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

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: TAS-114; Drug: S-1

• Registration Number: NCT02454062
• Lead Sponsor: Taiho Oncology, Inc.

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.

Detailed Description

This is an open-label, non-randomized, dose-escalation Phase I study of TAS-114 administered in combination with S-1, evaluating the safety, tolerability, pharmacokinetics and preliminary antitumor activity of the TAS-114/S-1 regimen in patients with advanced solid tumors.

The study will be conducted in two parts: a Dose-Escalation Phase (Part 1) to determine the MTD; and an Expansion Phase (Part 2) to further evaluate the safety and preliminary efficacy with the MTD. Patients will receive the study medication according to the proposed treatment schedule until disease progression (PD), occurrence of intolerable side effects, removal by the Investigator or withdrawal of consent. A patient is considered discontinued from study treatment when TAS-114 is discontinued.

Male or female patients age 18 years or older with confirmed advanced solid tumor(s) for which no standard therapy exists.

TAS-114/S-1 will be administered BID for 14 days followed by a 7-day recovery period, every 21 days (1 cycle) in patients with advanced solid tumors.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-27
• Primary Completion: 2016-12-27
• Study Completion: 2017-09-30
• Status Verified: 2020-02
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Expansion phase TAS-114 (PART 2)	TAS-114	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.
Dose Escalation TAS-114 (PART 1)	TAS-114	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.
Dose Escalation TAS-114 (PART 1)	S-1	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.
Expansion phase TAS-114 (PART 2)	S-1	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.

Primary Outcome Measures

Name	Time	Method
Identify Maximum Tolerated Dose (MTD) in mg/kg	Up to 2.5 Years	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.

Trial Locations

Locations (5)

Erasme University Hospital-ULB; 🇧🇪 Brussels, Belgium

IRCCS San Marino IST; 🇮🇹 Genoa, Italy

IOSI Istituto Oncologico della Svizzera Italiana; 🇨🇭 Bellinzona, Switzerland

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Universita Vita-Salute San Raffaele; 🇮🇹 Milan, Italy