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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Study of Single-agent Tesetaxel in Chemotherapy-naive Patients Who Have Progressive, Castration-resistant Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Tesetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tesetaxel once every 3 weeks<br> | Drug: Tesetaxel<br>* Tesetaxel capsules will be administered orally once every 21 days until progression, as defined by Prostate Cancer Working Group 2 (PCWG2) criteria. The duration of protocol therapy will not exceed 12 months. Treatment will be initiated at a dose of 27 mg/m2; dose escalation to a maximum of 35 mg/m2 is allowed in Cycle 2 depending on tolerability.<br>* Other names: DJ-927;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 6 months from the start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (RECIST 1.1) among patients with measurable disease |  | 6 months from the start of treatment | 
| Duration of response among patients with measurable disease |  | 12 months from the start of treatment | 
| Durable response among patients with measurable disease |  | 12 months from the start of treatment | 
| Overall survival |  | 3 years following enrollment of the last subject | 
| Disease-control rate |  | 6 months from the start of treatment | 
| PSA response rate |  | Week 12 | 
| Progression-free survival |  | 12 months from the start of treatment | 
| No. (percentage) of subjects with adverse events |  | Through 30 days after the last dose of tesetaxel | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Castration-resistant prostate cancer, Tesetaxel, Taxanes, Chemotherapy-naive, Chemotherapy-exposed, Progressive, metastatic castration-resistant prostate cancer