Neoac

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Leids Universitair Medisch Centrum (LUMC)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2024-10-07

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

External identifiers

EU CT number

2024-516126-54-00

EudraCT number

2022-001908-17

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

This study aims to increase the number of patients that undergo a successful R0 tumor resection after neo-adjuvant BRAF/MEK inhibitor treatment.

Secondary objectives 1

1. To evaluatue: - Neo-adjuvant and adjuvant treatment related toxicity of dabrafenib/trametinib (according to CTCAE v. 5.0) - 30-day postoperative surgical complications - Histopathological response on neo-adjuvant treatment - Locoregional-free survival - Distant metastasis-free survival - Overall survival Tertiary/exploratory objective(s): To evaluate: - Molecular and immunological responses on dabrafenib/trametinib in ATC

Conditions and MedDRA coding

ANAPLASTIC THYROID CANCER

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 13

1. Informed consent
2. Age over 18 years old.
3. World Health Organization (WHO) Performance Status 0 or I.
4. Histologically confirmed ATC (centrally reviewed).
5. Confirmed presence of BRAFV600E/K mutation in primary tumor tissue.
6. No distant metastases (M0).
7. Free or secured airway
8. Able to swallow pills
9. Patients must have undergone complete disease staging including: PET-CT scan and CT-neck/thorax/abdomen
10. No prior anticancer systemic treatment (including chemotherapy, immunotherapy, oncolytic viral therapy, other systemic therapies).
11. No prior radiotherapy to site of interest
12. Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109/L, Neutrophils ≥ 1.0x109/L, Platelets ≥ 100 x109/L, Hemoglobin ≥ 6.5 mmol/L, AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN, Total bilirubin ≤ 1.5 X ULN, INR and PTT in normal range, LDH < 2xULN. Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula; or estimated glomerular filtration rate > 50 mL/min/1.73m2
13. Absence of additional severe and/or uncontrolled concurrent disease

Exclusion criteria 7

1. No informed consent.
2. History of cancer within 2 years from diagnosis of ATC (exception: basal cell skin cancer, in situ carcinoma).
3. Poorly differentiated transformation of previous differentiated thyroid cancer
4. Presence of distant metastases.
5. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study treatment hazardous or obscure the interpretation of toxicity determination or adverse events.
6. History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes, significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia
7. Pregnancy or nursing

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. This study aims to increase the number of patients that undergo a successful R0 tumor resection after neo-adjuvant BRAF/MEK inhibitor treatment.

Secondary endpoints 1

1. To evaluatue: - Neo-adjuvant and adjuvant treatment related toxicity of dabrafenib/trametinib (according to CTCAE v. 5.0) - 30-day postoperative surgical complications - Histopathological response on neo-adjuvant treatment - Locoregional-free survival - Distant metastasis-free survival - Overall survival

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Leids Universitair Medisch Centrum (LUMC)

Sponsor organisation

Leids Universitair Medisch Centrum (LUMC)

Address

Albinusdreef 2

City

Leiden

Postcode

2333 ZA

Country

Netherlands

Scientific contact point

Organisation

Leids Universitair Medisch Centrum (LUMC)

Contact name

H.W

Public contact point

Organisation

Leids Universitair Medisch Centrum (LUMC)

Contact name

H.W

Locations

1 EU/EEA country · 1 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 11 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