Prostate Cancer
Conditions
Keywords
Castration-resistant prostate cancer, Tesetaxel, Taxanes, Chemotherapy-naive, Chemotherapy-exposed, Progressive, metastatic castration-resistant prostate cancer
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.
Interventions
DRUGTesetaxel
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.
Sponsors
Genta Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | 6 months from the start of treatment |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed