Tesetaxel as First-line Therapy for Metastatic Breast Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Neoplasm
• Intervention / Treatment: Drug: Tesetaxel once every 3 weeks; Drug: Tesetaxel once weekly

• Study Type: Interventional
• Enrollment (Anticipated): 81
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: DJ-927

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Adverse events	Incidence of adverse events	Up to 30 days after the last dose of study medication for a specific patient

Collaborators and Investigators

• Sponsor: Genta Incorporated

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): October 1, 2012
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: October 13, 2010
• First Submitted That Met QC Criteria: October 14, 2010
• First Posted (Estimate): October 15, 2010

Study Record Updates

• Last Update Posted (Estimate): July 24, 2012
• Last Update Submitted That Met QC Criteria: July 20, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Metastatic breast cancer; First-line therapy; Tesetaxel; Oral taxane
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: TOB203