Study Evaluating EKB-569 in Advanced Colorectal Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00072748

Enrollment

Registered

2003-11-13

Start date

Unknown

Completion date

2004-10-31

Last updated

2009-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Neoplasms, Colorectal Neoplasms, Rectal Neoplasms

Keywords

Advanced Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal

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.

Interventions

DRUGEKB-569

Study design

Allocation

NON_RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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)

Exclusion criteria

* 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026