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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.
 
ClinicalTrials.gov Identifier: NCT00455351
Recruitment Status : Completed
First Posted : April 3, 2007
Last Update Posted : July 22, 2011
Sponsor:
Information provided by:
Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE April 2, 2007
First Posted Date  ICMJE April 3, 2007
Last Update Posted Date July 22, 2011
Study Start Date  ICMJE February 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2008)
DLT [ Time Frame: continously ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vorinostat and Palliative Radiotherapy
Official Title  ICMJE Phase I Study on Suberoylanilide Hydroxyamic Acid (Vorinostat) a Histone Deacetylase Inhibitor, in Palliative Radiotherapy for Advanced Tumors.
Brief Summary Phase I study. Side-effects when combined with standard palliative radiotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pelvic Cancer
  • Radiotherapy
Intervention  ICMJE Drug: Vorinostat
Increasing dosing, phase I
Study Arms  ICMJE Experimental: A I
Study drug
Intervention: Drug: Vorinostat
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 21, 2008)
20
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00455351
Other Study ID Numbers  ICMJE EudraCTnumber 2006-003631-76
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Svein Dueland (PI), Rikshospitalet-Radiumhospitalet HF
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sigbjørn Smeland, MD,PhD Norwegian Radium Hospital
PRS Account Oslo University Hospital
Verification Date July 2011

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