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Study Evaluating EKB-569 in Advanced Colorectal Cancer

2014-08-27 03:54:46 | BioPortfolio

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Conditions

Colorectal Neoplasms

Intervention

EKB-569

Status

Completed

Source

Wyeth

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:46-0400

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