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.

Pfizer

Status and phase: Completed; Phase 1

Conditions: Lymphoma, Mantle-Cell

Treatments: Drug: PD-0332991

Study type: Interventional

Funder types: Industry

Identifiers

NCT00420056

A5481002

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

PD-0332991

Experimental group

Treatment:

Drug: PD-0332991