Phase I Study on Suberoylanilide Hydroxyamic Acid (Vorinostat) a Histone Deacetylase Inhibitor, in Palliative Radiotherapy for Advanced Tumors.
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Pelvic Cancer, Radiotherapy
Both
Pelvic Cancer, Radiotherapy
Trial Information
Phase I Study on Suberoylanilide Hydroxyamic Acid (Vorinostat) a Histone Deacetylase Inhibitor, in Palliative Radiotherapy for Advanced Tumors.
Inclusion Criteria:
- Pelvic malignancy
- Palliative radiation treatment planed
- ECOG <3
- Age>18 years
Exclusion Criteria:
- Previous pelvic radiotherapy
- Uncontrolled diarrhea
- Insulin-dependent diabetes mellitus
- BMI<18.5
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:
DLT
Outcome Time Frame:
continously
Safety Issue:
Yes
Principal Investigator
Sigbjørn Smeland, MD,PhD
Investigator Role:
Study Director
Investigator Affiliation:
Norwegian Radium Hospital
Authority:
Norway: Norwegian Medicines Agency
Study ID:
EudraCTnumber 2006-003631-76
NCT ID:
NCT00455351
Start Date:
February 2007
Completion Date:
August 2009
Related Keywords:
- Pelvic Cancer
- Radiotherapy
- Palliative treatment
- Max. tolerable dose
- Pelvic Neoplasms
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