Tesetaxel for Previously Treated Patients With Bladder Cancer

NCT ID: NCT01215877

Last Updated: 2012-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-12-31

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.

Conditions

Carcinoma, Transitional Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

DJ-927

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genta Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dean F Bajorin, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status: RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

San Camillo Forlanini Hospital

Rome, , Italy

Site Status: RECRUITING

Countries

United States; Italy

Facility Contacts

Dean F Bajorin, MD

Role: primary

646-422-4333

Deborah Kilpatrick

Role: primary

Deborah.Kilpatrick@jefferson.edu

215-955-0017

Cora N Sternberg, MD, FACP

Role: primary

cstern@mclink.it

Other Identifiers

TOBL204

Identifier Type: -

Identifier Source: org_study_id