NCT01209598

PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma

A Phase II Study Of PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out what effects, good and/or bad, Palbociclib (Ibrance) (formerly known as PD0332991) has on the patient and on the liposarcoma. Palbociclib is an investigational drug. An investigational drug is a medication that has not been approved for marketing by the Food and Drug Administration (FDA). Palbociclib blocks a protein called CDK4 which is part of a pathway in liposarcoma cells that is over-active. The investigators hope that blocking CDK4 will shut down this pathway in the liposarcoma cells and stop tumors from growing. Palbociclib is an oral medication.

Conditions

• Sarcoma
• Liposarcoma

Interventions

Type	Name	Description
DRUG	Palbociclib 200mg	Schedule 2/1: Palbociclib 200mg given once daily by mouth for 14 consecutive days, followed by 7 days of rest. A cycle will be defined as 21 days.
DRUG	Palbociclib 125mg	Schedule 3/1: Palbociclib 125mg given once daily by mouth for 21 consecutive days, followed by 7 days of rest. A cycle will be defined as 28 days. Following the positive results of the study, a new Expansion Cohort has been added to permit enrollment of up to 20 additional patients. Expansion Cohort: Dosed as per Schedule 3/1. Capsules should be taken with food.

Timeline

• Start date: 2010-09-23
• Primary completion: 2016-10-25
• Completion: 2016-10-25
• First posted: 2010-09-27
• Last updated: 2017-11-06
• Results posted: 2017-11-06

Locations

1 site across 1 country: United States