Advanced Solid Tumors
Conditions
Keywords
Phase I, Solid Tumors, Pharmacokinetics, Pharmacodynamics, MTD
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.
Interventions
DRUGTAS-114
TAS-114 is an inhibitor of dUTPase, a gatekeeper protein in pyrimidine-metabolism.
DRUGS-1
S-1 is an oral antimetabolite; a combination of three pharmacological compounds: tegafur (FT), gimeracil (CDHP), and oteracil (Oxo)
Sponsors
Taiho Oncology, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium, France, Italy, Switzerland
Outcome results
None listed