Tesetaxel in Chemotherapy-naive Patients With Progressive, Castration-resistant Prostate Cancer

• Status: Unknown status
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genta Incorporated

Criteria

Key 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