EPO906 Therapy in Patients With Prostate Cancer

February 7, 2017 updated by: Novartis Pharmaceuticals

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Androgen-independent Prostate Cancer

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

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
    • California
      • Long Beach, California, United States, 90813
        • Pacific Shores Medical Group
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland - Greenbaum Cancer Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Cancer Institute of New Jersey (CINJ)
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

The following patients may be eligible for this study:

  • Patients with any histologically proven prostate cancer with measurable metastatic disease or PSA progression > 20ng/ml after initial hormonal therapy will be eligible
  • Patients must be maintained on androgen ablation therapy with a LHRH agonist or have undergone orchiectomy
  • Patients in whom bicalutamide or flutamide has been recently withdrawn must demonstrate progression of disease and be at least 6 weeks and 4 weeks respectively, beyond the discontinuation of such agents
  • Patients taking PC-SPES must discontinue therapy for a minimum of 4 weeks
  • For patients with disease progression defined solely by PSA increase: two consecutive rises in PSA measurement, over a 4-week period (each separated from the previous by 2 weeks) - the last measurement must be at least 50% greater than the nadir PSA achieved after the last therapeutic maneuver
  • For patients who discontinued bicalutamide therapy prior to study entry, a third rising PSA measurement is required 2 weeks from the second PSA measurement (i.e. over a 6 week period)
  • Must have a life expectancy of greater than three (3) months
  • Bilirubin must be within normal limits. Transaminases (SGOT and/or SGPT) may be up to 2.5 X institutional upper limit of normal if alkaline phosphatase is less than the upper limit of normal, or alkaline phosphatase may be up to 4 X upper limit of normal if transaminases are less than or equal to the upper limit of normal
  • For patients with disease progression defined by measurable disease: changes in measurable size of lymph nodes or parenchymal masses on physical or radiologic examination (bone scan findings are not adequate to assess measurable disease).

Exclusion Criteria:

The following patients are not eligible for the study:

  • Patients with symptomatic CNS metastases or leptomeningeal involvement
  • Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
  • Patients with severe cardiac insufficiency
  • Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
  • Patients who received palliative radiotherapy to tumors located centrally less than 4 weeks (28 days) prior to planned enrollment date (palliative radiotherapy to isolated peripheral bone metastases is allowed)
  • Patients experiencing hormone withdrawal syndrome, or are 28 days post-withdrawal of anti-androgen therapy (42 days for bicalutamide)
  • Patients who have had more than one prior chemotherapy regimen for hormone-resistant metastatic disease
  • Patients with disease measurable only by bone scan
  • Patients who have received corticosteroids within the past 28 days (may be waived with approval from Novartis)
  • History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer
  • Patients who have undergone major surgery for any cause less than 4 weeks prior to study entry
  • Patients with radiation therapy or chemotherapy within the last four weeks
  • Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
  • HIV+ patients

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)

Secondary Outcome Measures

Outcome Measure
Time to progression
Overall survival

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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

January 1, 2002

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

May 2, 2002

First Submitted That Met QC Criteria

May 2, 2002

First Posted (Estimate)

May 3, 2002

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEPO906A2204

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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