Tesetaxel as First-line Therapy for Metastatic Breast Cancer

NCT01221870 | Unknown Phase 2

• 1 other identifier: TOB203
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Disease control rate

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

• Progression-free rate

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

• Durable response rate

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

• Duration of response

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

• Time to progression

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

Study Arms (2)

Tesetaxel once every 3 weeks

EXPERIMENTAL

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

Drug: Tesetaxel once every 3 weeks

Tesetaxel once weekly

EXPERIMENTAL

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

Interventions

Tesetaxel once every 3 weeks DRUG

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

Also known as: DJ-927

Tesetaxel once every 3 weeks

Tesetaxel once weekly DRUG

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

Also known as: DJ-927

Tesetaxel once weekly

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genta Incorporated: lead

Study Sites (4)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

The Moses H. Cone Regional Cancer Center

Greensboro, North Carolina, 27403, United States

RECRUITING

The West Clinic

Memphis, Tennessee, 38120, United States

ACTIVE NOT RECRUITING

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

tesetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andrew D Seidman, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: October 15, 2010
• Study Start: November 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2013
• Last Updated: July 24, 2012

Record last verified: 2012-07

Locations

US (4)