A Phase 1, Open-Label, Non-Randomized, Dose-Finding, Safety and Tolerability Study of Orally Administered Teysuno (S-1) in Combination With Epirubicin and Oxaliplatin in Patients With Advanced Solid Tumors

Disphar International B.V.0 sites25 target enrollmentJanuary 2012

ConditionsPatients With Advanced or Metastatic Solid Tumors

InterventionsTeysuno (S1) in combination with epirubicin and oxaliplatin

DrugsTeysuno (S1) in combination with epirubicin and oxaliplatin

Overview

Phase: Phase 1
Intervention: Teysuno (S1) in combination with epirubicin and oxaliplatin
Conditions: Patients With Advanced or Metastatic Solid Tumors
Sponsor: Disphar International B.V.
Enrollment: 25
Primary Endpoint: The highest dose level at which less than 33% of the patients experienced a dose-limiting toxicity (DLT) during Cycle 1.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The goal of the current study was to investigate the safety and determine the maximum tolerated dose (MTD) of S-1 in combination with oxaliplatin and epirubicin in patients with advanced or metastatic solid tumors.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

August 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Investigators

Sponsor

Disphar International B.V.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Had given written informed consent.
•Was ≥18 years of age.
•Had advanced or metastatic solid tumor(s) for which no established curative therapy exists.
•Had received any number of prior therapies for advanced or metastatic disease.
•Was able to take medications orally.
•Had ECOG performance status 0 or 1 on Cycle 1, Day 1
•Had a life expectancy of at least 3 months.
•Had LVEF ≥ the LLN for the institution.
•Had serum troponin T and CPK-MB values ≤ ULN for the institution.
•Had adequate organ function as defined by the following criteria:

Exclusion Criteria

•Has had treatment with any of the following within the specified time frame prior to study drug administration:
•Major surgery within prior 4 weeks (the surgical incision should be fully healed prior to study drug administration).
•Radiotherapy within prior 4 weeks.
•\>25% of marrow-bearing bone radiated (Pre-Amendment 3).
•Any chemotherapy within prior 3 weeks.
•Previously received oxaliplatin or S-
•Previously received epirubicin with cumulative dose \>350 mg/m2 (patients who have received epirubicin with cumulative dose ≤350 mg/m2 as adjuvant therapy are allowed to enroll).
•Extensive prior exposure to other anthracycline or anthracenedione agents (ie, prior cumulative doxorubicin exposure of ≥450 mg/m2 or prior mitoxantrone exposure of \>100 mg/m2)
•Received trastuzumab (cardiotoxic agent) within prior 24 weeks.
•Any investigational agent received either concurrently or within the last 30 days.