Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Taxane

TAS-119

Tubulin Modulators

Antimitotic Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

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.

A dose of 90 mg/m2 is used in combination with various doses of TAS-119.

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

Background and rationale for study:

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.

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

A Phase 1, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability and Pharmacokinetic Study of TAS-119 in Combination With Paclitaxel in Patients With Advanced Solid Tumors

During Dose Escalation Phase PK blood samples will be collected from each arm during Cycle 1 (predose up to 24 hours post-dose). In the Expansion Phase, the first 12 patients (DDI Subgroup) of each arm will undergo PK sampling in Cycle 1 (predose up to 24 hours) and Cycle 2 (predose up to 48 hours post-dose).

Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 will be used.

The safety and tolerability of TAS-119 will be evaluated by the number and severity of adverse events, vital signs, physical exam, and clinical laboratory assessments.

The determination of antitumor efficacy will be based on objective tumor assessments made by the investigator according to RECIST guidelines (version 1.1, 2009).

Taiho Oncology, Inc.

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Adjuvants, Anesthesia

Central Nervous System Depressants

Psychotropic Drugs

Midazolam

Anesthetics

Hypnotics and Sedatives

Anti-Anxiety Agents

Anesthetics, Intravenous

Anesthetics, General

GABA Modulators

Neurotransmitter Agents

LY3295668 erbumine administered orally (Part I).

Approximately the first 10 participants enrolled in this arm will be administered midazolam.

LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part II).

LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).

LY3295668 Erbumine

Administered according to label instructions.

Endocrine therapy

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

The reason for this study is to determine the recommended phase 2 dose of the study drug LY3295668 erbumine in participants with breast cancer that has spread to other parts of the body.

A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body

A Phase 1b Study of Aurora A Kinase Inhibitor LY3295668 Erbumine in Monotherapy and Combination Therapy in Patients With Metastatic Breast Cancer Post CDK4/6 Inhibitor and Endocrine Therapy

Number of Participants with Dose Reductions

Part II: Number of Participants with DLTs

PK: AUC of LY3295668 in Combination with Endocrine Therapy

PK: AUC of Endocrine Therapy in Combination with LY3295668

PK: AUC of Midazolam in Combination with LY3295668

Eli Lilly and Company

Rare Diseases

Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antirheumatic Agents

Cyclophosphamide

Topotecan

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Topoisomerase I Inhibitors

LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV).

LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.

The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.

A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma

A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 Erbumine as a Single Agent and in Combination in Patients With Relapsed/Refractory Neuroblastoma

PK: AUC of LY3295668 in Combination with topotecan and cyclophosphamide

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dose-escalating, Safety, Tolerability and PK Study of TAS-119 in Combination With Paclitaxel in Patients With Advanced Solid Tumors	NCT02134067	Advanced Solid ...	TAS-119 Paclitaxel	18 Years -	Taiho Oncology, Inc.
A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body	NCT03955939	Metastatic Brea...	LY3295668 Erbum... Endocrine thera... Midazolam	18 Years -	Eli Lilly and Company
A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body	NCT03955939	Metastatic Brea...	LY3295668 Erbum... Endocrine thera... Midazolam	18 Years -	Eli Lilly and Company
Dose-escalating, Safety, Tolerability and PK Study of TAS-119 in Combination With Paclitaxel in Patients With Advanced Solid Tumors	NCT02134067	Advanced Solid ...	TAS-119 Paclitaxel	18 Years -	Taiho Oncology, Inc.
A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma	NCT04106219	Neuroblastoma	LY3295668 Erbum... Topotecan Cyclophosphamid...	2 Years - 21 Years	Eli Lilly and Company
Dose-escalating, Safety, Tolerability and PK Study of TAS-119 in Combination With Paclitaxel in Patients With Advanced Solid Tumors	NCT02134067	Advanced Solid ...	TAS-119 Paclitaxel	18 Years -	Taiho Oncology, Inc.

Spots Global Cancer Trial Database for aura

Every month we try and update this database with for aura cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for aura

Every month we try and update this database with for aura cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for aura cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.