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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT03086369
Eligibility Criteria:
Inclusion Criteria:
* Histological or cytological diagnosis of adenocarcinoma of the exocrine pancreas that is metastatic (Stage IV) and not amenable to resection with curative intent.
* If present, clinically significant or symptomatic amounts of ascites should be drained prior to Day 1.
* Have had no prior systemic treatment for metastatic disease. Prior adjuvant or neo-adjuvant chemotherapy or radiochemotherapy (other than nab-paclitaxel) is allowed if completed ≥3 months prior to enrollment and no lingering toxicities are present.
* Prior radiation therapy for treatment of cancer is allowed to \<25% of the bone marrow.
* Phase 2: archival tumor tissue or be willing to provide a pre-treatment biopsy.
* Measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Discontinued all previous treatments for cancer ≥4 weeks prior.
* Adequate organ function.
* Life expectancy of at least 3 months.
Exclusion Criteria:
* Serious concomitant systemic disorder.
* Have received first line treatment for metastatic pancreatic cancer.
* Received prior treatment with nab-paclitaxel.
* Have known central nervous system malignancy or metastasis.
* Current hematologic malignancies.
* Participated within the last 30 days in a clinical trial involving an investigational product.
* Women with a positive pregnancy test or lactating.
* Have endocrine pancreatic tumors or ampullary cancer.
* Currently enrolled in another clinical trial.
* Have a known additional malignancy that is progressing or required active treatment within the past 1 year.
* Known allergy to nab-paclitaxel or gemcitabine or any ingredient of study drug formulations.
* Are taking certain anti-coagulant medications such as warfarin and are unable to be switched to other similar medicines.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03086369
Study Brief:
Protocol Section:
NCT03086369