Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In mPDAC

• Status: Completed
• Trial end date: 2018-12-27
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, open label, multi center, multiple dose, dose escalation, safety, pharmacokinetic and pharmacodynamic study of palbociclib in combination with nab-P, in sequential cohorts of adult patients with mPDAC, with MTD expansion cohort(s). Approximately 30-60 patients are expected to be enrolled in the overall study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborator: Celgene
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel; Palbociclib

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.