Vorinostat and Palliative Radiotherapy (PRAVO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00455351
Recruitment Status : Completed
First Posted : April 3, 2007
Last Update Posted : July 22, 2011
Information provided by:
Oslo University Hospital

April 2, 2007
April 3, 2007
July 22, 2011
February 2007
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DLT [ Time Frame: continously ]
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Complete list of historical versions of study NCT00455351 on Archive Site
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Vorinostat and Palliative Radiotherapy
Phase I Study on Suberoylanilide Hydroxyamic Acid (Vorinostat) a Histone Deacetylase Inhibitor, in Palliative Radiotherapy for Advanced Tumors.
Phase I study. Side-effects when combined with standard palliative radiotherapy.
Not Provided
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pelvic Cancer
  • Radiotherapy
Drug: Vorinostat
Increasing dosing, phase I
Experimental: A I
Study drug
Intervention: Drug: Vorinostat

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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August 2009
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
EudraCTnumber 2006-003631-76
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Svein Dueland (PI), Rikshospitalet-Radiumhospitalet HF
Oslo University Hospital
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Study Director: Sigbjørn Smeland, MD,PhD Norwegian Radium Hospital
Oslo University Hospital
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP