We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified December 2015 by Taiho Oncology, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02454062
First Posted: May 27, 2015
Last Update Posted: December 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Taiho Oncology, Inc.
  Purpose
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.

Condition Intervention Phase
Advanced Solid Tumors Drug: TAS-114 Drug: S-1 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Taiho Oncology, Inc.:

Primary Outcome Measures:
  • Identify Maximum Tolerated Dose (MTD) in mg/kg [ Time Frame: 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.


Estimated Enrollment: 120
Study Start Date: March 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Escalation TAS-114 (PART 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.
Drug: TAS-114
TAS-114 is an inhibitor of dUTPase, a gatekeeper protein in pyrimidine-metabolism.
Drug: S-1
S-1 is an oral antimetabolite; a combination of three pharmacological compounds: tegafur (FT), gimeracil (CDHP), and oteracil (Oxo)
Experimental: Expansion phase TAS-114 (PART 2)

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
TAS-114 is an inhibitor of dUTPase, a gatekeeper protein in pyrimidine-metabolism.
Drug: S-1
S-1 is an oral antimetabolite; a combination of three pharmacological compounds: tegafur (FT), gimeracil (CDHP), and oteracil (Oxo)

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454062


Contacts
Contact: Takekazu Aoyama, MD PhD +1 (609) 750-5300 aoyama@taihooncology.com
Contact: Taiho Pharmaceutics Europe, Ltd

Locations
Belgium
Erasme University Hospital-ULB Not yet recruiting
Brussels, Belgium, 1070
Contact: Jean-Luc Van Laethem, MD PhD    +32 2 555 3712      
Principal Investigator: Jean-Luc Van Laethem, MD PhD         
France
Institut Gustave Roussy Not yet recruiting
Villejuif, France, 94805
Contact: Jean-Charles Soria, MD    +33 1 42 11 42 96      
Principal Investigator: Jean-Charles Soria, MD         
Italy
IRCCS San Marino IST Not yet recruiting
Genoa, Italy, 16132
Contact: Alberto Sobrero, MD    +39 010 5554839      
Principal Investigator: Alberto Sobrero, MD         
Universita Vita-Salute San Raffaele Recruiting
Milan, Italy, 20132
Contact: Luca Gianni, MD    +39 02 264 365 29      
Principal Investigator: Luca Gianni, MD         
Switzerland
IOSI Istituto Oncologico della Svizzera Italiana Recruiting
Bellinzona, Switzerland, 6500
Contact: Cristiana Sessa, Dr. Med.    +41 (0) 91 811 90 39    cristiana.sessa@eoc.ch   
Principal Investigator: Cristiana Sessa, Dr. Med.         
Sponsors and Collaborators
Taiho Oncology, Inc.
Investigators
Study Director: Elvira Klissourska, PhD
  More Information

Publications:

Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02454062     History of Changes
Other Study ID Numbers: TAS-114-102
2012-002674-31 ( EudraCT Number )
First Submitted: May 11, 2015
First Posted: May 27, 2015
Last Update Posted: December 22, 2015
Last Verified: December 2015

Keywords provided by Taiho Oncology, Inc.:
Phase I
Solid Tumors
Pharmacokinetics
Pharmacodynamics
MTD