Status:
UNKNOWN
Tesetaxel as First-line Therapy for Metastatic Breast Cancer
Lead Sponsor:
Genta Incorporated
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 taxa...
Eligibility Criteria
Inclusion
- Primary
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01221870
Start Date
November 1 2010
End Date
January 1 2013
Last Update
July 24 2012
Active Locations (4)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
2
The Moses H. Cone Regional Cancer Center
Greensboro, North Carolina, United States, 27403
3
The West Clinic
Memphis, Tennessee, United States, 38120
4
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246