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UNKNOWNPHASE2

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

NCT01215877•Genta Incorporated

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•At least 18 years of age
•Histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis
•Measurable disease (revised RECIST; Version 1.1)
•Karnofsky performance status ≥ 60%
•Previously treated with not more than 1 doublet or triplet regimen and that regimen contained gemcitabine and a platinum agent
•Adequate bone marrow, hepatic, and renal function, as specified in the protocol
•At least 4 weeks and recovery from effects of prior surgery, prior radiotherapy, or other therapy with an approved or investigational agent
•Ability to swallow an oral solid-dosage form of medication

Exclusion Criteria

•Known metastasis or symptoms of metastasis to the central nervous system
•Significant medical disease other than cancer
•Presence of neuropathy \> Grade 1 (NCI CTC, Version 4.0)
•Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid
•Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity

Locations (3)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

San Camillo Forlanini Hospital

Rome, Italy

Key Dates

Start Date

September 1, 2010

Primary Completion Date

September 1, 2012

Completion Date

December 1, 2012

Last Updated

July 11, 2012

Enrollment

ESTIMATED participants

Conditions

Carcinoma, Transitional Cell

Interventions

Tesetaxel

DRUG

A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

NCT03219333

Carcinoma, Transitional CellUrinary Bladder Neoplasms+5 more

View study

TERMINATEDPHASE3

A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection

NCT02450331

Carcinoma, Transitional Cell

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Tesetaxel for Previously Treated Patients With Bladder Cancer

Inclusion Criteria

Exclusion Criteria

A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection

Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer

TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium

Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder Cancer