NCT00065572

Brief Summary

The purpose of this study is to assess the biological activity of ZD6126 in subjects with newly diagnosed metastatic renal cell carcinoma (stage IV).

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Timeline
Completed

Started Aug 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

16 active sites

Status
suspended

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

First Submitted

Initial submission to the registry

July 28, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2003

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2003

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

January 26, 2011

Status Verified

January 1, 2011

Enrollment Period

6 months

First QC Date

July 28, 2003

Last Update Submit

January 25, 2011

Conditions

Keywords

Kidney CancerMetastaticNewly diagnosed renal cell carcinoma

Interventions

Eligibility Criteria

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

You may qualify if:

  • Newly diagnosed metastatic renal cell carcinoma
  • Suitable for nephrectomy

You may not qualify if:

  • Prior chemotherapy, biological therapy or radiation therapy for renal cell carcinoma or within the last 3 years for any other cancer
  • Significant cardiac event within 3 months of entry
  • Any history of coronary angioplasty or history of myocardial infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Research Site

Los Angeles, California, United States

Location

Research Site

Newark, Delaware, United States

Location

Research Site

Tampa, Florida, United States

Location

Research Site

Chicago, Illinois, United States

Location

Research Site

Indianapolis, Indiana, United States

Location

Research Site

Baltimore, Maryland, United States

Location

Research Site

St Louis, Missouri, United States

Location

Research Site

Lebanon, New Hampshire, United States

Location

Research Site

Hackensack, New Jersey, United States

Location

Research Site

Rochester, New York, United States

Location

Research Site

The Bronx, New York, United States

Location

Research Site

Cleveland, Ohio, United States

Location

Research Site

Portland, Oregon, United States

Location

Research Site

Philadelphia, Pennsylvania, United States

Location

Research Site

Nashville, Tennessee, United States

Location

Research Site

Salt Lake City, Utah, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal CellKidney NeoplasmsNeoplasm Metastasis

Interventions

N-acetylcochinol-O-phosphate

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 28, 2003

First Posted

July 31, 2003

Study Start

August 1, 2003

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

January 26, 2011

Record last verified: 2011-01

Locations