Clinical trial

A Phase I, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability and Pharmacokinetic Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors

Name

TAS-114-102

Description

A Phase I, Open-Label, International, Multicenter, Non-Randomized, Dose-Escalating Safety, Tolerance and Pharmacokinetic Study of Oral Administration of TAS-114 in Combination with S-1 in a Twice Daily Schedule for 14 Days in Patients with Advanced Solid Tumors.

Trial arms

Trial start

2013-03-01

Estimated PCD

2016-12-27

Trial end

2017-09-30

Status

Completed

Phase

Early phase I

Treatment

TAS-114

TAS-114 is an inhibitor of dUTPase, a gatekeeper protein in pyrimidine-metabolism.

Arms:

Dose Escalation TAS-114 (PART 1), Expansion phase TAS-114 (PART 2)

S-1

S-1 is an oral antimetabolite; a combination of three pharmacological compounds: tegafur (FT), gimeracil (CDHP), and oteracil (Oxo)

Arms:

Dose Escalation TAS-114 (PART 1), Expansion phase TAS-114 (PART 2)

Size

120

Primary endpoint

Identify Maximum Tolerated Dose (MTD) in mg/kg

Up to 2.5 Years

Eligibility criteria

Inclusion Criteria: 1. Has provided written informed consent. 2. Is ≥18 years of age 3. Has histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no standard therapy exists. 4. Expansion Phase only: Has at least one measurable lesion 5. Is able to take medications orally (e.g., no feeding tube). 6. Has adequate organ function 7. Women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug. 8. Is willing and able to comply with scheduled visits and study procedures. Exclusion Criteria: 1. Has received treatment with any proscribed treatments within specified time frames prior to study drug administration. 2. Has a serious illness or medical condition(s) 3. Is receiving concomitant treatment with drugs that may interact with S-1

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}

Updated at

2024-06-27

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug