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Palbociclib

Protein Kinase Inhibitors

Enzyme Inhibitors

This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.

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.

Palbociclib 200mg

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.

Palbociclib 125mg

Mark Dickson, MD

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.

PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma

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

PFS, defined as RECIST 1.1 (CR + PR + SD) when treated with Palbociclib

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Pfizer

Memorial Sloan Kettering Cancer Center

This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.

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.

This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.

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.

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Progression Free Survival at 12 Weeks

This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma	NCT01209598	Sarcoma Liposarcoma	Palbociclib 200... Palbociclib 125...	18 Years -	Memorial Sloan Kettering Cancer Center
PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma	NCT01209598	Sarcoma Liposarcoma	Palbociclib 200... Palbociclib 125...	18 Years -	Memorial Sloan Kettering Cancer Center

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