Informations générales (source: ClinicalTrials.gov)
Pilot Study of Personalized First-line Chemotherapy Choice for Patients With Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures (PACsign) (PACsign)
Interventional
N/A
Institut Curie (Voir sur ClinicalTrials)
décembre 2022
décembre 2026
29 juin 2024
The aim of this study is to assess the clinical value of 5 transcriptomic signatures
prognostic of chemotherapeutic sensitivity to improve the Objective Response Rate (ORR)
of first-line (L1). Chemotherapy regimen (FOLFIRINOX vs Gem-nabP) will be selected based
on transcriptomic signatures applied to the pre-therapeutic liver biopsy of newly
diagnosed PDAC patients.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/09/2024 13:49:28 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Beaujon | Louis DE MESTIER, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Charlotte FENIOUX, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital Claude Hurriez - 59037 - Lille - France | Antony TURPIN, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - 13573 - Marseille - France | Brice CHANEZ, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Written informed consent obtained from the patient prior to performing any
protocol-related procedures, including screening evaluations.
2. Willing and able to comply with the protocol for the duration of the study including
undergoing treatment and scheduled visits and examinations including follow up.
3. Histologically or cytologically proven Pancreatic Ductal Adenocarcinoma (PDAC).
4. Metastatic disease.
5. Measurable or evaluable lesions according to RECIST v1.1 criteria.
6. First-line therapy (previous neoadjuvant/adjuvant chemotherapy not allowed).
7. Age ≥ 18 years (no upper limit, patients ≥ 75 years old must have a G8 score ≥ 14).
8.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
9. Availability of tumor tissue sample from the primary pancreatic tumor or liver
metastasis (chemo-naïve) before inclusion in step 1.
10. Adequate organ function, as defined by the following (blood test ≤ 7 days prior to
inclusion):
1. Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT)
≤ 3 x upper limit of normal (ULN) (≤ 5 ULN in case of liver metastases)
2. Total serum bilirubin ≤ 1.5 ULN
3. Serum albumin ≥ 28 g/L
4. Hemoglobin ≥ 9.0 g/dl
5. Absolute neutrophil count (ANC) ≥ 1,500/μL
6. Platelets ≥ 100,000/μL
7. Creatinine clearance ≥ 50 mL/min (MDRD).
11. No Dihydropyrimidine dehydrogenase (DPD) deficiency (normal uracil level).
12. Life expectancy ≥ 3 months.
13. a. Evidence of post-menopausal status b. (or) negative urinary or serum pregnancy
test for female pre-menopausal patients.
14. Registration in a National Health Care System.
1. Written informed consent obtained from the patient prior to performing any
protocol-related procedures, including screening evaluations.
2. Willing and able to comply with the protocol for the duration of the study including
undergoing treatment and scheduled visits and examinations including follow up.
3. Histologically or cytologically proven Pancreatic Ductal Adenocarcinoma (PDAC).
4. Metastatic disease.
5. Measurable or evaluable lesions according to RECIST v1.1 criteria.
6. First-line therapy (previous neoadjuvant/adjuvant chemotherapy not allowed).
7. Age ≥ 18 years (no upper limit, patients ≥ 75 years old must have a G8 score ≥ 14).
8.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
9. Availability of tumor tissue sample from the primary pancreatic tumor or liver
metastasis (chemo-naïve) before inclusion in step 1.
10. Adequate organ function, as defined by the following (blood test ≤ 7 days prior to
inclusion):
1. Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT)
≤ 3 x upper limit of normal (ULN) (≤ 5 ULN in case of liver metastases)
2. Total serum bilirubin ≤ 1.5 ULN
3. Serum albumin ≥ 28 g/L
4. Hemoglobin ≥ 9.0 g/dl
5. Absolute neutrophil count (ANC) ≥ 1,500/μL
6. Platelets ≥ 100,000/μL
7. Creatinine clearance ≥ 50 mL/min (MDRD).
11. No Dihydropyrimidine dehydrogenase (DPD) deficiency (normal uracil level).
12. Life expectancy ≥ 3 months.
13. a. Evidence of post-menopausal status b. (or) negative urinary or serum pregnancy
test for female pre-menopausal patients.
14. Registration in a National Health Care System.
1. Concurrent enrolment in another interventional clinical study.
2. Previous treatment with chemotherapy for pancreatic cancer.
3. Uncontrolled massive pleural effusion or massive ascites.
4. Known deficiency in UGT1A1 (homozygous UGT1A1*28 allele).
5. Active bacterial, viral, or fungal infection requiring systemic therapy, including
tuberculosis, hepatitis B (known positive Hepatitis B Virus surface antigen (HBsAg)
result), hepatitis C (with positive RNA), Sars-Cov-2 or human immunodeficiency virus
(positive HIV 1/2 antibodies).
6. Diagnosis of any second malignancy within the last 3 years, except for adequately
treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix
uteri.
7. Known active central nervous system metastases and/or carcinomatous meningitis;
patients with previously treated brain metastases may participate provided they are
stable (without evidence of progression by imaging for at least 4 weeks prior to the
first dose of trial treatment and any neurologic symptoms have returned to
baseline).
8. Uncontrolled intercurrent illness, including but not limited to, symptomatic
congestive heart failure or coronary disease, peripheral artery disease, severe
chronic obstructive pulmonary disease, decompensated cirrhosis, serious chronic
gastrointestinal conditions associated with diarrhea, or psychiatric illness/social
situations that would limit compliance with study requirement, substantially
increase risk of incurring AEs or compromise the ability of the patient to give
written informed consent.
9. Live vaccine administration within 30 days prior to the first dose of study
treatment.
10. Known or suspected allergy or hypersensitivity to any of the study drugs or any of
the study drug excipients.
11. History or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the trial, interfere with participation for the
full duration of the trial, or is not in the best interest of the participant, in
the opinion of the treating investigator.
12. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of
radiation within 4 weeks of the first dose of study drug.
13. Major surgical procedure (as defined by the Investigator) within 4 weeks prior to
the first dose of trial treatment.
14. Pregnancy/lactation.
15. Person under legal protection or tutelage or guardianship.