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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.

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NCT00420056

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Brigham & Women's Hospital
Boston, Massachusetts, 02115 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Mantle-Cell Lymphoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00420056
Pfizer
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.

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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.
A Pilot Study Of Pd 0332991 In Patients With Previously Treated Mantle Cell Lymphoma
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma, Mantle-Cell
Drug: PD-0332991
125 mg, oral, Days 1-21 of a 28-day cycle
Experimental: PD-0332991
Intervention: Drug: PD-0332991
Leonard JP, LaCasce AS, Smith MR, Noy A, Chirieac LR, Rodig SJ, Yu JQ, Vallabhajosula S, Schoder H, English P, Neuberg DS, Martin P, Millenson MM, Ely SA, Courtney R, Shaik N, Wilner KD, Randolph S, Van den Abbeele AD, Chen-Kiang SY, Yap JT, Shapiro GI. Selective CDK4/6 inhibition with tumor responses by PD0332991 in patients with mantle cell lymphoma. Blood. 2012 May 17;119(20):4597-607. doi: 10.1182/blood-2011-10-388298. Epub 2012 Mar 1.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
March 2012
March 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00420056
A5481002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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