Antineoplastic Agents

All Drugs and Chemicals

Taxane

Oral Taxane

The first purpose of this study is to determine how the body absorbs, metabolizes, and eliminates a single dose of BMS-275183 (labeled with radioactive carbon). Secondly, to measure the levels of BMS-275183 in your blood, study the safety of the drug, and to see what effects it has on your cancer.

A Phase I Study of a Single Dose of Radio-labeled BMS-275183 in Patients With Advanced Cancer

Pharmacokinetics and Metabolism of [14C] BMS-275183 in Patients With Advanced Cancer

Bristol-Myers Squibb

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Tesetaxel 27 mg/m2 orally once every 21 days for up to 12 months

Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks in a 28-day cycle for up to 12 months

Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months

Tesetaxel once every 3 weeks

Tesetaxel capsules orally once every 7 days for 3 consecutive weeks in a 28-day cycle; duration of therapy not to exceed 12 months

Tesetaxel once weekly

Andrew D Seidman, MD

Peter Rubin, MD

Joyce O'Shaughnessy, MD

The intravenously administered taxane, paclitaxel, is one of the most commonly employed agents for the treatment of both localized and advanced breast cancer.

Tesetaxel is an orally administered taxane that is in development as first- and second-line treatment for patients with advanced cancers. This study is being undertaken to determine the efficacy and safety of tesetaxel administered as first-line therapy to patients with metastatic breast cancer.

Tesetaxel as First-line Therapy for Metastatic Breast Cancer

A Phase II Study of Tesetaxel as First-line Therapy for Subjects With Metastatic Breast Cancer

Proportion of patients with a confirmed complete or partial response

Proportion of patients with a confirmed complete or partial response of any duration or stable disease ≥ 3 months in duration

Proportion of patients without disease progression 6 months following the first dose of study medication

Proportion of patients with a confirmed complete or partial response ≥ 6 months in duration

Date when response criteria are first met to the date when progression is first documented

Date of first dose of study medication to the date when progression is first documented

Genta Incorporated

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Recurrence

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Pemetrexed

A phase I-II dose ranging study of BMS-275183 (oral taxane) in combination with pemetrexed (Alimta) in patients with recurrent Non-Small Cell Lung Cancer (NSCLC). The safety and efficacy of this combination will be studied.

Oral Taxane in Combination With Pemetrexed (Alimta) in Patients With Recurrent Non-Small Cell Lung Cancer

Phase I Alimta Combination With BMS-275183 (Oral Taxane)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months

In Cycle 1, a dose of 27 mg/m2 will be administered. In subsequent cycles,

* the dose will be increased to 35 mg/m2 in Cycle 2 for subjects who did not have an ANC \< 1,500/mm3, a platelet count \< 100,000/mm3, or a Grade 3 (or higher grade) nonhematologic adverse event considered by the Investigator to be related to protocol therapy (excluding alopecia, nausea, and vomiting) in Cycle 1. The dose is not to exceed the dose of 35 mg/m2 in any cycle subsequent to Cycle 2.
* for all other subjects, the dose administered in Cycle 1 (27 mg/m2) will be administered in all subsequent cycles.

Tesetaxel

Dean F Bajorin, MD

Deborah Kilpatrick

Jean Hoffman-Censits, MD

Cora N Sternberg, MD, FACP

The intravenously administered taxanes, docetaxel and paclitaxel, alone and in combination with other chemotherapy agents are active in patients with advanced and metastatic bladder cancer, and agents of this class are a promising treatment option for some patients.

Tesetaxel is an orally administered taxane that is in development as treatment for subjects with advanced cancers. This study is being conducted to determine the efficacy and safety of tesetaxel administered to patients previously treated with chemotherapy for progressive metastatic transitional cell carcinoma of the urothelium.

Tesetaxel for Previously Treated Patients With Bladder Cancer

A Phase II Study of Tesetaxel in Subjects Previously Treated With Chemotherapy for Metastatic Transitional Cell Carcinoma of the Urothelium

Proportion of patients with a confirmed complete or partial response ≥ 3 months in duration

Proportion of subjects with a confirmed complete or partial response ≥ 6 months in duration

Adverse events and clinical laboratory tests

Gastrointestinal Agents

Esomeprazole

The purpose of this study is to determine what effects Esomeprazole (Nexium) has on increasing or decreasing the amount of oral taxane in the blood, and to determine the safety of oral taxane and effect of oral taxane on the cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase I Study of a Single Dose of Radio-labeled BMS-275183 in Patients With Advanced Cancer	NCT00326131	Cancer	Oral Taxane	18 Years -	Bristol-Myers Squibb
Tesetaxel as First-line Therapy for Metastatic Breast Cancer	NCT01221870	Breast Neoplasm	Tesetaxel once ... Tesetaxel once ...	18 Years -	Genta Incorporated
Oral Taxane in Combination With Pemetrexed (Alimta) in Patients With Recurrent Non-Small Cell Lung Cancer	NCT00103831	Non-small Cell ...	Oral Taxane	18 Years -	Bristol-Myers Squibb
Tesetaxel for Previously Treated Patients With Bladder Cancer	NCT01215877	Carcinoma, Tran...	Tesetaxel	18 Years -	Genta Incorporated
A Phase I Study of BMS-275183 (Oral Taxane) Given on a Daily Schedule in Combination With Esomeprazole (Nexium) in Patients With Advanced Cancer	NCT00332748	Cancer	Oral Taxane	18 Years -	Bristol-Myers Squibb

Spots Global Cancer Trial Database for oral taxane

Every month we try and update this database with for oral taxane 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 oral taxane

Every month we try and update this database with for oral taxane 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 oral taxane 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.