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An Investigation of TAS-119 Monotherapy

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: NCT02448589
Recruitment Status : Terminated
First Posted : May 19, 2015
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Study Description
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Brief Summary:
A Phase 1, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of TAS-119 in Patients with Advanced Solid Tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: TAS-119 Phase 1

Detailed Description:

This is a Phase 1, open-label, non-randomized, dose escalation study of TAS-119 evaluating the safety, tolerability, PK, pharmacogenomics, pharmacodynamics, and preliminary antitumour activity in patients with advanced and unresectable solid tumours. The study will evaluate TAS-119 monotherapy, employing two sequential phases.

  • A Dose Escalation Phase
  • An Expansion Phase
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of TAS-119 in Patients With Advanced Solid Tumors
Study Start Date : September 2014
Actual Primary Completion Date : August 2019
Actual Study Completion Date : August 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: TAS-119 Monotherapy

Dose Escalation:

A Monotherapy Dose-Escalation Phase Performed in Approximately 5 Dose Levels (3 to 12 Patients Per Dose Level) to Determine the MTD for TAS-119 Given Orally (PO), Twice-Daily (BID) in a 28-Day Treatment Cycle; and:

Dose Expansion:

A Monotherapy Expansion Phase in Which Approximately 40 Additional Patients will be Enrolled to Further Evaluate the Recommended Phase II Dose (RP2D)

 Drug: TAS-119


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: Up to 2.5 Years ]
    Identify the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of TAS-119


Eligibility Criteria
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Information from the National Library of Medicine

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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 include the following:

  1. Is a male or female, ≥ 18 years of age, who has provided written informed consent.
  2. Has histologically or cytologically confirmed advanced, unresectable, metastatic solid tumor(s) for which the patients have no available therapy likely to provide clinical benefit.
  3. Must have an archival FFPE tumor sample available, to be provided to the Sponsor upon request.
  4. In the Expansion Phase: patients should be willing to undergo tumor core biopsy procedure at pre-treatment and on Day 4, Cycle 1 if, in the judgment of the investigator, it is considered clinically safe and appropriate to do so. This requirement is optional but preferred for patients in Dose Escalation.
  5. Has adequate organ function.

Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug. Both males and females and must agree to use effective birth control during the study if conception is possible during this interval.

Exclusion:

  1. Has received prior treatment with TAS-119.
  2. Has received treatment with any proscribed treatments within specified time frames prior to study drug administration.
  3. Has a serious illness or medical condition(s).
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): NCT02448589


Locations
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United States, Ohio
University Hospitals - Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Italy
San Raffaele Hospital
Milano, Italy, 20132
Netherlands
Erasmus MC Cancer Institute
Rotterdam, Netherlands, 3015CE
Spain
START MADRID-FJD, Hospital Fundación Jiménez Díaz
Madrid, Spain, 28040
START Madrid Unidad de Ensayos Fase I
Madrid, Spain, 28050
United Kingdom
The Institute of Cancer Research
Sutton, Surrey, United Kingdom, SM2 5NG
Sponsors and Collaborators
Taiho Oncology, Inc.
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02448589    
Other Study ID Numbers: TAS-119-102
2014-001272-63 ( EudraCT Number )
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Keywords provided by Taiho Oncology, Inc.:
Advanced Solid Tumors
Dose Escalation
Dose Expansion
 MTD
TAS-119
Aurora A Kinase Inhibitor
Additional relevant MeSH terms:
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TAS-119
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action