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Study of CEP-701 in Treatment of Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 )

Tracking Information
First Submitted Date  ICMJE April 15, 2004
First Posted Date  ICMJE April 19, 2004
Last Update Posted Date August 24, 2012
Study Start Date  ICMJE March 2004
Actual Primary Completion Date May 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00081601 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of CEP-701 in Treatment of Prostate Cancer
Official Title  ICMJE An Open-Label Phase 2 Study of Oral CEP-701 in Patients With Asymptomatic Hormone-Refractory Cancer With Rising Prostate Specific Antigen
Brief Summary The purpose of this study is to determine the proportion of patients with a serological prostate specific antigen (PSA) by day 85.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: CEP-701
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
30
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2005
Actual Primary Completion Date May 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00081601
Other Study ID Numbers  ICMJE C0701a/203/ON/US
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries ( Cephalon )
Study Sponsor  ICMJE Cephalon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Teva Pharmaceutical Industries
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP