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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001031-22-GB

Enrollment

Registered

2006-09-18

Start date

2007-12-18

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small-cell lung cancer

Interventions

Trade Name: Viracept Pharmaceutical Form: Film-coated tablet INN or Proposed INN: NELFINAVIR MESILATE CAS Number: 159989647 Concentration unit: mg milligram(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 Inhibitors simvastatin, atorvastatin Neuroleptics pimozide Sedatives/hypnotics midazolam, Others Viagra, terfenadine

Design outcomes

Primary

Measure	Time frame
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 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	—

Measure

Time frame

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 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

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026