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

This study is currently recruiting participants.
Verified July 2012 by Genta Incorporated
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT01296243
First received: February 10, 2011
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Tesetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Single-agent Tesetaxel in Chemotherapy-naive Patients Who Have Progressive, Castration-resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Genta Incorporated:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 6 months from the start of treatment ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 57
Study Start Date: February 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: DJ-927

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296243

Locations
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109-5946
Contact: Maha Hussain, MD, FACP    734-936-8906      
Principal Investigator: Maha Hussain, MD, FACP         
United States, New Jersey
The Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Tina Mayer, MD    732-235-8157      
Principal Investigator: Tina Mayer, MD         
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Michael J Morris, MD    646-422-4469    morrism@MSKCC.ORG   
Principal Investigator: Michael J Morris, MD         
United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53705
Contact: Justine Bruce, MD    608-262-4961      
Principal Investigator: Justine Y Bruce, MD         
Sponsors and Collaborators
Genta Incorporated
Investigators
Principal Investigator: Michael J Morris, MD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT01296243     History of Changes
Other Study ID Numbers: TOP205, PCCTC LOI # c10-071
Study First Received: February 10, 2011
Last Updated: July 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Genta Incorporated:
Castration-resistant prostate cancer
Tesetaxel
Taxanes
Chemotherapy-naive
Chemotherapy-exposed
Progressive, metastatic castration-resistant prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014