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

Last updated on November 13, 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

- 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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Descriptive Information
Brief Title  ICMJE A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors
Official Title  ICMJE 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
Brief Summary

This is a Phase 1 study which consists of 2 parts; Dose Escalation part and Expansion part.

The dose escalation part is open?label, and evaluates safety, preliminary efficacy and PK 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.

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

The expansion part is designed to assess the efficacy, safety and PK of single-agent talazoparib at RP2D determined in the dose escalation part in adult patients with locally advanced or metastatic breast cancer who have deleterious or suspected deleterious germline BRCA1 or BRCA2 mutations.

In the expansion part, a minimum of 17 patients will be enrolled evaluable for the primary endpoint.

Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neoplasms
  • Breast Neoplasms
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: talazoparib
0.75 mg/day or 1.0 mg/day
Intervention: Drug: talazoparib
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
26
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2017)
18
Estimated Study Completion Date  ICMJE December 28, 2022
Estimated Primary Completion DateJune 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

[Dose Escalation Part]

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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03343054
Other Study ID Numbers  ICMJE C3441030
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:No
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

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 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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