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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tesetaxel
Sponsored by
Genta Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Castration-resistant prostate cancer, Tesetaxel, Taxanes, Chemotherapy-naive, Chemotherapy-exposed, Progressive, metastatic castration-resistant prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Health SystemRecruiting
  • The Cancer Institute of New JerseyRecruiting
  • Memorial Sloan-Kettering Cancer CenterRecruiting
  • University of Wisconsin Carbone Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tesetaxel once every 3 weeks

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Response rate (RECIST 1.1) among patients with measurable disease
Duration of response among patients with measurable disease
Durable response among patients with measurable disease
Overall survival
Disease-control rate
PSA response rate
Progression-free survival
No. (percentage) of subjects with adverse events

Full Information

First Posted
February 10, 2011
Last Updated
July 20, 2012
Sponsor
Genta Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01296243
Brief Title
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genta Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Castration-resistant prostate cancer, Tesetaxel, Taxanes, Chemotherapy-naive, Chemotherapy-exposed, Progressive, metastatic castration-resistant prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tesetaxel once every 3 weeks
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tesetaxel
Other Intervention Name(s)
DJ-927
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
6 months from the start of treatment
Secondary Outcome Measure Information:
Title
Response rate (RECIST 1.1) among patients with measurable disease
Time Frame
6 months from the start of treatment
Title
Duration of response among patients with measurable disease
Time Frame
12 months from the start of treatment
Title
Durable response among patients with measurable disease
Time Frame
12 months from the start of treatment
Title
Overall survival
Time Frame
3 years following enrollment of the last subject
Title
Disease-control rate
Time Frame
6 months from the start of treatment
Title
PSA response rate
Time Frame
Week 12
Title
Progression-free survival
Time Frame
12 months from the start of treatment
Title
No. (percentage) of subjects with adverse events
Time Frame
Through 30 days after the last dose of tesetaxel

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Morris, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5946
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maha Hussain, MD, FACP
Phone
734-936-8906
First Name & Middle Initial & Last Name & Degree
Maha Hussain, MD, FACP
Facility Name
The Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Mayer, MD
Phone
732-235-8157
First Name & Middle Initial & Last Name & Degree
Tina Mayer, MD
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael J Morris, MD
Phone
646-422-4469
Email
morrism@MSKCC.ORG
First Name & Middle Initial & Last Name & Degree
Michael J Morris, MD
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justine Bruce, MD
Phone
608-262-4961
First Name & Middle Initial & Last Name & Degree
Justine Y Bruce, MD

12. IPD Sharing Statement

Learn more about this trial

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

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