Study of Teysuno (S-1) Combined With Epirubicin and Oxaliplatin in Patients With Advanced Solid Tumors

NCT02867397 | Completed Phase 1

• 1 other identifier: TPU-S1119
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patients With Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (1)

• The highest dose level at which less than 33% of the patients experienced a dose-limiting toxicity (DLT) during Cycle 1.

  21 days

Study Arms (1)

Teysuno (S1) in combination with epirubicin and oxaliplatin

OTHER

Drug: Teysuno (S1) in combination with epirubicin and oxaliplatin

Interventions

Teysuno (S1) in combination with epirubicin and oxaliplatin DRUG

Teysuno (S1) in combination with epirubicin and oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5 x ULN; if liver function abnormalities were due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) ≤5 x ULN.
• Total serum bilirubin of ≤1.5 x ULN.
• Absolute neutrophil count of ≥1,500/mm3 (ie, ≥1.5 x 109/L by International Units \[IU\]) (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor (G-CSF).
• Platelet count ≥100,000/mm3 (IU: ≥100 x 109/L) (excluding measurements obtained within 7 days after transfusion).
• Hemoglobin value of ≥9.0 g/dL (excluding measurements obtained within 7 days after transfusion).

You may not qualify if:

• 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-1.
• 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.
• Current enrollment in another interventional clinical study.
• Has a serious illness or medical condition(s) including, but not limited to, the following:
• Known brain metastasis or leptomeningeal metastasis.
• Known acute systemic infection.
• Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, pulmonary embolism, or deep vein thrombosis within the last 12 months.

Sponsors & Collaborators

• Disphar International B.V.: lead

MeSH Terms

Interventions

tegafur-gimeracil-oteracil; S 1 (combination); Epirubicin; Oxaliplatin

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Coordination Complexes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 15, 2016
• Study Start: January 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 15, 2016

Record last verified: 2016-08