Tesetaxel as First-line Therapy for Metastatic Breast Cancer

Breast Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01221870
• Other study ID #: TOB203
• Status: Recruiting
• Phase: Phase 2
• First received: October 13, 2010
• Last updated: July 20, 2012
• Start date: November 2010
• Est. completion date: January 2013

Study information

• Verified date: July 2012
• Source: Genta Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: January 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Drug:
• Tesetaxel once every 3 weeks
Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months
• 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

Locations

Country	Name	City	State
United States	Texas Oncology - Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	The Moses H. Cone Regional Cancer Center	Greensboro	North Carolina
United States	The West Clinic	Memphis	Tennessee
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (revised RECIST)	Proportion of patients with a confirmed complete or partial response	12 months from date of first dose of study medication for last patient enrolled	No
Secondary	Disease control rate	Proportion of patients with a confirmed complete or partial response of any duration or stable disease = 3 months in duration	12 months from date of first dose of study medication for last patient enrolled	No
Secondary	Progression-free rate	Proportion of patients without disease progression 6 months following the first dose of study medication	6 months from date of first dose of study medication for last patient enrolled	No
Secondary	Durable response rate	Proportion of patients with a confirmed complete or partial response = 6 months in duration	12 months from date of first dose of study medication for last patient enrolled	No
Secondary	Duration of response	Date when response criteria are first met to the date when progression is first documented	12 months from date of first dose of study medication for last patient enrolled	No
Secondary	Time to progression	Date of first dose of study medication to the date when progression is first documented	12 months from date of first dose of study medication for last patient enrolled	No
Secondary	Adverse events	Incidence of adverse events	Up to 30 days after the last dose of study medication for a specific patient	Yes