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:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT04935359
Eligibility Criteria:
Inclusion Criteria:
* Applicable for both Safety run-in and Randomized part
* Participants aged ≥18 years with histologically or cytologically confirmed (based on local assessment and per local guidelines) mPDAC eligible for treatment in the first line setting and not amenable for potentially curative surgery
* Presence of at least one measurable lesion assessed by Computerized Tomography (CT) and/or Magnetic Resonance Imaging (MRI) according to RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Adequate organ function (assessed by central laboratory for eligibility)
* Participants must have recovered from treatment-related toxicities of prior anticancer therapies to grade ≤ 1 (CTCAE v 5.0) at time of screening, except alopecia.
Main Exclusion Criteria:
* Applicable for both Safety run-in and Randomized part
* Previous systemic anti-cancer treatment for metastatic PDAC
* Pancreatic neuroendocrine (islet) or acinar tumors
* Participants with known status of microsatellite instability-high (MSI-H) or mismatch repair-deficient pancreatic cancer (if status is not already available, testing is not required at screening).
* Participant has not recovered from a major surgery performed prior to start of study treatment or has had a major surgery within 4 weeks prior to start of study treatment.
* Radiation therapy or brain radiotherapy ≤ 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed \> 2 weeks prior to start of study treatment).
* Impaired cardiac function or clinically significant cardio-vascular disease
* Use of hematopoietic growth factors or transfusion support ≤ 2 weeks prior to start of study treatment.
* Participant has conditions that are considered to have a high risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding.
* Serious non-healing wounds.
* Pregnant or breast-feeding women
* Women of childbearing potential, unless willing to use highly effective contraception methods during treatment and after stopping study treatments as indicated
* Pre-existing peripheral neuropathy \> grade 1 (CTCAE v5.0)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04935359
Study Brief:
Protocol Section:
NCT04935359