Molecularly Tailored Therapy versus Standard Care in Advanced Pancreatic Cancer

Status Authorised, recruitment pending · 1 EU/EEA countries · 4 sites · Protocol PA 2506

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Authorised, recruitment pending

Participants planned 1,200

Countries 1

Sites 4

Advanced pancreatic cancer

To compare the efficacy of molecularly tailored therapy versus standard of care in patients with pancreatic cancer with actionable reimbursed druggable molecular alterations as measured by progression-free survival

Key facts

Sponsor: Region Hovedstaden
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Decision date (initial): 2026-05-18
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: Danish Center for Clinical Cancer Research

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

Secondary objectives 3

To compare the efficacy of molecularly tailored therapy versus standard of care in patients with PC with actionable reimbursed druggable molecular alterations as in terms of median OS, OS rate at 6 and 12 months, ORR, DCR, and DOR- To compare the efficacy of molecularly tailored therapy versus standard of care in patients with PC with actionable reimbursed druggable molecular alterations as in terms of median OS, OS rate at 6 and 12 months, ORR, DCR, and DOR
To compare the safety and tolerability of molecularly tailored therapy versus standard of care in patients with PC with actionable reimbursed druggable molecular alterations.
To assess the quality-of-life in patients with PC with actionable reimbursed druggable molecular alterations

Conditions and MedDRA coding

Advanced pancreatic cancer

Version	Level	Code	Term	System organ class
21.0	LLT	10033607	Pancreatic cancer recurrent	10029104
27.0	LLT	10033605	Pancreatic cancer metastatic	10029104
21.0	LLT	10033606	Pancreatic cancer non-resectable	10029104
21.0	LLT	10033604	Pancreatic cancer	10029104

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

Adult patients (aged 18 and over)
Pancreatic cancer confirmed by cytology or histology
Written informed consent before any specific study procedures
Available personalized report communicating the molecular testing results and detailed treatment options
Participants must have received and progressed during or after 1 line of systemic chemotherapy in the advanced setting (gemcitabine or 5-FU based regimens) or within one year of the adjuvant/neoadjuvant treatment
ECOG Performance Status 0-2
Participants must have normal organ and marrow function as defined below: - Absolute neutrophil count ≥ 1.5 x 10⁹/L - Platelet count ≥ 75 x 10⁹/L - Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) - AST/ALT ≤ 5 x ULN - Serum creatinine ≤ 1.5 x ULN or CrCl ≥ 50 mL/min (using the Cockcroft-Gault formula)
Women of childbearing potential (WOCBP) must use method(s) of contraception as indicated in the protocol
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year

Exclusion criteria 3

Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
Allergies and Adverse Drug Reaction - History of allergy to study drug components - Hypersensitivity to the active substances
WOCBP who are pregnant or breastfeeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Progression-free survival

Secondary endpoints 6

Overall Survival (OS) and OS rate at 6 and 12 months
Objective Response Rate and Disease Control Rate
Duration of Response
Progression-free survival on subsequent treatment (PFS 2)
Adverse events with causal relationship to study treatment
Adjusted mean change from baseline in global health status/QoL score, and functional and symptom scales from the EORTC QLQ-C30 questionnaire.

Investigational products

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

Test 26

Selpercatinib

SUB193120 · Substance

Active substance: Selpercatinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 320 mg milligram(s)
Max total dose: 350400 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Selpercatinib

SUB193120 · Substance

Active substance: Selpercatinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 320 mg milligram(s)
Max total dose: 350400 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Larotrectinib

SUB188650 · Substance

Active substance: Larotrectinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 200 mg milligram(s)
Max total dose: 219000 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Larotrectinib

SUB188650 · Substance

Active substance: Larotrectinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 200 mg milligram(s)
Max total dose: 219000 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Erlotinib

SUB16423MIG · Substance

Active substance: Erlotinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 150 mg milligram(s)
Max total dose: 164250 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Erlotinib

SUB16423MIG · Substance

Active substance: Erlotinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 150 mg milligram(s)
Max total dose: 164250 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Erlotinib

SUB16423MIG · Substance

Active substance: Erlotinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 150 mg milligram(s)
Max total dose: 164250 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Crizotinib

SUB32267 · Substance

Active substance: Crizotinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 500 mg milligram(s)
Max total dose: 547500 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Crizotinib

SUB32267 · Substance

Active substance: Crizotinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 500 mg milligram(s)
Max total dose: 547500 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Axitinib

SUB25427 · Substance

Active substance: Axitinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 21900 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Axitinib

SUB25427 · Substance

Active substance: Axitinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 21900 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Axitinib

SUB25427 · Substance

Active substance: Axitinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 21900 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Axitinib

SUB25427 · Substance

Active substance: Axitinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 21900 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pembrolizumab

SUB167136 · Substance

Active substance: Pembrolizumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 200 mg milligram(s)
Max total dose: 6800 mg milligram(s)
Max treatment duration: 102 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Olaparib

SUB32234 · Substance

Active substance: Olaparib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 600 mg milligram(s)
Max total dose: 657000 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Olaparib

SUB32234 · Substance

Active substance: Olaparib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 600 mg milligram(s)
Max total dose: 657000 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dabrafenib

SUB45696 · Substance

Active substance: Dabrafenib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 300 mg milligram(s)
Max total dose: 328500 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dabrafenib

SUB45696 · Substance

Active substance: Dabrafenib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 300 mg milligram(s)
Max total dose: 328500 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pemigatinib

SUB194579 · Substance

Active substance: Pemigatinib
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 13.5 mg milligram(s)
Max total dose: 9828 mg milligram(s)
Max treatment duration: 156 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pemigatinib

SUB194579 · Substance

Active substance: Pemigatinib
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 13.5 mg milligram(s)
Max total dose: 9828 mg milligram(s)
Max treatment duration: 156 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pemigatinib

SUB194579 · Substance

Active substance: Pemigatinib
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 13.5 mg milligram(s)
Max total dose: 9828 mg milligram(s)
Max treatment duration: 156 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Trametinib

SUB119776 · Substance

Active substance: Trametinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 2 mg milligram(s)
Max total dose: 2190 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Trametinib

SUB119776 · Substance

Active substance: Trametinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 2 mg milligram(s)
Max total dose: 2190 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Vismodegib

SUB32354 · Substance

Active substance: Vismodegib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 150 mg milligram(s)
Max total dose: 164250 mg milligram(s)
Max treatment duration: 1095 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Phesgo 600 mg/600 mg solution for injection

PRD8601831 · Product

Active substance: Trastuzumab
Substance synonyms: PF-05280014, TX05, BP02, ABP-980, SYD-977
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 1 DF dosage form
Max total dose: 51 DF dosage form
Max treatment duration: 156 Week(s)
Authorisation status: Authorised
ATC code: L01FY01 — -
Marketing authorisation: EU/1/20/1497/002
MA holder: ROCHE REGISTRATION GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Phesgo 1200 mg/600 mg solution for injection

PRD8600161 · Product

Active substance: Trastuzumab
Substance synonyms: PF-05280014, TX05, BP02, ABP-980, SYD-977
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 1 DF dosage form
Max total dose: 1 DF dosage form
Max treatment duration: 3 Week(s)
Authorisation status: Authorised
ATC code: L01FY01 — -
Marketing authorisation: EU/1/20/1497/001
MA holder: ROCHE REGISTRATION GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Comparator 8

Oxaliplatin

SUB09490MIG · Substance

Active substance: Oxaliplatin
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 130 mg/m2 milligram(s)/square meter
Max total dose: 6760 mg/m2 milligram(s)/square meter
Max treatment duration: 156 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Calcium Folinate

SUB06052MIG · Substance

Active substance: Calcium Folinate
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 400 mg/m2 milligram(s)/square meter
Max total dose: 31200 mg/m2 milligram(s)/square meter
Max treatment duration: 156 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Gemcitabine

SUB07892MIG · Substance

Active substance: Gemcitabine
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 1000 mg/m2 milligram(s)/square meter
Max total dose: 117000 mg/m2 milligram(s)/square meter
Max treatment duration: 156 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Irinotecan

SUB08295MIG · Substance

Active substance: Irinotecan
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 200 mg/m2 milligram(s)/square meter
Max total dose: 11700 mg/m2 milligram(s)/square meter
Max treatment duration: 156 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine

SUB12474MIG · Substance

Active substance: Capecitabine
Pharmaceutical form: FILM COATED TABLET
Route of administration: ORAL
Max daily dose: 1650 mg/m2 milligram(s)/square meter
Max total dose: 1351350 mg/m2 milligram(s)/square meter
Max treatment duration: 156 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Capecitabine

SUB12474MIG · Substance

Active substance: Capecitabine
Pharmaceutical form: FILM COATED TABLET
Route of administration: ORAL
Max daily dose: 1650 mg/m2 milligram(s)/square meter
Max total dose: 1351350 mg/m2 milligram(s)/square meter
Max treatment duration: 156 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Paclitaxel Albumin-Bound

SUB127678 · Substance

Active substance: Paclitaxel Albumin-Bound
Pharmaceutical form: POWDER FOR DISPERSION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 125 mg/m2 milligram(s)/square meter
Max total dose: 14625 mg/m2 milligram(s)/square meter
Max treatment duration: 156 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Fluorouracil

SUB07721MIG · Substance

Active substance: Fluorouracil
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS INFUSION
Max daily dose: 2400 mg/m2 milligram(s)/square meter
Max total dose: 187200 mg/m2 milligram(s)/square meter
Max treatment duration: 156 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Hovedstaden

Sponsor organisation: Region Hovedstaden
Address: Borgmester Ib Juuls Vej 1
City: Herlev
Postcode: 2730
Country: Denmark

Scientific contact point

Organisation: Region Hovedstaden
Contact name: Sponsor Investigator

Public contact point

Organisation: Region Hovedstaden
Contact name: Sponsor Investigator

Third parties 1

Organisation	City, country	Duties
Region Hovedstaden ORG-100003705	Frederiksberg, Denmark	On site monitoring

Locations

1 EU/EEA country · 4 investigational sites

By country

Country	MS status	Planned subjects	Sites
Denmark	Authorised, recruitment pending	1,200	4
Rest of world	—	0	—

Investigational sites

Denmark

4 sites · Authorised, recruitment pending

Region Hovedstaden

Department of Oncology, Borgmester Ib Juuls Vej 1, 2730, Herlev

Sygehus Lillebaelt Vejle Sygehus

Department of Oncology, Beriderbakken 4, 7100, Vejle

Aalborg University Hospital

Department of Oncology, Hobrovej 18-22, 9000, Aalborg

Region Midtjylland

Department of Oncology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Results and documents

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

Documents 38 files

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

Type	Title	Version
Protocol (for publication)	D1_Protocol _2025-522431-34-00_redacted	2.0
Protocol (for publication)	D4_Patient facing documents_EORTC QLQ-C30 _DK	3.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements	2
Subject information and informed consent form (for publication)	L1_ICF_tillaeg_retten ikke at vide	1.0
Subject information and informed consent form (for publication)	L1_SIS_bilag_Axitinib	1.0
Subject information and informed consent form (for publication)	L1_SIS_bilag_Crizotinib	1.0
Subject information and informed consent form (for publication)	L1_SIS_bilag_Dabrefenib_Trametinib	1.0
Subject information and informed consent form (for publication)	L1_SIS_bilag_Erlotinib	1.0
Subject information and informed consent form (for publication)	L1_SIS_bilag_Larotrectinib	1.0
Subject information and informed consent form (for publication)	L1_SIS_bilag_Olaparib	1.0
Subject information and informed consent form (for publication)	L1_SIS_bilag_Pembrolizumab	1.0
Subject information and informed consent form (for publication)	L1_SIS_bilag_Pemigatinib	1.0
Subject information and informed consent form (for publication)	L1_SIS_bilag_Phesgo	1.0
Subject information and informed consent form (for publication)	L1_SIS_bilag_Rettigheder som forsgsperson	1
Subject information and informed consent form (for publication)	L1_SIS_bilag_Selpercatinib	1.0
Subject information and informed consent form (for publication)	L1_SIS_bilag_Vismodegib	1.0
Subject information and informed consent form (for publication)	L1_SIS_ICF_Main	2.0
Subject information and informed consent form (for publication)	L2_Participant Card	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Axitinib	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Calciumfolinat	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Capecitabine	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Crizotinib	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Dabrafenib	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Erlotinib	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Fluorouracil	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Gemcitabine	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Irinotecan	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Larotectinib	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC nab_paclitaxel	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Oxaliplatin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Trametinib	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Olaparib	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Pembrolizumab	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Pemigatinib	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Phesgo	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Selpercatinib	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Vismodegib	NA
Synopsis of the protocol (for publication)	D1_Protocol synopsis_DK_2025-522431-34-00	1

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2026-03-04	Denmark	Acceptable 2026-05-18	2026-05-18

Molecularly Tailored Therapy versus Standard Care in Advanced Pancreatic Cancer

Overview

Key facts

Trial design

Main objective

Secondary objectives 3

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 9

Exclusion criteria 3

Endpoints

Primary endpoints 1

Secondary endpoints 6

Investigational products

Test 26

Comparator 8

Sponsors and contacts

Region Hovedstaden

Scientific contact point

Public contact point

Third parties 1

Locations

By country

Investigational sites

Results and documents

Documents 38 files

Application history

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