A Trial of TAS-114 in Combination With S-1

NCT02454062 | Completed Phase 1

• 2 other identifiers: TAS-114-1022012-002674-31
• Study Type: interventional
• Target: 120
• Locations: 4 countries
• Sites: 5

Brief Summary

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.

Conditions

Advanced Solid Tumors

Keywords

Phase I; Solid Tumors; Pharmacokinetics; Pharmacodynamics; MTD

Outcome Measures

Primary Outcomes (1)

• Identify Maximum Tolerated Dose (MTD) in mg/kg

  To investigate the safety and determine the maximum tolerated dose (MTD) of TAS-114 in combination with S-1 in patients with advanced solid tumor(s) for which no standard therapy exists.

  Up to 2.5 Years

Study Arms (2)

Dose Escalation TAS-114 (PART 1)

EXPERIMENTAL

Each cycle will be 21 days: 14 days of treatment and 7 days recovery. TAS-114 and S-1 will be escalated according to a defined dosing table and specific DLT criteria.

Drug: TAS-114; Drug: S-1

Expansion phase TAS-114 (PART 2)

EXPERIMENTAL

The TAS-114 and S-1 MTD established in the Dose Escalation Phase will be administered BID for 14 days followed by a 7 day recovery period. This regimen is repeated every 21 days thereafter. Approximately 40 to 60 evaluable patients will be enrolled in the Expansion Phase. PGx, PD and PK analysis will be performed based on specific criteria.

Drug: TAS-114; Drug: S-1

Interventions

TAS-114 DRUG

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

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

S-1 DRUG

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has provided written informed consent.
• Is ≥18 years of age
• Has histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no standard therapy exists.
• Expansion Phase only: Has at least one measurable lesion
• Is able to take medications orally (e.g., no feeding tube).
• Has adequate organ function
• Women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug.
• Is willing and able to comply with scheduled visits and study procedures.

You may not qualify if:

• Has received treatment with any proscribed treatments within specified time frames prior to study drug administration.
• Has a serious illness or medical condition(s)
• Is receiving concomitant treatment with drugs that may interact with S-1

Sponsors & Collaborators

• Taiho Oncology, Inc.: lead

Study Sites (5)

Erasme University Hospital-ULB

Brussels, 1070, Belgium

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

IRCCS San Marino IST

Genoa, 16132, Italy

Location

Universita Vita-Salute San Raffaele

Milan, 20132, Italy

Location

IOSI Istituto Oncologico della Svizzera Italiana

Bellinzona, 6500, Switzerland

Location

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MeSH Terms

Interventions

TAS-114; S 1 (combination)

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 27, 2015
• Study Start: March 1, 2013
• Primary Completion: December 27, 2016
• Study Completion: September 30, 2017
• Last Updated: September 4, 2024

Record last verified: 2024-08

Locations

FR (1); IT (2); BE (1); CH (1)