Dose-escalating, Safety, Tolerability and PK Study of TAS-119 in Combination With Paclitaxel in Patients With Advanced Solid Tumors
NCT ID: NCT02134067
Last Updated: 2024-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
30 participants
INTERVENTIONAL
2014-08-31
2018-07-31
Brief Summary
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TAS-119 is a novel, selective Aurora A kinase inhibitor, which has previously been demonstrated to enhance the activity of paclitaxel in preclinical studies
Detailed Description
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In nonclinical pharmacology studies TAS-119 significantly enhanced the antitumor activity of the microtubule stabilizer paclitaxel and TAS-119 is being developed for use in combination with paclitaxel.
TAS-119 selectively inhibits the kinase inhibitor Aurora A. AurA regulates cell division by controlling the transition from G2 to M phase. Overexpression of AurA is associated with resistance to taxanes.
The study will be conducted in two sequential phases:
Dose Escalation Phase with the purpose to determine the maximum tolerated dose and the recommended Phase 2 dose of TAS-119 given in combination with paclitaxel
An Expansion Phase in which additional patients will be enrolled to further evaluate the safety and preliminary efficacy of the recommended Phase 2 dose of TAS-119 in combination with paclitaxel, during which a subgroup of patients will be evaluated for DDI between paclitaxel and TAS-119 via PK assessment.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TAS-119
TAS-119 tablets, oral, dose-escalating, 28-day cycle.
Paclitaxel (90mg/m2) is administered IV in combination with TAS-119 in each of the arms.
TAS-119
Paclitaxel
A dose of 90 mg/m2 is used in combination with various doses of TAS-119.
Interventions
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TAS-119
Paclitaxel
A dose of 90 mg/m2 is used in combination with various doses of TAS-119.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Taiho Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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TO-TAS-119-101
Identifier Type: -
Identifier Source: org_study_id