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

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.

Study Overview

• Status: Unknown
• Conditions: Carcinoma, Transitional Cell
• Intervention / Treatment: Drug: Tesetaxel

• Study Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00152
    • Recruiting
    • San Camillo Forlanini Hospital
    • Contact: Cora N Sternberg, MD, FACP; Email: cstern@mclink.it
    • Principal Investigator: Cora N Sternberg, MD, FACP
• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan-Kettering Cancer Center
      • Contact: Dean F Bajorin, MD; Phone Number: 646-422-4333
      • Principal Investigator: Dean F Bajorin, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital
      • Contact: Deborah Kilpatrick; Phone Number: 215-955-0017; Email: Deborah.Kilpatrick@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

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

Collaborators and Investigators

• Sponsor: Genta Incorporated
• Investigators: Principal Investigator: Dean F Bajorin, MD, Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ANTICIPATED): September 1, 2012
• Study Completion (ANTICIPATED): December 1, 2012

Study Registration Dates

• First Submitted: October 5, 2010
• First Submitted That Met QC Criteria: October 5, 2010
• First Posted (ESTIMATE): October 7, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 11, 2012
• Last Update Submitted That Met QC Criteria: July 9, 2012
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Bladder cancer; Tesetaxel; Previously treated patients; Oral taxane
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell
• Other Study ID Numbers: TOBL204