An Investigation of TAS-119 Monotherapy

Taiho Pharma

Status and phase: Terminated; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: TAS-119

Study type: Interventional

Funder types: Industry

Identifiers

NCT02448589

TAS-119-102

2014-001272-63 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

TAS-119 Monotherapy

Experimental group

Description:

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)

Treatment:

Drug: TAS-119