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STUDY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04635631
Recruitment Status : Completed
First Posted : November 19, 2020
Last Update Posted : January 14, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
A phase1 study to evaluate the PK (single dose and multiple doses) and safety of talazoparib 1 mg Once Daily in Chinese adult participants with advanced solid tumors. A maximum of approximately 15 participants will be enrolled such that approximately 12 evaluable participants complete the study.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: talazoparib Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AN OPEN-LABEL, SINGLE-ARM, PHASE 1 STUDY OF PHARMACOKINETICS, SAFETY AND ANTI-TUMOR ACTIVITY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS
Actual Study Start Date : November 30, 2020
Actual Primary Completion Date : August 8, 2021
Actual Study Completion Date : December 14, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Talazoparib

Arms and Interventions
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Arm Intervention/treatment
Experimental: talazoparib
1 mg QD
 Drug: talazoparib
Talazoparib will be administered orally on a continuous basis. Each cycle will consist of 28 days.


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.50, 1, 2, 4, 8, 24, 48, 96, 168 and 216 hours post dose ]
  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.50, 1, 2, 4, 8, 24, 48, 96, 168 and 216 hours post dose ]
  3. Area under the Concentration-Time Curve (AUC) [ Time Frame: 0, 0.50, 1, 2, 4, 8, 24, 48, 96, 168 and 216 hours post dose ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  4. Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.50, 1, 2, 4, 8, 24, 48, 96, 168 and 216 hours post dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  5. AUC24 [ Time Frame: 0, 0.5, 1, 2, 4, 8, 24 hours post-dose ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: From time of ICD signed to 28 days after last dose ]
    Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 4.03), timing, seriousness, and relationship to talazoparib.

  2. Objective Response-Number of Participants With Objective Response [ Time Frame: Baseline up to 12 months ]
    OR is defined as a complete response (CR) or partial response (PR) according to RECIST v.1.1. recorded from baseline until disease progression or death due to any cause

  3. Duration of Response (DoR) [ Time Frame: Baseline up to 12 months ]
    DOR is the time from first documentation of CR or PR to date of first documentation of objective progression or death.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • Participants with brain metastases.
  • Current or anticipated use of P gp inhibitor and/or inducer within 7 days prior to study intervention from lead-in to end of Cycle 1; concomitant use of potent P gp inhibitor after Cycle 1 until the end of treatment.
  • Prior treatment with a PARP inhibitor.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04635631


Locations
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China, Jilin
Jilin Cancer Hospital
Changchun, Jilin, China, 130000
China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04635631    
Other Study ID Numbers: C3441049
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Talazoparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents