NCT00081601

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

August 24, 2012

Status Verified

August 1, 2012

Enrollment Period

1.2 years

First QC Date

April 15, 2004

Last Update Submit

August 22, 2012

Conditions

Prostate Cancer

Keywords

prostate cancerprostate specific antigenPSA

Interventions

CEP-701DRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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  • has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

lestaurtinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2004

First Posted

April 19, 2004

Study Start

March 1, 2004

Primary Completion

May 1, 2005

Study Completion

June 1, 2005

Last Updated

August 24, 2012

Record last verified: 2012-08

Locations

US(1)