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A Phase II Study of Tesetaxel in Subjects Previously Treated With Chemotherapy for Metastatic Transitional Cell Carcinoma of the Urothelium


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Transitional Cell

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Trial Information

A Phase II Study of Tesetaxel in Subjects Previously Treated With Chemotherapy for Metastatic Transitional Cell Carcinoma of the Urothelium


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (revised RECIST)

Outcome Description:

Proportion of patients with a confirmed complete or partial response

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Dean F Bajorin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

TOBL204

NCT ID:

NCT01215877

Start Date:

September 2010

Completion Date:

December 2012

Related Keywords:

  • Carcinoma, Transitional Cell
  • Bladder cancer
  • Previously treated patients
  • Tesetaxel
  • Oral taxane
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania  19131