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

• Status: Terminated
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Oncology, Inc.
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

1. Is a male or female ≥ 18 years of age, that has provided written informed consent.

2. 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.

3. 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.

Exclusion Criteria:

1. Previous inability to tolerate any dose of paclitaxel (i.e., the subject required a paclitaxel dose reduction or discontinuation).

2. Has received any treatments prohibited in this trial within specified time frames

3. Has a serious illness or medical condition(s) that would affect safety or tolerability of the study treatments

4. Has history of Grade 2 or greater peripheral neuropathy during the 3 months prior to enrollment.

5. Has known hypersensitivity to TAS-119 or its components.

6. Has known hypersensitivity to Cremophor® EL, paclitaxel or its components.

7. Is a pregnant or lactating female.