Tesetaxel for Previously Treated Patients With Bladder Cancer

Sponsor

Genta Incorporated (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01215877

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Transitional Cell	Drug: Tesetaxel	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Sep 1, 2010

Anticipated Primary Completion Date :

Sep 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Outcome Measures

Primary Outcome Measures

Response rate (revised RECIST) [12 months from date of first dose of study medication for last patient enrolled]
Proportion of patients with a confirmed complete or partial response

Secondary Outcome Measures

≥ 3-month response rate [12 months from date of first dose of study medication for last patient enrolled]
Proportion of patients with a confirmed complete or partial response ≥ 3 months in duration
Disease control rate [12 months from date of first dose of study medication for last patient enrolled]
Proportion of patients with a confirmed complete or partial response of any duration or stable disease ≥ 3 months in duration
Durable response rate [12 months from date of first dose of study medication for last patient enrolled]
Proportion of subjects with a confirmed complete or partial response ≥ 6 months in duration
Duration of response [12 months from date of first dose of study medication for last patient enrolled]
Date when response criteria are first met to the date when progression is first documented
Time to progression [12 months from date of first dose of study medication for last patient enrolled]
Date of first dose of study medication to the date when progression is first documented
Safety [Up to 30 days after the last dose of study medication for a specific patient]
Adverse events and clinical laboratory tests

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065
2	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
3	San Camillo Forlanini Hospital	Rome		Italy	00152