Dose-escalating, Safety, Tolerability and PK Study of TAS-119 in Combination With Paclitaxel in Patients With Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

The purpose of this study is to determine the safety of TAS-119 and determine the most appropriate dose in combination with Paclitaxel for subsequent studies in patients with advanced solid tumors. TAS-119 is a novel, selective Aurora A kinase inhibitor, which has previously been demonstrated to enhance the activity of paclitaxel in preclinical studies

Key facts

Study ID

NCT02134067

Run by

Taiho Oncology, Inc.

People needed

30

Starts

2014-08-01

Expected to finish

2018-07-01

Last updated by the study team

2024-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is a male or female ≥ 18 years of age, that has provided written informed consent.
• Has histologically or cytologically confirmed advanced, unresectable metastatic solid tumor(s) for which the patients have no available therapy likely to provide clinical benefit, or for which paclitaxel is considered a standard of care.
• Has adequate organ function as defined by the following criteria:
• Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3.0 × upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) ≤ 5 × ULN.
• Total serum bilirubin ≤ 1.5 × ULN.
• Absolute neutrophil count ≥ 1,500/mm3 (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor [G-CSF]).
• Platelet count ≥ 100,000/mm3 (IU: ≥ 100 × 109/L) (excluding measurements obtained within 7 days after a transfusion of platelets).
• Hemoglobin ≥ 9.0 g/dL
• Total serum creatinine ≤ 1.5 × ULN
• Serum albumin ≥ 3.0 mg/dL.

You may not qualify if…

• Previous inability to tolerate any dose of paclitaxel (i.e., the subject required a paclitaxel dose reduction or discontinuation).
• Has received any treatments prohibited in this trial within specified time frames
• Has a serious illness or medical condition(s) that would affect safety or tolerability of the study treatments
• Has history of Grade 2 or greater peripheral neuropathy during the 3 months prior to enrollment.
• Has known hypersensitivity to TAS-119 or its components.
• Has known hypersensitivity to Cremophor® EL, paclitaxel or its components.
• Is a pregnant or lactating female.

Where it is running

• University of Colorado Hospital Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Washington University School of Medicine Division of Oncology Siteman Cancer Center — St Louis, Missouri, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.