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 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT02501902
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically-confirmed metastatic pancreatic ductal adenocarcinoma.
* Availability of a tumor tissue specimen. If no archived tumor tissue is available, then a de novo biopsy is required for patient participation.
* Karnofsky Performance Status 70 or greater.
* Adequate Bone Marrow, Renal, and Liver Function.
Exclusion Criteria:
* Prior treatment with a CDK 4/6 inhibitor.
* Prior treatment with nab-P for the treatment of metastatic disease.
* Patients with known CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth.
* Diagnosis of any other malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
* QTc \>480 msec, or family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.
* Uncontrolled electrolyte disorders.
* Cardiac or pulmonary disorders within 6 months of enrollment.
* Known human immunodeficiency virus infection.
* History of interstitial lung disease or pneumonitis.
* Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nab-P.
* Difficulty swallowing capsules or requirement for a feeding tube.
* Previous high-dose chemotherapy requiring stem cell rescue.
* Pregnant female patients; breastfeeding female patients; male patients with partners currently pregnant.
* Active inflammatory or other gastrointestinal disease,
* Active bleeding disorder in the past 6 months.
* Patients treated within the last 7 days prior to the start of IP with strong/moderate CYP3A4 inhibitors, strong/moderate CYP3A4 inducers, CYP2C8 inhibitors, strong/moderate CYP2C8 inducers, or drugs that are known to prolong the QT interval.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02501902
Study Brief:
Protocol Section:
NCT02501902