Tesetaxel as First-line Therapy for Metastatic Breast Cancer
NCT ID: NCT01221870
Last Updated: 2012-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
81 participants
INTERVENTIONAL
2010-11-30
2013-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tesetaxel once every 3 weeks
Tesetaxel 27 mg/m2 orally once every 21 days for up to 12 months
Tesetaxel once every 3 weeks
Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months
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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Genta Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew D Seidman, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
The Moses H. Cone Regional Cancer Center
Greensboro, North Carolina, United States
The West Clinic
Memphis, Tennessee, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Countries
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Facility Contacts
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Andrew D Seidman, MD
Role: primary
Peter Rubin, MD
Role: primary
Joyce O'Shaughnessy, MD
Role: primary
Other Identifiers
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TOB203
Identifier Type: -
Identifier Source: org_study_id