Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In mPDAC (NCT02501902) | Clinical Trial Compass
CompletedPhase 1
Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In mPDAC
United States76 participantsStarted 2015-11-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 tu…
What they're measuring
1
Number of Participants With Dose Limiting Toxicities
Timeframe: From Day 1 until pre-dose Cycle 2 Day 1