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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014