Study of CEP-701 in Treatment of Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

An Open-Label Phase 2 Study of Oral CEP-701 in Patients With Asymptomatic Hormone-Refractory Cancer With Rising Prostate Specific Antigen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00081601
• Other study ID #: C0701a/203/ON/US
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2004
• Last updated: August 22, 2012
• Start date: March 2004
• Est. completion date: June 2005

Study information

• Verified date: August 2012
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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• has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• CEP-701

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Country where clinical trial is conducted

United States,