Phase 1 Trial of Palbociclib With Chemotherapy for Solid Tumors
Safety, tolerability, and efficacy of palbociclib in combination with cisplatin or carboplatin among patients with advanced/metastatic solid tumors.
Title: A Phase 1 Study of Palbociclib in Combination With Cisplatin or Carboplatin in Advanced Solid Malignancies1
Principal Investigator(s): Taofeek Owonikoko, MD, PhD, Emory University
Description: For this phase 1, open label, non-randomized study (ClinicalTrials.gov Identifier: NCT02897375), researchers are attempting to determine the safety, tolerability, and efficacy of palbociclib in combination with cisplatin or carboplatin among patients with advanced/metastatic solid tumors.
Patients with head and neck cancer, pancreatic cancer, breast cancer, lung cancer, sarcoma, ovarian cancer, colorectal cancer, and bladder cancer are eligible, though this list is not exhaustive.
The study has 2 arms: in Arm A, patients will receive palbociclib with cisplatin; in Arm B, patients will receive palbociclib with carboplatin.
The primary objectives are safety and tolerability of the 2 combinations and establishment of a recommended phase 2 dose.
Secondary outcomes include anti-tumor efficacy of the combinations as well as pharmacokinetic profiles of cisplatin and carboplatin.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02897375.
Status: This study is open and recruiting patients as of May 1, 2017.
This study is sponsored by Emory University in collaboration with Pfizer.
- Clinicaltrials.gov. Palbociclib with cisplatin or carboplatin in advanced solid tumors. NCT02897375. https://clinicaltrials.gov/ct2/show/NCT02897375. Accessed May 1, 2017.