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A Study Of Oral Palbociclib (PD-0332991), A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Neoplasms
Lymphoma, Non-Hodgkin

Treatments

Drug: PD-0332991

Study type

Interventional

Funder types

Industry

Identifiers

NCT00141297
A5481001

Details and patient eligibility

About

PD-0332991 may work in cancer by stopping cancer cells from multiplying. PD-0332991 is in a new class of drugs called cyclin-dependent kinase (CDK inhibitors). This research study is the first time that PD-0332991 will be given to people. PD-0332991 is taken by mouth daily.

Enrollment

74 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Advanced solid tumors (excluding SCLC and retinoblastoma) or follicular of diffuse large cell non-Hodgkin's lymphoma, histologically or cytologically proven at diagnosis which is refractory to or intolerant of established therapy know to provide clinical benefit for their condition; tumors must express Rb
  • Adequate blood cell counts, kidney function and liver function and and ECOG score of 0, 1, or 2.
  • Patients may have to have tumor biopsy before and after treatment.

Exclusion criteria

  • Prior stem cell or bone marrow transplant
  • Uncontrolled infection, unstable or sever intercurrent medical condition, or current drug or alcohol abuse
  • Active or unstable cardiac disease or history of heart attack within 6 months

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

74 participants in 1 patient group

PD-0332991
Experimental group
Treatment:
Drug: PD-0332991

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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