Tesetaxel for Previously Treated Patients With Bladder Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Carcinoma, Transitional Cell	Drug: Tesetaxel	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Tesetaxel in Subjects Previously Treated With Chemotherapy for Metastatic Transitional Cell Carcinoma of the Urothelium

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

U.S. FDA Resources

Further study details as provided by Genta Incorporated:

Primary Outcome Measures:

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

Secondary Outcome Measures:

≥ 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

Estimated Enrollment:	33
Study Start Date:	September 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215877

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Dean F Bajorin, MD 646-422-4333
Principal Investigator: Dean F Bajorin, MD
United States, Pennsylvania
Thomas Jefferson University Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Deborah Kilpatrick 215-955-0017 Deborah.Kilpatrick@jefferson.edu
Principal Investigator: Jean Hoffman-Censits, MD
Italy
San Camillo Forlanini Hospital	Recruiting
Rome, Italy, 00152
Contact: Cora N Sternberg, MD, FACP cstern@mclink.it
Principal Investigator: Cora N Sternberg, MD, FACP

Sponsors and Collaborators

Genta Incorporated

Investigators

Principal Investigator:

Dean F Bajorin, MD

Memorial Sloan-Kettering Cancer Center

More Information

No publications provided

Responsible Party:	Genta Incorporated
ClinicalTrials.gov Identifier:	NCT01215877 History of Changes
Other Study ID Numbers:	TOBL204
Study First Received:	October 5, 2010
Last Updated:	July 9, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genta Incorporated:

Bladder cancer
Previously treated patients
Tesetaxel
Oral taxane

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Carcinoma
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 21, 2013