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Nelfinavir, a Phase I/Phase II Rectal Cancer Study

NCT00704600 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-12-08

No results posted yet for this study

Summary

The aim is to study safety and activity of nelfinavir , added to standard chemoradiotherapy in patients with locally advanced rectal cancer. Furthermore analysis of the effect of nelfinavir combined with chemoradiation on tumour tissue will be studied

Conditions

Interventions

DRUG

nelfinavir

Phase I: * take nelfinavir tablets (minimum 6, maximum 10) starting 7 days before start of chemoradiotherapy, for 45 days * day 0 and day 7 and week 2-3-4-5-6-7 weekly blood sample * day 0: PET-CT Phase II: * take nelfinavir tablets (MTD from phase 1) starting 7 days before start of chemoradiotherapy, for 45 days * day 0 and day 7 and week 2-3-4-5-6-7 weekly blood sample * day 7 biopsy * day 7, 21 and week 15 :PET-CT + perfusion CT

Sponsors & Collaborators

  • Maastricht Radiation Oncology

    lead OTHER

Principal Investigators

  • Ph. Lambin, MD PhD · Maastro Clinic, The Netherlands

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-09-30
Completion
2013-07-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00704600 on ClinicalTrials.gov