A Pilot Study Of PD-0332991 In Patients With Previously Treated Mantle Cell Lymphoma
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Lymphoma, Mantle-Cell
Both
Lymphoma, Mantle-Cell
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 |
