Pelvic CancerPhase 1PRAVONCT00455351

Vorinostat and Palliative Radiotherapy

A Phase 1 study testing Vorinostat in people with Pelvic Cancer and Radiotherapy, run by Oslo University Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Phase I study. Side-effects when combined with standard palliative radiotherapy. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Pelvic Cancer, Radiotherapy
What is being tested?: Vorinostat
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteNorway
Study dates: Feb 2007to Aug 2009
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Norway1 site

The Norwegian Radium Hospital
Oslo, NO-0310

Other trials in Norway

About this study

Official title: 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.

Conditions: Pelvic Cancer, Radiotherapy
Being tested: Vorinostat
Keywords: Palliative treatment, Max. tolerable dose
Medical subject headings: Pelvic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VorinostatDrug
Increasing dosing, phase I

Study groups in NCT00455351
Study group	Role	What they receive
A I	Experimental	Study drug Receives: Drug: Vorinostat

What is being measured

The primary outcome is the main question the study is designed to answer.

DLT
Measured: continously

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Aug 2009

First posted3 Apr 2007 (estimated)
Study startFeb 2007
Primary completionMar 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Pelvic CancerStudies of the same condition, open and under way.
More trials run by Oslo University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00455351
Sponsor's protocol ID: EudraCTnumber 2006-003631-76
Acronym: PRAVO
Status last verified: May 2023
First submitted: 2 Apr 2007
Last updated: 8 May 2023
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 20378407
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.
PubMed 21473790

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pelvic Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Study on Suberoylanilide Hydroxyamic Acid (Vorinostat) a Histone Deacetylase Inhibitor, in Palliative Radiotherapy for Advanced Tumors.
ClinicalTrials.gov ID: NCT00455351
Acronym / sponsor ID: PRAVO / EudraCTnumber 2006-003631-76
Conditions: Pelvic Cancer, Radiotherapy
Keywords: Palliative treatment, Max. tolerable dose
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Oslo University HospitalUniversity, hospital or other
Study start: Feb 2007
Primary completion: Mar 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 3 Apr 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
A I	Experimental	Drug: VorinostatStudy drug

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VorinostatIncreasing dosing, phase I	Drug	A I

Primary outcome

DLT
Time frame: continously

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
Results publication: PubMed 20378407Ree 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.
Derived from this study: PubMed 21473790Bratland 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.

Related trials for Pelvic Cancer

RecruitingPhase 3
An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors
Childhood Malignant Solid Neoplasm, Childhood Malignant Thoracic Neoplasm
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Recruiting
18F-N230A PET/CT Imaging of Nectin-4 Expression in Renal Tumors
Renal Cell Carcinoma (RCC), Renal Pelvic Urothelial Carcinoma
RecruitingObservational study
Health Oriented Protocol for Epidermal Radiodermatitis
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RecruitingObservational study
Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Cancer Treatment
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sigbjørn Smeland, MD,PhD study director

Norwegian Radium Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vorinostat in people with Pelvic Cancer and Radiotherapy, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: continously). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00455351, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023; AzTrials last refreshed its copy on 1 Nov 2026.