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

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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.

- Able to take oral medications.

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

- Serum or urine pregnancy test (for females of childbearing potential) negative at
screening.

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.

- Major surgery within 4 weeks prior to the first dose of study treatment.

- Radiation therapy within 4 weeks prior to the first dose of study treatment.

- Any antitumor systemic cytotoxic therapies and/or treatment with immune modulators
within 4 weeks prior to the first dose of study treatment.

- Previous high dose chemotherapy requiring stem cell rescue.

- Prior irradiation to >25% of the bone marrow.

- Active and clinically significant bacterial, fungal, or viral infection

- Myocardial infarction within 6 months before starting therapy, symptomatic congestive
heart failure, unstable angina, or unstable cardiac arrhythmia requiring medication.

- Hypertension that cannot be controlled by medications.

- Participation in other studies involving investigational drug(s) within 4 weeks prior
to the first dose of study treatment.

- Other acute or chronic medical or psychiatric condition, or laboratory abnormality
that may increase the risk associated with study participation or investigational
product administration or may interfere with the interpretation of study results and
would make the patient inappropriate for entry into this study.

- Fertile male patients and female patients of childbearing potential who are unwilling
or unable to use 2 highly effective methods of contraception and for 180 days after
the last dose of investigational product.

- Breastfeeding at screening or at any time during study participation.

- 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.

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

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A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors
A Phase 1 Study Of The Safety, Pharmacokinetics And Anti-tumor Activity Of Talazoparib, Poly (Adp-ribose) Polymerase (Parp) Inhibitor, In Japanese Patients With Advanced Solid Tumors

This is a Phase 1, open label, dose escalation, safety, preliminary efficacy and pharmacokinetic (PK) study of single agent talazoparib in sequential cohorts of adult patients with advanced solid tumors who are resistant to standard therapy or for whom no standard therapy is available. Successive cohorts of patients will receive escalating doses of talazoparib on an outpatient starting from 0.75 mg/day. This study will evaluate 2 dose levels; 0.75 mg and 1.0 mg. Treatment with investigational product will continue until either disease progression, patient refusal, or unacceptable toxicity occurs. The proposed doses, schedule(s), and PK time points may be reconsidered and amended during the study based on the emerging safety and PK data.

In the study overall, up to 18 (minimum 3) patients are expected to be enrolled depending on the observed DLTs.

Not Provided
Interventional
Phase 1
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms
Drug: talazoparib
Talazoparib will be administered orally on a continuous basis. Talazoparib may be taken with or without food. Each cycle will consist of 28 days.
Experimental: talazoparib
0.75 mg/day or 1.0 mg/day
Intervention: Drug: talazoparib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18
March 3, 2019
March 3, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.
  • Able to take oral medications.
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1.
  • Serum or urine pregnancy test (for females of childbearing potential) negative at screening.

Exclusion Criteria:

  • Patients with known symptomatic brain metastases requiring steroids.
  • Major surgery within 4 weeks prior to the first dose of study treatment.
  • Radiation therapy within 4 weeks prior to the first dose of study treatment.
  • Any antitumor systemic cytotoxic therapies and/or treatment with immune modulators within 4 weeks prior to the first dose of study treatment.
  • Previous high dose chemotherapy requiring stem cell rescue.
  • Prior irradiation to >25% of the bone marrow.
  • Active and clinically significant bacterial, fungal, or viral infection
  • Myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure, unstable angina, or unstable cardiac arrhythmia requiring medication.
  • Hypertension that cannot be controlled by medications.
  • Participation in other studies involving investigational drug(s) within 4 weeks prior to the first dose of study treatment.
  • Other acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and would make the patient inappropriate for entry into this study.
  • Fertile male patients and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception and for 180 days after the last dose of investigational product.
  • Breastfeeding at screening or at any time during study participation.
  • 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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Japan
 
 
NCT03343054
C3441030
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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