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Tesetaxel as First-line Therapy for Metastatic Breast Cancer

Primary Purpose

Breast Neoplasm

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Tesetaxel once every 3 weeks

Tesetaxel once weekly

About this trial

This is an interventional treatment trial for Breast Neoplasm focused on measuring Metastatic breast cancer, First-line therapy, Tesetaxel, Oral taxane

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Primary Inclusion Criteria:

Female
At least 18 years of age
Histologically or cytologically confirmed adenocarcinoma of the breast
Stage IV disease
HER2 status negative
Measurable disease (revised RECIST; Version 1.1)
Eastern Cooperative Oncology Group performance status 0 or 1
Life expectancy of at least 3 months
Chemotherapy naïve or 1 prior chemotherapy regimen in the adjuvant setting (Prior taxane-based adjuvant therapy allowed provided patient had a disease-free interval of at least 12 months after completing this adjuvant therapy)
Prior hormonal therapy, aromatase inhibitor therapy, and immunotherapy allowed
Prior radiotherapy in the adjuvant setting allowed provided that less than 25% of the bone marrow had been irradiated
Adequate bone marrow, hepatic, and renal function, as specified in the protocol
At least 4 weeks and recovery from effects of prior surgery, hormonal therapy, aromatase inhibitor therapy, immunotherapy, radiotherapy, or other therapy with an approved or investigational agent
Ability to swallow an oral solid-dosage form of medication

Primary Exclusion Criteria:

Known metastasis to the central nervous system
History of other malignancy within the last 5 years other than curatively treated basal and squamous cell carcinoma of the skin or carcinoma of the cervix in situ
Significant medical disease other than Stage IV breast cancer
Presence of neuropathy > Grade 1 (NCI CTC, Version 4.0)
History of hypersensitivity to a taxane
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
The Moses H. Cone Regional Cancer CenterRecruiting
The West Clinic
Texas Oncology - Baylor Charles A. Sammons Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Tesetaxel once every 3 weeks

Tesetaxel once weekly

Arm Description

Tesetaxel 27 mg/m2 orally once every 21 days for up to 12 months

Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks in a 28-day cycle for up to 12 months

Outcomes

Primary Outcome Measures

Response rate (revised RECIST)

Proportion of patients with a confirmed complete or partial response

Secondary Outcome Measures

Disease control rate

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

Progression-free rate

Proportion of patients without disease progression 6 months following the first dose of study medication

Durable response rate

Proportion of patients 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

Adverse events

Incidence of adverse events

Full Information

NCT ID

NCT01221870

First Posted

October 13, 2010

Last Updated

July 20, 2012

Sponsor

Genta Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01221870

Brief Title

Tesetaxel as First-line Therapy for Metastatic Breast Cancer

Official Title

A Phase II Study of Tesetaxel as First-line Therapy for Subjects With Metastatic Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Unknown status

Study Start Date

November 2010 (undefined)

Primary Completion Date

October 2012 (Anticipated)

Study Completion Date

January 2013 (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 taxane, paclitaxel, is one of the most commonly employed agents for the treatment of both localized and advanced breast cancer. Tesetaxel is an orally administered taxane that is in development as first- and second-line treatment for patients with advanced cancers. This study is being undertaken to determine the efficacy and safety of tesetaxel administered as first-line therapy to patients with metastatic breast cancer.

6. Conditions and Keywords

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

Breast Neoplasm

Keywords

Metastatic breast cancer, First-line therapy, Tesetaxel, Oral taxane

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tesetaxel once every 3 weeks

Arm Type

Experimental

Arm Description

Tesetaxel 27 mg/m2 orally once every 21 days for up to 12 months

Arm Title

Tesetaxel once weekly

Arm Type

Experimental

Arm Description

Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks in a 28-day cycle for up to 12 months

Intervention Type

Drug

Intervention Name(s)

Tesetaxel once every 3 weeks

Other Intervention Name(s)

DJ-927

Intervention Description

Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months

Intervention Type

Drug

Intervention Name(s)

Tesetaxel once weekly

Other Intervention Name(s)

DJ-927

Intervention Description

Tesetaxel capsules orally once every 7 days for 3 consecutive weeks in a 28-day cycle; duration of therapy not to exceed 12 months

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

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

Progression-free rate

Description

Proportion of patients without disease progression 6 months following the first dose of study medication

Time Frame

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

Title

Durable response rate

Description

Proportion of patients 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

Adverse events

Description

Incidence of adverse events

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Primary Inclusion Criteria: Female At least 18 years of age Histologically or cytologically confirmed adenocarcinoma of the breast Stage IV disease HER2 status negative Measurable disease (revised RECIST; Version 1.1) Eastern Cooperative Oncology Group performance status 0 or 1 Life expectancy of at least 3 months Chemotherapy naïve or 1 prior chemotherapy regimen in the adjuvant setting (Prior taxane-based adjuvant therapy allowed provided patient had a disease-free interval of at least 12 months after completing this adjuvant therapy) Prior hormonal therapy, aromatase inhibitor therapy, and immunotherapy allowed Prior radiotherapy in the adjuvant setting allowed provided that less than 25% of the bone marrow had been irradiated Adequate bone marrow, hepatic, and renal function, as specified in the protocol At least 4 weeks and recovery from effects of prior surgery, hormonal therapy, aromatase inhibitor therapy, immunotherapy, radiotherapy, or other therapy with an approved or investigational agent Ability to swallow an oral solid-dosage form of medication Primary Exclusion Criteria: Known metastasis to the central nervous system History of other malignancy within the last 5 years other than curatively treated basal and squamous cell carcinoma of the skin or carcinoma of the cervix in situ Significant medical disease other than Stage IV breast cancer Presence of neuropathy > Grade 1 (NCI CTC, Version 4.0) History of hypersensitivity to a taxane 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

Andrew D Seidman, 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

Andrew D Seidman, MD

Phone

646-888-4559

First Name & Middle Initial & Last Name & Degree

Andrew D Seidman, MD

Facility Name

The Moses H. Cone Regional Cancer Center

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27403

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter Rubin, MD

Phone

336-832-1100

First Name & Middle Initial & Last Name & Degree

Peter Rubin, MD

Facility Name

The West Clinic

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Texas Oncology - Baylor Charles A. Sammons Cancer Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joyce O'Shaughnessy, MD

joyce.oshaughnessy@usoncology.com

First Name & Middle Initial & Last Name & Degree

Joyce O'Shaughnessy, MD

12. IPD Sharing Statement

Learn more about this trial

Tesetaxel as First-line Therapy for Metastatic Breast Cancer

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