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Completed

NCT Number: NCT00328458

EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients

The purpose of this study is to determine the safety of the drug EPO906 that could shrink tumors when used with radiation therapy in cancer patients.

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Key information

Conditions

Central Nervous System Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

  • To determine the maximum tolerated dose (MTD) of EPO906 administered in combination with radiation therapy and establish a recommend phase II dose.
  • To evaluate the safety and toxicity profile of EPO906 when administered concurrently with radiotherapy in three disease cohorts.
  • To evaluate tumor response.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Requires a minimum of 3 weeks of radiation therapy
  • Solid tumors with advanced or recurrent disease for which there is no standard therapy or tumors have failed standard therapy
  • World Health Organization (WHO) performance status equal to or less than 2
  • Life expectancy equal to or greater than 3 months

Exclusion criteria

  • Any peripheral neuropathy
  • Unresolved diarrhea greater than grade 1
  • Patients who received any other investigational compound within the past 28 days
  • Severe cardiac insufficiency
  • Patients on Coumadin

Treatment and study plan

EPO906 (epothilone B)

Drug

Primary outcomes

  1. Maximum tolerated dose (MTD) of EPO906

    Time frame: Baseline to 7 weeks

Secondary outcomes

  1. Number of participants that successful complete 7 weekly cycles of EPO906 concurrently with radiotherapy

    Time frame: Baseline to 7 weeks

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study title

A Phase I, Open-label, Dose-escalation, Safety Study of the Combination of EPO906 and Radiation Therapy for the Treatment of Patients With Cancer

Important dates

Study start
2004
Primary completion
2008
Study completion
2009
First posted
May 22, 2006
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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