Clinical trial · Interventional
Study With Nelfinavir and Combined Radiochemotherapy for Glioblastoma
Phase I/II Study for Patients With Newly Diagnosed Glioblastoma Testing Nelfinavir in Combination With Concomitant Temozolomide and Radiotherapy.
NCT00694837CI-TRIAL-00017461completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objectives of the trial are: To assess safety, tolerability and activity of nelfinavir given neo-adjuvant and concomitant to chemoradiotherapy with temozolomide in patients with a newly diagnosed glioblastoma multiforme. To describe the possible effect of nelfinavir on functional imaging To describe the activity of nelfinavir in vivo on blocking the AKT pathway.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nelfinavir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- B
- interventionNames
- Drug: nelfinavir
Primary outcomes (1)
- measure
- Fase I: To determine the MTD of nelfinavir as an adjuvant in the radiochemotherapy treatment in primary glioblastoma patients. Fase 2: Progression free survival at 6 months
- timeFrame
- Fase 1: after treatment; fase 2: 6 months after treatment
Secondary outcomes (1)
- measure
- Fase 1/2: Incidence of acute toxicity; OS; Metabolic ratios of SUV of serial 18F-FDG: assessed by PET-CT.Fase 1:6-months PFS; Relative blood flow measurement by perfusion MRI. Fase 2: PFS at 12 months; Phosphorylation of AKT in tumour tissue.
- timeFrame
- fase 1: 6 months after treatment; fase 2: 12 months after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed glioblastoma multiforme at primary diagnosis * Tumours which do enhance on pre-operative imaging * Age \>=18-65 years * WHO performance status 0-2, RTOG- RPA class III-IV. * No recent (\< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction) * Patient able to tolerate full course of radiotherapy * No previous radiotherapy to the head and neck area. * Prior neurosurgery within 6 weeks of treatment * No previous irradiation of the brain. * No previous chemotherapy * No prior or concurrent medical condition which would make treatment difficult to complete. Medication with steroids is allowed. * No use of terfenadine, astemizol, cisapride, sildenafil, lovastatin or simvastatin and other concurrent medication that is metabolized by the CYP3A4 isoenzyme and cannot be replaced with other equivalent medications for the period of the study: antiarrhythmics (amiodarone, quinidine), neuroleptics (pimozide), sedative/hypnotic agents (midazolam, triazolam), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), HMG-CoA reductase inhibitors (atorvastatin), rifampin, rifabutin, felodipine, nifedipine, and sildenafil or St. John's wort. * Adequate haematological, renal and hepatic function * No uncontrolled infectious disease, absence of known HIV infection, chronic hepatitis B or hepatitis C infection * Absence of any medical condition, which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction) * All patients of reproductive potential (male and female) must use effective contraception for the whole duration of the treatment and until 6 months thereafter. Females must not be pregnant or lactating * Willing and able to comply with the study prescriptions * Written informed consent before patient registration Exclusion Criteria: The opposite from above
References
Publications (0)
Data not yet available
No reference posted for this study.