Tesetaxel for Previously Treated Patients With Bladder Cancer

Phase 2

• Conditions: Carcinoma, Transitional Cell

• Registration Number: NCT01215877
• Lead Sponsor: Genta Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-05
• Study First Submitted QC: 2010-10-05
• Study First Posted: 2010-10-07
• Status Verified: 2011-11
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-11
• Primary Completion: 2012-09
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate (revised RECIST)	12 months from date of first dose of study medication for last patient enrolled	Proportion of patients with a confirmed complete or partial response

Secondary Outcome Measures

Name	Time	Method
≥ 3-month response rate	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	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	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	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	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	Up to 30 days after the last dose of study medication for a specific patient	Adverse events and clinical laboratory tests

Trial Locations

Locations (3)

San Camillo Forlanini Hospital; 🇮🇹 Rome, Italy

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States