Tesetaxel as First-line Therapy for Metastatic Breast Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Breast Neoplasm	Drug: Tesetaxel once every 3 weeks Drug: Tesetaxel once weekly	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Tesetaxel as First-line Therapy for Subjects With Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast 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:

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
Progression-free rate [ Time Frame: 6 months from date of first dose of study medication for last patient enrolled ] [ Designated as safety issue: No ]
Proportion of patients without disease progression 6 months following the first dose of study medication
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 patients 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
Adverse events [ Time Frame: Up to 30 days after the last dose of study medication for a specific patient ] [ Designated as safety issue: Yes ]
Incidence of adverse events

Estimated Enrollment:	81
Study Start Date:	November 2010
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tesetaxel once every 3 weeks Tesetaxel 27 mg/m2 orally once every 21 days for up to 12 months	Drug: Tesetaxel once every 3 weeks Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months Other Name: DJ-927
Experimental: Tesetaxel once weekly Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks in a 28-day cycle for up to 12 months	Drug: Tesetaxel once weekly Tesetaxel capsules orally once every 7 days for 3 consecutive weeks in a 28-day cycle; duration of therapy not to exceed 12 months Other Name: DJ-927

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221870

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Andrew D Seidman, MD 646-888-4559
Principal Investigator: Andrew D Seidman, MD
United States, North Carolina
The Moses H. Cone Regional Cancer Center	Recruiting
Greensboro, North Carolina, United States, 27403
Contact: Peter Rubin, MD 336-832-1100
Principal Investigator: Peter Rubin, MD
United States, Tennessee
The West Clinic	Active, not recruiting
Memphis, Tennessee, United States, 38120
United States, Texas
Texas Oncology - Baylor Charles A. Sammons Cancer Center	Recruiting
Dallas, Texas, United States, 75246
Contact: Joyce O'Shaughnessy, MD joyce.oshaughnessy@usoncology.com
Principal Investigator: Joyce O'Shaughnessy, MD

Sponsors and Collaborators

Genta Incorporated

Investigators

Principal Investigator:

Andrew D Seidman, MD

Memorial Sloan-Kettering Cancer Center

More Information

No publications provided

Responsible Party:	Genta Incorporated
ClinicalTrials.gov Identifier:	NCT01221870 History of Changes
Other Study ID Numbers:	TOB203
Study First Received:	October 13, 2010
Last Updated:	July 20, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genta Incorporated:

Metastatic breast cancer
First-line therapy
Tesetaxel
Oral taxane

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013