public contact point

Organisation

HUS-yhtymae

Contact name

Susanna Miettinen, tutkimuskoordinaattori

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications