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Tesetaxel for Previously Treated Patients With Bladder Cancer

Primary Purpose

Carcinoma, Transitional Cell

Status

Unknown status

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Tesetaxel

About this trial

This is an interventional treatment trial for Carcinoma, Transitional Cell focused on measuring Bladder cancer, Previously treated patients, Tesetaxel, Oral taxane

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Memorial Sloan-Kettering Cancer CenterRecruiting
Thomas Jefferson University HospitalRecruiting
San Camillo Forlanini HospitalRecruiting

Outcomes

Primary Outcome Measures

Response rate (revised RECIST)

Proportion of patients with a confirmed complete or partial response

Secondary Outcome Measures

≥ 3-month response rate

Proportion of patients with a confirmed complete or partial response ≥ 3 months in duration

Disease control rate

Proportion of patients with a confirmed complete or partial response of any duration or stable disease ≥ 3 months in duration

Durable response rate

Proportion of subjects with a confirmed complete or partial response ≥ 6 months in duration

Duration of response

Date when response criteria are first met to the date when progression is first documented

Time to progression

Date of first dose of study medication to the date when progression is first documented

Safety

Adverse events and clinical laboratory tests

Full Information

NCT ID

NCT01215877

First Posted

October 5, 2010

Last Updated

July 9, 2012

Sponsor

Genta Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01215877

Brief Title

Tesetaxel for Previously Treated Patients With Bladder Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Unknown status

Study Start Date

September 2010 (undefined)

Primary Completion Date

September 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genta Incorporated

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Transitional Cell

Keywords

Bladder cancer, Previously treated patients, Tesetaxel, Oral taxane

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

33 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Tesetaxel

Other Intervention Name(s)

DJ-927

Intervention Description

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 Information:

Title

Response rate (revised RECIST)

Description

Proportion of patients with a confirmed complete or partial response

Time Frame

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

Secondary Outcome Measure Information:

Title

≥ 3-month response rate

Description

Proportion of patients with a confirmed complete or partial response ≥ 3 months in duration

Time Frame

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

Title

Disease control rate

Description

Proportion of patients with a confirmed complete or partial response of any duration or stable disease ≥ 3 months in duration

Time Frame

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

Title

Durable response rate

Description

Proportion of subjects with a confirmed complete or partial response ≥ 6 months in duration

Time Frame

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

Title

Duration of response

Description

Date when response criteria are first met to the date when progression is first documented

Time Frame

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

Title

Time to progression

Description

Date of first dose of study medication to the date when progression is first documented

Time Frame

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

Title

Safety

Description

Adverse events and clinical laboratory tests

Time Frame

Up to 30 days after the last dose of study medication for a specific patient

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dean F Bajorin, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dean F Bajorin, MD

Phone

646-422-4333

First Name & Middle Initial & Last Name & Degree

Dean F Bajorin, MD

Facility Name

Thomas Jefferson University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Deborah Kilpatrick

Phone

215-955-0017

Deborah.Kilpatrick@jefferson.edu

First Name & Middle Initial & Last Name & Degree

Jean Hoffman-Censits, MD

Facility Name

San Camillo Forlanini Hospital

City

Rome

ZIP/Postal Code

00152

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cora N Sternberg, MD, FACP

cstern@mclink.it

First Name & Middle Initial & Last Name & Degree

Cora N Sternberg, MD, FACP

12. IPD Sharing Statement

Learn more about this trial

Tesetaxel for Previously Treated Patients With Bladder Cancer

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