The Potentiation of Efficacy of Radiotherapy in Non-Small-Cell Lung Cancer (NSCLC) by Inhibition of Akt Activation - Lung Radiotherapy and Nelfinavir

Phase 1

• Conditions: on-small-cell lung cancer

• Registration Number: EUCTR2006-001031-22-GB
• Lead Sponsor: Institute of Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-18
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

- Histologically verified NSCLC including squamous cell carcinoma, adenocarcinoma, and large cell anaplastic carcinoma
- Patients with stage II or III NSCLC unsuitable for radical treatment to the primary tumour, where high dose palliative radiotherapy is considered appropriate (CT scan to have been performed within 28 days prior to trial entry)
- Performance status WHO 0 - 2
- clinically or radiographically measurable disease
- absolute neutrophil count >=1500/mm3
- Platelets =100 x 109/L (=100000/mm3)
- Serum creatinine =1.5 times upper limit of normal
- Bilirubin =1.5 times upper limit of normal
- Serum AST = 1.5 x upper limit of normal

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients with metastatic disease
- Patients diagnosed with heart disease or diabetes mellitus
- Previous radiotherapy to the chest
- Chemotherapy within 4 weeks of the start of experimental treatment
- The presence of another malignancy, where the extent of disease or treatment for that condition may interfere with the study endpoints
- Patients already taking a Protease Inhibitor
- Patients taking drugs contraindicated with NFV, unless stopped 2 weeks or more before start of study:

Antiarrhythmics amiodarone, quinidine
Antimycobacterials rifampicin
Ergot derivatives Dihydroergotamine, ergonovine, ergotamine, methylergonovine
Herbal products St. John’s Wort
HMG-CoA Reductase Inhibitorssimvastatin, atorvastatin
Neuroleptics pimozide
Sedatives/hypnotics midazolam,
Others Viagra, terfenadine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To document toxicity related to NFV given in combination with radiotherapy ;Secondary Objective: To correlate the drug's efficacy with biological endpoints of perturbation of the signal transduction pathway<br>To assess the enhancement of radiation response in NSCLC by inhibition of Akt activation with NFV;Primary end point(s): •Treatment related toxicity (particularly lung and oesophageal) assessed by the World Health Organisation (WHO) Common Toxicity Criteria (CTCAE)v3