Clinical trial NCT01221870: Tesetaxel as First-line Therapy for Metastatic Breast Cancer
Official title: A Phase II Study of Tesetaxel as First-line Therapy for Subjects With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Neoplasm
Keywords: Metastatic breast cancer
First-line therapy
Tesetaxel
Oral taxane
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2010-10-15
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Response rate (revised RECIST)
timeFrame: 12 months from date of first dose of study medication for last patient enrolled
Secondary outcomes:
measure: Disease control rate
timeFrame: 12 months from date of first dose of study medication for last patient enrolled
measure: Progression-free rate
timeFrame: 6 months from date of first dose of study medication for last patient enrolled
measure: Durable response rate
timeFrame: 12 months from date of first dose of study medication for last patient enrolled
measure: Duration of response
timeFrame: 12 months from date of first dose of study medication for last patient enrolled
measure: Time to progression
timeFrame: 12 months from date of first dose of study medication for last patient enrolled
measure: Adverse events
timeFrame: Up to 30 days after the last dose of study medication for a specific patient
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Greensboro
country: United States
facility: The Moses H. Cone Regional Cancer Center
state: North Carolina
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrew D Seidman, MD
role: PRINCIPAL_INVESTIGATOR
References: