An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.

Completed · Phase 1

Conditions studied: Lymphoma, Mantle-Cell

In brief

This is a pilot study evaluating tumor activity using Positron Emission Tomography, which is also known as a "PET scan". This study will assess the safety of using PD-0332991 in patients with mantle cell lymphoma.

Key facts

Study ID

NCT00420056

Run by

Pfizer

People needed

17

Starts

2007-05-01

Expected to finish

2012-03-01

Last updated by the study team

2015-10-28

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically documented MCL.
• Must have received at least one prior therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
• Adequate organ function as outlined in the protocol.

You may not qualify if…

• Major surgery, radiation therapy, or systemic therapy within 4 weeks of study enrollment.
• Prior radiation therapy to >25% of the bone marrow (whole pelvis is 25%).
• Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.

Where it is running

• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• New York Presbyterian Hospital — New York, New York, United States
• Weill Medical College of Cornell University - New York Presbyterian Hospital — New York, New York, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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