NCT00455351

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

May 8, 2023

Status Verified

May 1, 2023

Enrollment Period

2.1 years

First QC Date

April 2, 2007

Last Update Submit

May 5, 2023

Conditions

Pelvic CancerRadiotherapy

Keywords

Palliative treatmentMax. tolerable dose

Outcome Measures

Primary Outcomes (1)

  • DLT

    continously

Study Arms (1)

A I

EXPERIMENTAL

Study drug

Drug: Vorinostat

Interventions

VorinostatDRUG

Increasing dosing, phase I

A I

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pelvic malignancy
  • Palliative radiation treatment planed
  • ECOG \<3
  • Age\>18 years

You may not qualify if:

  • Previous pelvic radiotherapy
  • Uncontrolled diarrhea
  • Insulin-dependent diabetes mellitus
  • BMI\<18.5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Norwegian Radium Hospital

Oslo, NO-0310, Norway

Location

Related Publications (2)

  • Ree AH, Dueland S, Folkvord S, Hole KH, Seierstad T, Johansen M, Abrahamsen TW, Flatmark K. Vorinostat, a histone deacetylase inhibitor, combined with pelvic palliative radiotherapy for gastrointestinal carcinoma: the Pelvic Radiation and Vorinostat (PRAVO) phase 1 study. Lancet Oncol. 2010 May;11(5):459-64. doi: 10.1016/S1470-2045(10)70058-9. Epub 2010 Apr 6.

    PMID: 20378407RESULT

  • Bratland A, Dueland S, Hollywood D, Flatmark K, Ree AH. Gastrointestinal toxicity of vorinostat: reanalysis of phase 1 study results with emphasis on dose-volume effects of pelvic radiotherapy. Radiat Oncol. 2011 Apr 8;6:33. doi: 10.1186/1748-717X-6-33.

    PMID: 21473790DERIVED

MeSH Terms

Conditions

Pelvic Neoplasms

Interventions

Vorinostat

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesHydroxamic AcidsHydroxylaminesHydroxy AcidsCarboxylic Acids

Study Officials

  • Sigbjørn Smeland, MD,PhD

    Norwegian Radium Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior physician

Study Record Dates

First Submitted

April 2, 2007

First Posted

April 3, 2007

Study Start

February 1, 2007

Primary Completion

March 1, 2009

Study Completion

August 1, 2009

Last Updated

May 8, 2023

Record last verified: 2023-05

Locations

NO(1)