Vorinostat and Palliative Radiotherapy (PRAVO)

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00455351
First received: April 2, 2007
Last updated: July 21, 2011
Last verified: July 2011

April 2, 2007
July 21, 2011
February 2007
Not Provided
DLT [ Time Frame: continously ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00455351 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2009
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00455351
EudraCTnumber 2006-003631-76
No
Svein Dueland (PI), Rikshospitalet-Radiumhospitalet HF
Oslo University Hospital
Not Provided
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