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.

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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 cell lymphoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Palbociclib

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.