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Vorinostat and Palliative Radiotherapy (PRAVO)

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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

Brief Summary:
Phase I study. Side-effects when combined with standard palliative radiotherapy.

Condition or disease Intervention/treatment Phase
Pelvic Cancer Radiotherapy Drug: Vorinostat Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study on Suberoylanilide Hydroxyamic Acid (Vorinostat) a Histone Deacetylase Inhibitor, in Palliative Radiotherapy for Advanced Tumors.
Study Start Date : February 2007
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Vorinostat
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A I
Study drug
Drug: Vorinostat
Increasing dosing, phase I



Primary Outcome Measures :
  1. DLT [ Time Frame: continously ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455351


Locations
Norway
The Norwegian Radium Hospital
Oslo, Norway, NO-0310
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Director: Sigbjørn Smeland, MD,PhD Norwegian Radium Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Svein Dueland (PI), Rikshospitalet-Radiumhospitalet HF
ClinicalTrials.gov Identifier: NCT00455351     History of Changes
Other Study ID Numbers: EudraCTnumber 2006-003631-76
First Posted: April 3, 2007    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: July 2011

Keywords provided by Oslo University Hospital:
Palliative treatment
Max. tolerable dose

Additional relevant MeSH terms:
Pelvic Neoplasms
Neoplasms by Site
Neoplasms
Vorinostat
Histone Deacetylase Inhibitors
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action