Vorinostat and Palliative Radiotherapy (PRAVO)

University of Oslo (UIO)

Status and phase: Completed; Phase 1

Conditions: Pelvic Cancer; Radiotherapy

Treatments: Drug: Vorinostat

Study type: Interventional

Funder types: Other

Identifiers

NCT00455351

EudraCTnumber 2006-003631-76

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

A I

Experimental group

Description:

Study drug

Treatment:

Drug: Vorinostat