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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01296243
• Other study ID #: TOP205
• Secondary ID: PCCTC LOI # c10-
• Status: Recruiting
• Phase: Phase 2
• First received: February 10, 2011
• Last updated: July 20, 2012
• Start date: February 2011
• Est. completion date: February 2015

Study information

• Verified date: July 2012
• Source: Genta Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: February 2015
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Tesetaxel
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.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin
United States	The Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated

Country where clinical trial is conducted

United States, 

Outcome

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