Head and Neck Neoplasms Clinical Trial
Official 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
Verified date | July 2018 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | July 2009 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Cancer Center at Thomas Jefferson University | Novartis Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose (MTD) of EPO906 | Baseline to 7 weeks | ||
Secondary | Number of participants that successful complete 7 weekly cycles of EPO906 concurrently with radiotherapy | Baseline to 7 weeks |
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