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

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.

Timeline

Start

2015-11-23

Primary completion

2018-10-10

Completion

2018-12-27

Publications

• Hidalgo M, Garcia-Carbonero R, Lim KH, Messersmith WA, Garrido-Laguna I, Borazanci E, Lowy AM, Medina Rodriguez L, Laheru D, Salvador-Barbero B, Malumbres M, Shields DJ, Grossman JE, Huang X, Tammaro M, Martini JF, Yu Y, Kern K, Macarulla T. A Preclinical and Phase Ib Study of Palbociclib plus Nab-Paclitaxel in Patients with Metastatic Adenocarcinoma of the Pancreas. Cancer Res Commun. 2022 Nov 2;2(11):1326-1333. doi: 10.1158/2767-9764.CRC-22-0072. eCollection 2022 Nov.

Drugs

Indications