- 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.
- 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
- 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
- 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.