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A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer

Last updated on February 20, 2019

FOR MORE INFORMATION
Study Location
Aichi Cancer Center Hospital
Nagoya, Aichi, 464-8681 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms, Breast Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Phase 1

- 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 and Phase 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

Phase 2

- Adult women (≥ 20 years of age) with proven diagnosis of adenocarcinoma of the breast
with evidence of locoregionally recurrent or metastatic disease not amenable to
resection or radiation therapy with curative intent and for whom chemotherapy is not
clinically indicated.

- Documentation of histologically or cytologically confirmed diagnosis of ER(+) breast
cancer based on local laboratory results.

- Adequate blood cell counts, kidney function and liver function and and Eastern
Cooperative Oncology Group [ECOG] score of 0 to 2.

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

Phase 1

- 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

Phase 2

- HER2 positive tumor based on local laboratory results utilizing one of the sponsor
approved assays.

- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or
leptomeningeal disease.

- Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie,
anastrozole or letrozole) with disease recurrence while on or within 12 months of
completing treatment.

NCT01684215
Pfizer
Completed
A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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