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

This study is not yet open for participant recruitment.
Verified November 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT03343054
First Posted: November 17, 2017
Last Update Posted: November 24, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose

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.


Condition Intervention Phase
Neoplasms Drug: talazoparib Phase 1

Study Type: Interventional
Study Design: Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of participants with Dose-limiting toxicities (DLT) [ Time Frame: Baseline up to 28 days ]
    Number of participants with Dose-limiting toxicities (DLT)


Secondary Outcome Measures:
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, hours post-dose ]
    Maximum Observed Plasma Concentration (Cmax)

  • Area under the Concentration-Time Curve (AUC) [ Time Frame: 0, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 168 hours post-dose ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  • Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 168 hours post-dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 168 hours post-dose ]
    Time to Reach Maximum Observed Plasma Concentration (Tmax)

  • 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.


Estimated Enrollment: 18
Anticipated Study Start Date: January 15, 2018
Estimated Study Completion Date: March 3, 2019
Estimated Primary Completion Date: March 3, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: talazoparib
0.75 mg/day or 1.0 mg/day
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 120 Years   (Adult, Senior)
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.
  • 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.
  Contacts and Locations
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): NCT03343054


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03343054     History of Changes
Other Study ID Numbers: C3441030
First Submitted: November 11, 2017
First Posted: November 17, 2017
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
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/data_requests

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Phase 1
talazoparib
PF-06944076
MDV3800
BMN673
PARP inhibitor
Japanese
solid tumors
C3441030

Additional relevant MeSH terms:
Poly(ADP-ribose) Polymerase Inhibitors
Talazoparib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents