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Tesetaxel for Previously Treated Patients With Bladder Cancer

This study is currently recruiting participants.
Verified November 2011 by Genta Incorporated
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT01215877
First received: October 5, 2010
Last updated: July 9, 2012
Last verified: November 2011
History of Changes

October 5, 2010
July 9, 2012
September 2010
September 2012   (final data collection date for primary outcome measure)
Response rate (revised RECIST) [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ] [ Designated as safety issue: No ]
Proportion of patients with a confirmed complete or partial response
Same as current
Complete list of historical versions of study NCT01215877 on ClinicalTrials.gov Archive Site
  • ≥ 3-month response rate [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ] [ Designated as safety issue: No ]
    Proportion of patients with a confirmed complete or partial response ≥ 3 months in duration
  • Disease control rate [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ] [ Designated as safety issue: No ]
    Proportion of patients with a confirmed complete or partial response of any duration or stable disease ≥ 3 months in duration
  • Durable response rate [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ] [ Designated as safety issue: No ]
    Proportion of subjects with a confirmed complete or partial response ≥ 6 months in duration
  • Duration of response [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ] [ Designated as safety issue: No ]
    Date when response criteria are first met to the date when progression is first documented
  • Time to progression [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ] [ Designated as safety issue: No ]
    Date of first dose of study medication to the date when progression is first documented
  • Safety [ Time Frame: Up to 30 days after the last dose of study medication for a specific patient ] [ Designated as safety issue: Yes ]
    Adverse events and clinical laboratory tests
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Transitional Cell
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.
Other Name: DJ-927
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
33
December 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States,   Italy
 
NCT01215877
TOBL204
No
Genta Incorporated
Genta Incorporated
Not Provided
Principal Investigator: Dean F Bajorin, MD Memorial Sloan-Kettering Cancer Center
Genta Incorporated
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP