Recruiting
Phase 2

Tesetaxel

Sponsor:

Genta Incorporated

Code:

NCT01215877

Conditions

Carcinoma, Transitional Cell

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tesetaxel

Study Details

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 ID

NCT01215877

Start date

Sep, 2010

Status verified date

Nov, 2011

Completion date

Dec, 2012

Anticipated

Primary completion date

Sep, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

33 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Primary outcome measure

  • Response rate (revised RECIST) [ Time Frame: 12 months from date of first dose of study medication for last patient enrolled ]

Central Contacts and Locations

Locations

Memorial Sloan-Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Dean F Bajorin, MD

646-422-4333

Principal Investigator:

Dean F Bajorin, MD

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Deborah Kilpatrick

215-955-0017Deborah.Kilpatrick@jefferson.edu

Principal Investigator:

Jean Hoffman-Censits, MD

More Information

Sponsor

Genta Incorporated

Last update posted

Jul 11, 2012

Last verified

Nov, 2011

Keywords

  • Bladder cancer
  • Previously treated patients
  • Tesetaxel
  • Oral taxane

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Genta Incorporated on 2012-07-11.