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A Phase 1 Study Of The Safety And Pharmacokinetics Of Oral PD-0332991, A Cyclin-Dependent Kinase 4 And 6 (CDK4/6) Inhibitor, In Japanese Patients With Advanced Solid Tumors


Phase 1
20 Years
N/A
Open (Enrolling)
Both
Neoplasms, Breast Neoplasms

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Trial Information

A Phase 1 Study Of The Safety And Pharmacokinetics Of Oral PD-0332991, A Cyclin-Dependent Kinase 4 And 6 (CDK4/6) Inhibitor, In Japanese Patients With Advanced Solid Tumors


Inclusion Criteria:



- In Part 1, advanced solid tumor (except SCLC or retinoblastoma) proven histologically
or cytologically at original diagnosis, that is refractory to standard therapy or for
whom no standard of care therapy is available.

- In Part 2, post menopausal women with proven diagnosis of ER-positive, HER2-negative
adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic
disease (including bone only disease) not amenable to resection or radiation therapy
with curative intent and for whom chemotherapy is not clinically indicated.

- Adequate blood cell counts, kidney function and liver function and and Eastern
Cooperative Oncology Group [ECOG] score of 0 or 1.

- Resolved acute effects of any prior therapy to baseline severity or Grade ≤1

Exclusion Criteria:

- Active uncontrolled or symptomatic CNS metastases.

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

First cycle Dose Limiting Toxicities

Outcome Time Frame:

28 days after first dose

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

A5481010

NCT ID:

NCT01684215

Start Date:

October 2012

Completion Date:

September 2015

Related Keywords:

  • Neoplasms
  • Breast Neoplasms
  • Phase 1 study
  • PD-0332991
  • Cyclin Dependant Kinase 4/6 inhibitor
  • Japanese
  • solid tumors
  • breast cancer
  • Breast Neoplasms
  • Neoplasms

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