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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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00420056
First received: January 5, 2007
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Lymphoma, Mantle-Cell
Drug: PD-0332991
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Of PD-0332991 In Patients With Previously Treated Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To evaluate the use of PET as an assessment of target modulation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To assess the overall safety profile characterized by type, incidence, severity, timing, seriousness, and relationship to study therapy of adverse events and any laboratory abnormalities. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Explore potential PD-0332991 concentration-effect relationships. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Evaluate efficacy with diseases assessments: Progression Free Survival (PFS), Overall Response Rate (ORR), Duration of Response (DR), and time to Tumor Progression (TTP) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: May 2007
Study Completion Date: March 2012
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PD-0332991 Drug: PD-0332991
125 mg, oral, Days 1-21 of a 28-day cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420056

Locations
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00420056     History of Changes
Other Study ID Numbers: A5481002
Study First Received: January 5, 2007
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014