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

Genta Incorporated

Status and phase: Unknown; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Tesetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01296243

TOP205

PCCTC LOI # c10-071 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 57 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Tesetaxel once every 3 weeks

Experimental group

Treatment:

Drug: Tesetaxel