Tesetaxel in Chemotherapy-naive Patients With Progressive, Castration-resistant Prostate Cancer
- Registration Number
- NCT01296243
- Lead Sponsor
- Genta Incorporated
- Brief Summary
Given the activity of docetaxel in patients with progressive, metastatic castration-resistant prostate cancer, this study is being undertaken to evaluate the activity of tesetaxel, an orally bioavailable taxane, in chemotherapy-naive and chemotherapy-exposed patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 57
Inclusion Criteria
- At least 18 years of age
- Histologically confirmed prostate cancer, currently with progressive disease
- Evidence of metastatic disease
- Castrate level of testosterone (< 50 ng/dL)
- Eastern Cooperative Oncology Group performance status 0 or 1
- Chemotherapy-naïve
- Adequate bone marrow, hepatic, and renal function
- Ability to swallow an oral solid-dosage form of medication
Key
Exclusion Criteria
- History or presence of brain metastasis or leptomeningeal disease
- Operable cancer
- Uncontrolled diarrhea
- Uncontrolled nausea or vomiting
- Known malabsorptive disorder
- Currently active second malignancy other than non-melanoma skin cancers
- Human immunodeficiency virus (HIV) infection based on history of positive serology
- Significant medical disease other than cancer
- Presence of neuropathy > Grade 2 (National Cancer Institute Common Toxicity Criteria [NCI CTC]; v4.0)
- Need for other anticancer treatment
- Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
- Less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
- Less than 4 weeks since use of another investigational agent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tesetaxel once every 3 weeks Tesetaxel -
- Primary Outcome Measures
Name Time Method Progression-free survival 6 months from the start of treatment
- Secondary Outcome Measures
Name Time Method Response rate (RECIST 1.1) among patients with measurable disease 6 months from the start of treatment No. (percentage) of subjects with adverse events Through 30 days after the last dose of tesetaxel Duration of response among patients with measurable disease 12 months from the start of treatment Progression-free survival 12 months from the start of treatment Disease-control rate 6 months from the start of treatment Overall survival 3 years following enrollment of the last subject Durable response among patients with measurable disease 12 months from the start of treatment PSA response rate Week 12
Trial Locations
- Locations (4)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
The Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
University of Wisconsin Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States