Tesetaxel for Previously Treated Patients With Bladder Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01215877|
Recruitment Status : Unknown
Verified November 2011 by Genta Incorporated.
Recruitment status was: Recruiting
First Posted : October 7, 2010
Last Update Posted : July 11, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Transitional Cell||Drug: Tesetaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Tesetaxel in Subjects Previously Treated With Chemotherapy for Metastatic Transitional Cell Carcinoma of the Urothelium|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||December 2012|
- 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 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,
- Response rate (revised RECIST) [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ]Proportion of patients with a confirmed complete or partial response
- ≥ 3-month response rate [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ]Proportion of patients with a confirmed complete or partial response ≥ 3 months in duration
- Disease control rate [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ]Proportion of patients with a confirmed complete or partial response of any duration or stable disease ≥ 3 months in duration
- Durable response rate [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ]Proportion of subjects with a confirmed complete or partial response ≥ 6 months in duration
- Duration of response [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ]Date when response criteria are first met to the date when progression is first documented
- Time to progression [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ]Date of first dose of study medication to the date when progression is first documented
- Safety [ Time Frame: Up to 30 days after the last dose of study medication for a specific patient ]Adverse events and clinical laboratory tests
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215877
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Dean F Bajorin, MD 646-422-4333|
|Principal Investigator: Dean F Bajorin, MD|
|United States, Pennsylvania|
|Thomas Jefferson University Hospital||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Deborah Kilpatrick 215-955-0017 Deborah.Kilpatrick@jefferson.edu|
|Principal Investigator: Jean Hoffman-Censits, MD|
|San Camillo Forlanini Hospital||Recruiting|
|Rome, Italy, 00152|
|Contact: Cora N Sternberg, MD, FACP firstname.lastname@example.org|
|Principal Investigator: Cora N Sternberg, MD, FACP|
|Principal Investigator:||Dean F Bajorin, MD||Memorial Sloan Kettering Cancer Center|