Tesetaxel in Chemotherapy-naive Patients With Progressive, Castration-resistant Prostate Cancer
Trial Status: Active
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.
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
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
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE
New Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: CLOSED_TO_ACCRUAL
New York
New York
Memorial Sloan Kettering Cancer Center
Status: COMPLETED
Wisconsin
Madison
University of Wisconsin Carbone Cancer Center
Status: COMPLETED
Trial Phase Phase II
Trial Type Treatment
Lead Organization
Genta Inc
- Primary ID TOP205
- Secondary IDs NCI-2012-00357, PCCTC LOI # c10-071
- Clinicaltrials.gov ID NCT01296243