Tesetaxel for Previously Treated Patients With Bladder Cancer

NCT01215877 | Unknown Phase 2

• 1 other identifier: TOBL204
• Study Type: interventional
• Target: 33
• Locations: 2 countries
• Sites: 3

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

Keywords

Bladder cancer; Previously treated patients; Tesetaxel; Oral taxane

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• ≥ 3-month response rate

  12 months from date of first dose of study medication for last patient enrolled

• Disease control rate

  12 months from date of first dose of study medication for last patient enrolled

• Durable response rate

  12 months from date of first dose of study medication for last patient enrolled

• Duration of response

  12 months from date of first dose of study medication for last patient enrolled

• Time to progression

  12 months from date of first dose of study medication for last patient enrolled

Interventions

Tesetaxel DRUG

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.

Also known as: DJ-927

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genta Incorporated: lead

Study Sites (3)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

San Camillo Forlanini Hospital

Rome, 00152, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Urinary Bladder Neoplasms

Interventions

tesetaxel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Dean F Bajorin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 7, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 11, 2012

Record last verified: 2011-11

Locations

IT (1); US (2)