Clinical trial NCT02454062: A Trial of TAS-114 in Combination With S-1
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Phase I
Solid Tumors
Pharmacokinetics
Pharmacodynamics
MTD
Lead sponsor: Taiho Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Identify Maximum Tolerated Dose (MTD) in mg/kg
timeFrame: Up to 2.5 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme University Hospital-ULB
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Genoa
country: Italy
facility: IRCCS San Marino IST
city: Milan
country: Italy
facility: Universita Vita-Salute San Raffaele
city: Bellinzona
country: Switzerland
facility: IOSI Istituto Oncologico della Svizzera Italiana
Study officials:
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