Tesetaxel for Previously Treated Patients With Bladder Cancer

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Carcinoma, Transitional Cell

Intervention / Treatment
-----------------
* Drug: Tesetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tesetaxel|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (revised RECIST) | Proportion of patients with a confirmed complete or partial response | 12 months from date of first dose of study medication for last patient enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ≥ 3-month response rate | Proportion of patients with a confirmed complete or partial response ≥ 3 months in duration | 12 months from date of first dose of study medication for last patient enrolled | 
| Disease control rate | Proportion of patients with a confirmed complete or partial response of any duration or stable disease ≥ 3 months in duration | 12 months from date of first dose of study medication for last patient enrolled | 
| Durable response rate | Proportion of subjects with a confirmed complete or partial response ≥ 6 months in duration | 12 months from date of first dose of study medication for last patient enrolled | 
| Duration of response | Date when response criteria are first met to the date when progression is first documented | 12 months from date of first dose of study medication for last patient enrolled | 
| Time to progression | Date of first dose of study medication to the date when progression is first documented | 12 months from date of first dose of study medication for last patient enrolled | 
| Safety | Adverse events and clinical laboratory tests | Up to 30 days after the last dose of study medication for a specific patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder cancer, Previously treated patients, Tesetaxel, Oral taxane