Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-03-31
Study Completion Date
2017-09-30
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Advanced Solid Tumors
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
TAS-114
Intervention Type
DRUG
TAS-114 is an inhibitor of dUTPase, a gatekeeper protein in pyrimidine-metabolism.
S-1
Intervention Type
DRUG
S-1 is an oral antimetabolite; a combination of three pharmacological compounds: tegafur (FT), gimeracil (CDHP), and oteracil (Oxo)
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.
Group Type
EXPERIMENTAL
TAS-114
Intervention Type
DRUG
TAS-114 is an inhibitor of dUTPase, a gatekeeper protein in pyrimidine-metabolism.
S-1
Intervention Type
DRUG
S-1 is an oral antimetabolite; a combination of three pharmacological compounds: tegafur (FT), gimeracil (CDHP), and oteracil (Oxo)
Interventions
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TAS-114
TAS-114 is an inhibitor of dUTPase, a gatekeeper protein in pyrimidine-metabolism.
Intervention Type
DRUG
S-1
S-1 is an oral antimetabolite; a combination of three pharmacological compounds: tegafur (FT), gimeracil (CDHP), and oteracil (Oxo)
Intervention Type
DRUG
Eligibility Criteria
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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.
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
2. Has a serious illness or medical condition(s)
3. Is receiving concomitant treatment with drugs that may interact with S-1
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Taiho Oncology, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Erasme University Hospital-ULB
Brussels, , Belgium
Site Status
Institut Gustave Roussy
Villejuif, , France
Site Status
IRCCS San Marino IST
Genoa, , Italy
Site Status
Universita Vita-Salute San Raffaele
Milan, , Italy
Site Status
IOSI Istituto Oncologico della Svizzera Italiana
Bellinzona, , Switzerland
Site Status
Countries
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Belgium
France
Italy
Switzerland
References
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Other Identifiers
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2012-002674-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TAS-114-102
Identifier Type: -
Identifier Source: org_study_id
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