Tesetaxel for Previously Treated Patients With Bladder Cancer

Carcinoma, Transitional Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01215877
• Other study ID #: TOBL204
• Status: Recruiting
• Phase: Phase 2
• First received: October 5, 2010
• Last updated: July 9, 2012
• Start date: September 2010
• Est. completion date: December 2012

Study information

• Verified date: November 2011
• Source: Genta Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell

Intervention

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.

Locations

Country	Name	City	State
Italy	San Camillo Forlanini Hospital	Rome
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	= 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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Safety	Adverse events and clinical laboratory tests	Up to 30 days after the last dose of study medication for a specific patient	Yes