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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.


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- has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering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

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

C0701a/203/ON/US

NCT ID:

NCT00081601

Start Date:

March 2004

Completion Date:

June 2005

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • prostate specific antigen
  • PSA
  • Prostatic Neoplasms

Name

Location

Johns HopkinsBaltimore, Maryland  21231