Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT03943667
Eligibility Criteria:
Inclusion Criteria:
* Metastatic Pancreatic Ductal Adenocarcinoma with histological or cytological proof
* Age ≥18 years
* At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 outside any previously irradiated area
* Failure of first line FOLFIRINOX (Progressive disease during therapy of within 3 months +/- 15 days)
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
* Life expectancy ≥12 weeks
* Negative serology (HIV, hepatitis B and C)
* Adequate organs function
* Proven Post-menopausal status or negative urinary or serum pregnancy test
* Woman of childbearing potential and male patients must agree to use adequate contraception fo the duration of the trial and up to 6 months after completing treatment
* Patients affiliated to the social security system
* Patient must have signed a written informed consent form
Exclusion Criteria:
* Any other primary tumor or secondary malignancy except basal cell carcinoma of skin or in situ carcinoma of the cervix uteri
* Known cerebral metastasis
* Uncontrolled severe infections
* Patients with Kaposi's sarcoma
* Peripheral neuropathy exceeding grade 2 on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
* Previous treatment with taxane and/or gemcitabine (for pancreas cancer only)
* Patients with known allergy or severe hypersensitivity to any trial drug or drug excipient
* Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment
* Patients unable to comply with trial obligations for geographic, social or physical reasons, or who are unable to understand the purpose and procedures of the trial
* Participation in another clinical trial within 14 days prior to randomization
* Patients deprived of liberty or under legal protection measures or patients whose willingness to participate in the trial may be unduly influenced
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03943667
Study Brief:
Protocol Section:
NCT03943667