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


Phase 1
18 Years
N/A
Not Enrolling
Both
Central Nervous System Neoplasms, Head and Neck Neoplasms

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Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of EPO906 when administered to the following patient cohorts who receive 3-7 weeks of radiotherapy

Principal Investigator

Adam Dicker, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University

Authority:

United States: Food and Drug Administration

Study ID:

03C.275

NCT ID:

NCT00328458

Start Date:

February 2004

Completion Date:

July 2009

Related Keywords:

  • Central Nervous System Neoplasms
  • Head and Neck Neoplasms
  • CNS and head and neck cancers
  • Histologically confirmed CNS malignancy head and neck
  • there is on standard therapy or
  • have failed standard therapy
  • Neoplasms
  • Head and Neck Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Thomas Jefferson University HospitalPhiladelphia, Pennsylvania  19131