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A Pilot Study Of PD-0332991 In Patients With Previously Treated Mantle Cell Lymphoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Mantle-Cell

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Trial Information

A Pilot Study Of PD-0332991 In Patients With Previously Treated Mantle Cell Lymphoma


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the use of PET as an assessment of target modulation.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A5481002

NCT ID:

NCT00420056

Start Date:

May 2007

Completion Date:

March 2012

Related Keywords:

  • Lymphoma, Mantle-cell
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site North Adams, Massachusetts  01247
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535