NCT03194373

Phase II Trial Evaluating the Efficacy of Palbociclib in Combination With Carboplatin for the Treatment of Unresectable Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

A Multi-Center Open Label Single Arm Phase II Trial Evaluating the Efficacy of Palbociclib in Combination With Carboplatin for the Treatment of Unresectable Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug combination of palbociclib (Ibrance) plus carboplatin in patients with metastatic head and neck squamous cell cancer.

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DRUG	Palbociclib	Palbociclib (Ibrance) (PO), dose= 125 mg PO daily, days=1-14, cycle length: 21 days Maintenance Palbociclib: Palbociclib (Ibrance) 125 mg PO daily, days 1-21, cycle length: 28 days
DRUG	Carboplatin	Carboplatin (IV), dose= AUC 5, day= 1, cycle length: 21 days

Timeline

• Start date: 2017-10-12
• Primary completion: 2019-02-01
• Completion: 2020-03-17
• First posted: 2017-06-21
• Last updated: 2021-04-12
• Results posted: 2020-02-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study