Clinical trial NCT01296243: Tesetaxel in Chemotherapy-naive Patients With Progressive, Castration-resistant Prostate Cancer
Official title: A Phase II Study of Single-agent Tesetaxel in Chemotherapy-naive Patients Who Have Progressive, Castration-resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Castration-resistant prostate cancer
Tesetaxel
Taxanes
Chemotherapy-naive
Chemotherapy-exposed
Progressive, metastatic castration-resistant prostate cancer
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2011-02-15
Enrollment: 57
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 6 months from the start of treatment
Secondary outcomes:
measure: Response rate (RECIST 1.1) among patients with measurable disease
timeFrame: 6 months from the start of treatment
measure: Duration of response among patients with measurable disease
timeFrame: 12 months from the start of treatment
measure: Durable response among patients with measurable disease
timeFrame: 12 months from the start of treatment
measure: Overall survival
timeFrame: 3 years following enrollment of the last subject
measure: Disease-control rate
timeFrame: 6 months from the start of treatment
measure: PSA response rate
timeFrame: Week 12
measure: Progression-free survival
timeFrame: 12 months from the start of treatment
measure: No. (percentage) of subjects with adverse events
timeFrame: Through 30 days after the last dose of tesetaxel
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: New Brunswick
country: United States
facility: The Cancer Institute of New Jersey
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michael J Morris, MD
role: PRINCIPAL_INVESTIGATOR
References: