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.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Lymphoma, Mantle-Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PD-0332991

Group Type EXPERIMENTAL

PD-0332991

Intervention Type DRUG

125 mg, oral, Days 1-21 of a 28-day cycle

Interventions

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PD-0332991

125 mg, oral, Days 1-21 of a 28-day cycle

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No