Phase I/II study for patients with newly diagnosed glioblastoma testing nelfinavir in combination with radiotherapy and concomitant and adjuvant temozolomide

Phase 1

• Conditions: Phase I/II study for patients with newly diagnosed glioblastoma testing nelfinavir in combination with radiotherapy and concomitant and adjuvant temozolomide; MedDRA version: 9.1Level: LLTClassification code 10018336Term: Glioblastoma; MedDRA version: 9.1Level: LLTClassification code 10018337Term: Glioblastoma multiforme

• Registration Number: EUCTR2008-001078-34-NL
• Lead Sponsor: Maastro Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-11
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

•Histological confirmed glioblastoma multiforme at primary diagnosis
•Tumours which do enhance on pre-operative imaging
•Age >=18-65
•WHO performance status 0-2, RTOG- RPA class III-IV.
•No recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
•Willing and able to comply with the study prescriptions
•Have given written informed consent before patient registration
•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 (See concomitant treatment chapter).
•No uncontrolled infectious disease
•No use of terfenadine, astemizol, cisapride, sildenafil, lovastatin or simvastatin
•No 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 (lovastatin, simvastatin, atorvastatin), rifampin, rifabutin, felodipine, nifedipine, and sildenafil or St. John's wort.
•Adequate haematological, renal and hepatic function
•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

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

the opposite of the above

Study & Design

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