An Investigation of TAS-119 Monotherapy

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02448589
• Other study ID #: TAS-119-102
• Secondary ID: 2014-001272-63
• Status: Terminated
• Phase: Phase 1
• Start date: September 2014
• Est. completion date: August 2019

Study information

• Verified date: February 2020
• Source: Taiho Oncology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 74
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• TAS-119

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milano
Netherlands	Erasmus MC Cancer Institute	Rotterdam
Spain	START Madrid Unidad de Ensayos Fase I	Madrid
Spain	START MADRID-FJD, Hospital Fundación Jiménez Díaz	Madrid
United Kingdom	The Institute of Cancer Research	Sutton	Surrey
United States	University Hospitals - Seidman Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Oncology, Inc.

Countries where clinical trial is conducted

United States,  Italy,  Netherlands,  Spain,  United Kingdom, 

References & Publications (19)

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.03	Identify the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of TAS-119	Up to 2.5 Years