NCT00072748

Brief Summary

This non-randomized, open-label, outpatient clinical trial is designed to assess the safety and efficacy of daily orally administered EKB-569 in subjects with advanced colorectal cancer. Patients must have been previously treated with a fluoropyrimidine (5-FU or capecitabine) and either oxaliplatin or irinotecan (given concurrently or as separate regimens). The primary objective of the study is to assess the clinical activity of EKB-569 administered orally as a second-line or later stage treatment in subjects with advanced colorectal cancer. Secondary objectives include:

  • To further evaluate the safety of EKB-569
  • To explore additional clinical activity parameters
  • To explore subject survival
  • To evaluate the pharmacokinetics of EKB-569
  • To assess subject reported outcomes EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569 daily as long as they do not have progressive disease and are tolerating treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

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

First Submitted

Initial submission to the registry

November 10, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

August 21, 2009

Status Verified

August 1, 2009

First QC Date

November 10, 2003

Last Update Submit

August 20, 2009

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Keywords

Advanced Colorectal CancerColorectal CarcinomaColorectal TumorsNeoplasms, Colorectal

Interventions

EKB-569DRUG

Eligibility Criteria

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

You may qualify if:

  • Signed and dated, institutional review board (IRB) or independent ethics committee (IEC)-approved informed consent form before any protocol-specific screening procedures
  • Previous histologic diagnosis of adenocarcinoma of the colon or rectum
  • EGFR expression by immunohistochemical analysis (must be \> or = 20% positive tumor cells in prior tumor biopsy specimens)

You may not qualify if:

  • Chemotherapy, radiotherapy, anticancer immunotherapy, or investigational agents within 4 weeks of treatment day 1 (6 weeks if the previous regimen included mitomycin or nitrosoureas).
  • Prior epidermal growth factor receptor-targeting therapy
  • Known central nervous system (CNS) metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

EKB 569

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 10, 2003

First Posted

November 13, 2003

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

August 21, 2009

Record last verified: 2009-08