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

July 20, 2012 updated by: Genta Incorporated

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5946
        • Recruiting
        • University of Michigan Health System
        • Contact:
          • Maha Hussain, MD, FACP
          • Phone Number: 734-936-8906
        • Principal Investigator:
          • Maha Hussain, MD, FACP
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • The Cancer Institute of New Jersey
        • Contact:
          • Tina Mayer, MD
          • Phone Number: 732-235-8157
        • Principal Investigator:
          • Tina Mayer, MD
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan-Kettering Cancer Center
        • Principal Investigator:
          • Michael J Morris, MD
        • Contact:
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University of Wisconsin Carbone Cancer Center
        • Contact:
          • Justine Bruce, MD
          • Phone Number: 608-262-4961

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tesetaxel once every 3 weeks
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.
Other Names:
  • DJ-927

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genta Incorporated

Investigators

  • Principal Investigator: Michael J Morris, MD, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

February 10, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (Estimate)

February 15, 2011

Study Record Updates

Last Update Posted (Estimate)

July 24, 2012

Last Update Submitted That Met QC Criteria

July 20, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOP205
  • PCCTC LOI # c10-071 (Other Identifier: Prostate Cancer Clinical Trials Consortium)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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