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Study of CEP-701 in Treatment of Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00081601
Recruitment Status : Completed
First Posted : April 19, 2004
Last Update Posted : August 24, 2012
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )

Brief Summary:
The purpose of this study is to determine the proportion of patients with a serological prostate specific antigen (PSA) by day 85.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: CEP-701 Phase 2

Detailed Description:
A serological PSA response is defined as a reduction from baseline PSA serum concentration of at least 50%, which is confirmed by a second PSA value 28 or more days later.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase 2 Study of Oral CEP-701 in Patients With Asymptomatic Hormone-Refractory Cancer With Rising Prostate Specific Antigen
Study Start Date : March 2004
Actual Primary Completion Date : May 2005
Actual Study Completion Date : June 2005

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • at least 18 yrs of age
  • diagnosis of adenocarcinoma of the prostate
  • no detectable metastatic disease as assessed by bone and CT scans
  • has increasing serum PSA concentrations
  • life expectancy of at least 3 months
  • ECOG of 0 or 1
  • has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period

Exclusion Criteria:

  • has asymptomatic disease
  • has active GI ulceration or bleeding
  • has been treated with non-hormonal systemic anticancer therapy or has received radiation within 4 weeks of baseline visit
  • bilirubin >2x ULN or ALT or AST >2xULN or serum creatinine >1.5mg/dL
  • hemoglobin <9g/dL or platelets below 100,000/uL or ANC below 1500/uL
  • receiving treatment for HIV with protease inhibitors
  • has had prior malignancy within past 5 yrs with exception of resected basal or squamous cell carcinomas of the skin
  • has used investigational drug with previous one month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00081601


Locations
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United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Cephalon

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Responsible Party: Cephalon
ClinicalTrials.gov Identifier: NCT00081601     History of Changes
Other Study ID Numbers: C0701a/203/ON/US
First Posted: April 19, 2004    Key Record Dates
Last Update Posted: August 24, 2012
Last Verified: August 2012

Keywords provided by Teva Pharmaceutical Industries ( Cephalon ):
prostate cancer
prostate specific antigen
PSA

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