Clinical trial • Phase III • Oncology|Cardiology

Clopidogrel for Pancreatic ductal adenocarcinoma|Pancreatic ductal cancer

Phase III trial of Clopidogrel for Pancreatic ductal adenocarcinoma|Pancreatic ductal cancer.

Overview

Trial Therapeutic Area
Oncology|Cardiology
Trial Disease
Pancreatic ductal adenocarcinoma|Pancreatic ductal cancer
Trial Stage
Phase III
Drug Modality
Small molecule|Other

Key dates

Initial CTIS Submission Date
06-05-2024
First CTIS Authorization Date
26-08-2024

Trial design

Randomised, open-label, control: standard-of-care thromboprophylaxis (treating physician selects between 'on demand thromboprophylaxis' or 'always thromboprophylaxis' as standard-of-care prior to randomization). thromboprophylaxis will be given as dalteparin 5000 iu once daily. intervention: standard-of-care thromboprophylaxis + clopidogrel 75 mg once daily. Phase III trial across 5 sites in Norway.

Randomised
Yes
Open Label
Yes
Comparator
Control: standard-of-care thromboprophylaxis (treating physician selects between 'on demand thromboprophylaxis' or 'always thromboprophylaxis' as standard-of-care prior to randomization). Thromboprophylaxis will be given as dalteparin 5000 IU once daily. Intervention: standard-of-care thromboprophylaxis + clopidogrel 75 mg once daily.
Target Sample Size
744

Eligibility

Recruits 744 No vulnerable populations selected (isVulnerablePopulationSelected = false). Informed consent and subject information documents are provided (L1_SIS and ICF pancreatic cancer group; L1_SIS and ICF healthy control group; L1_SIS and ICF Biobank). Assent procedures are not described..

Pregnancy Exclusion
Known pregnancy (pregnancy test is not necessary)
Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected = false). Informed consent and subject information documents are provided (L1_SIS and ICF pancreatic cancer group; L1_SIS and ICF healthy control group; L1_SIS and ICF Biobank). Assent procedures are not described.

Inclusion criteria

  • {"criterion_text":"- Participants are >18 years of age.\n- Patients with locally advanced, metastatic or recurrent (after intended therapeutic treatment) pancreatic ductal adenocarcinoma.\n- Patients where there is planned treatment or already receive treatment for their pancreatic ductal cancer.\n- Patients receiving neoadjuvant chemotherapy before intended curative surgery."}

Exclusion criteria

  • {"criterion_text":"- Current use of antiplatelet therapy or disease with indication for antiplatelet therapy not yet initiated.\n- Known hypersensitivity to clopidogrel or dalteparin\n- Known CYP2C19 genotype that influences clopidogrel metabolism (genotyping not necessary)\n- Current use of full dose anti-coagulation or disease with indication of full dose anti-coagulation. Patients already on primary prophylaxis can be included.\n- Platelets <30×10^9/L.\n- Severe intestinal malabsorption.\n- Known allergies to study medication.\n- Active bleeding or severe risk of bleeding.\n- Clinically significant liver disease (e.g., chronic active hepatitis, or cirrhosis).\n- Known previous heparin induced thrombocytopenia – HIT\n- Known pregnancy (pregnancy test is not necessary)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Efficacy: A composite of objectively verified arterial or venous thrombosis. Safety: Major bleeding.","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Death","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
744
Recruitment Window Months
120
Consent Approach
Informed consent is obtained from participants; subject information and informed consent forms are provided (L1_SIS and ICF pancreatic cancer group; L1_SIS and ICF healthy control group; Biobank ICF). Participants are adults (>18). No assent procedure described.

Geography

Total Number Of Sites
5
Total Number Of Participants
744

Norway

Earliest CTIS Part Ii Submission Date
30-07-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
652
Number Of Sites
5
Number Of Participants
744

Sites

Site Name
St. Olavs Hospital HF
Department Name
Department of oncology
Principal Investigator Name
Jens Erik Slagsvold
Principal Investigator Email
jens.erik.slagsvold@stolavs.no
Contact Person Name
Jens Erik Slagsvold
Contact Person Email
jens.erik.slagsvold@stolavs.no
Site Name
Drammen Sykehus
Department Name
Department of Oncology
Principal Investigator Name
Alina Carmen Porojnicu
Principal Investigator Email
alinacp@vestre.viken.no
Contact Person Name
Alina Carmen Porojnicu
Contact Person Email
alinacp@vestre.viken.no
Site Name
Nordlandssykehuset HF
Department Name
Department of Cancer
Principal Investigator Name
Silje Elisabeth Pedersen Gunnestad
Contact Person Name
Silje Elisabeth Pedersen Gunnestad
Site Name
Akershus University Hospital
Department Name
Department of hematology
Principal Investigator Name
Trine-Lise Larsen
Principal Investigator Email
trine.lise.larsen@ahus.no
Contact Person Name
Trine-Lise Larsen
Contact Person Email
trine.lise.larsen@ahus.no
Site Name
Sykehuset Oestfold HF Kalnes
Department Name
Oncology
Principal Investigator Name
Anette Kjær Syversen
Principal Investigator Email
anette.kjaer@so-hf-no
Contact Person Name
Anette Kjær Syversen
Contact Person Email
anette.kjaer@so-hf-no

Sponsor

Primary sponsor

Full Name
Akershus University Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Norway

Investigational products

Investigational Product Name
Plavix 75 mg film-coated tablets
Active Substance
Clopidogrel
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation present: EU/1/98/069/001)
Starting Dose
75 mg
Frequency
Once daily
Maximum Dose
75 mg
Investigational Product Name
Fragmin 5 000 IE injeksjonsvæske, oppløsning i ferdigfylt sprøyte
Active Substance
Dalteparin sodium
Modality
Other
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Authorised (marketing authorisation present: 23-15952, Norway)
Starting Dose
5000 IU
Frequency
Once daily
Maximum Dose
5000 IU
Combination Treatment
Yes

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