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Tesetaxel for Previously Treated Patients With Bladder Cancer

NCT01215877 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2012-07-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Genta Incorporated

    lead INDUSTRY

Principal Investigators

  • Dean F Bajorin, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-09-30
Completion
2012-12-31

Countries

  • United States
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01215877 on ClinicalTrials.gov