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A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors

Last updated on April 11, 2019

FOR MORE INFORMATION
Study Location
Aichi Cancer Center Hospital
Nagoya, Aichi, 464-0021 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

- Histological or cytological diagnosis of locally advanced or metastatic solid tumor
that is resistant to standard therapy or for which no standard therapy is available.

- ECOG Performance Status 0 or 1.

- Adequate Bone Marrow, Renal and Liver Function.

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

- Patients with known symptomatic brain metastases requiring steroids.

- Current use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of
BCRP within 1 week or 5 half lives which ever is longer prior to the first dose of
study treatment.

- Fertile male patients and female patients of childbearing potential who are unwilling
or unable to use 2 highly effective methods of contraception.

[Dose Expansion Part]

Inclusion Criteria:

- Histologically or cytologically confirmed carcinoma of the breast.

- Locally advanced breast cancer that is not amenable to curative radiation or surgery
and/or metastatic disease.

- Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or
BRCA2 mutation by Myriad Genetics' BRACAnalysis CDx test.

- No more than 3 prior chemotherapy-inclusive regimens for locally advanced or
metastatic disease.

- Have measurable lesion by the RECIST v.1.1.

- ECOG Performance Status 0-2.

- Adequate Bone Marrow, Renal and Liver Function.

Exclusion Criteria:

- First-line locally advanced or metastatic breast cancer with no prior neoadjuvant and
adjuvant chemotherapy.

- Prior treatment with a PARP inhibitor.

- Objective disease progression while receiving platinum chemotherapy administered for
locally advanced or metastatic disease.

- HER2 positive breast cancer.

- Active inflammatory breast cancer.

- Central nervous system (CNS) metastases.

- Current or anticipated use within 7 days prior to the first dose of study treatment,
or anticipated use during the study of strong P-gp inhibitors.

- Fertile male patients and female patients of childbearing potential who are unwilling
or unable to use 2 highly effective methods of contraception.

NCT03343054
Pfizer
Recruiting
A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors

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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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FOR MORE INFORMATION

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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