Status:
COMPLETED
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.
Lead Sponsor:
Pfizer
Conditions:
Lymphoma, Mantle-Cell
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
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 c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00420056
Start Date
May 1 2007
End Date
March 1 2012
Last Update
October 28 2015
Active Locations (6)
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1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
4
New York Presbyterian Hospital
New York, New York, United States, 10021