NCT01610479

Brief Summary

This is a phase 1 study of TAS-114 in combination with S-1 in patients with advanced solid tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

4.7 years

First QC Date

May 25, 2012

Last Update Submit

August 2, 2017

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of TAS-114 when used in combination with S-1

    4 years

Secondary Outcomes (4)

  • Pharmacokinetic profiles (peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of TAS-114, S-1 components and its metabolite)

    4 years

  • Response rate

    4 years

  • Disease control rate

    4 years

  • Progression free survival

    4 years

Study Arms (1)

TAS-114/S-1

EXPERIMENTAL

TAS-114 plus S-1

Drug: TAS-114 + S-1

Interventions

TAS-114 + S-1DRUG
TAS-114/S-1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Life expectancy of at least 3 months
  • Histological or cytological documentation of advanced solid tumors
  • ECOG Performance Status of ≤ 1 (ECOG: Eastern Cooperative Oncology Group)
  • Adequate bone marrow, liver and renal function
  • Women of childbearing potential and men must agree to use adequate contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site 01

Kashiwanoha, Kashiwa-shi, Chiba, 277-8577, Japan

Location

Related Publications (1)

  • Doi T, Yoh K, Shitara K, Takahashi H, Ueno M, Kobayashi S, Morimoto M, Okusaka T, Ueno H, Morizane C, Okano N, Nagashima F, Furuse J. First-in-human phase 1 study of novel dUTPase inhibitor TAS-114 in combination with S-1 in Japanese patients with advanced solid tumors. Invest New Drugs. 2019 Jun;37(3):507-518. doi: 10.1007/s10637-018-0697-3. Epub 2018 Dec 4.

    PMID: 30511200DERIVED

MeSH Terms

Interventions

TAS-114S 1 (combination)

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2012

First Posted

June 4, 2012

Study Start

June 1, 2012

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

August 4, 2017

Record last verified: 2017-08

Locations

JP(1)