Recurrent Glioblastoma MedDRA version: 6.1 Level: PT Classification code 10018336
Conditions
Interventions
Product Name: EPOTHILONE
Product Code: ZK219477
Pharmaceutical Form: Powder and solvent for solution for infusion
Current Sponsor code: ZK 219477
Concentration unit: mg milligram(s)
Concentration type
Sponsors
ISTITUTO NEUROLOGICO CARLO BESTA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically proven at diagnosis GMB - Age 18-70 years - KPS 70 - Life expectancy of at least 3 months - Presence of at least one bi-dimensionally measurable lesion on gadolinium Gd -enhanced MRI, indicating progressive or recurrent disease at least 8 weeks after standard external-beam radiotherapy - Recurrence or progression after treatment with radiotherapy and temozolomide. Also patients with residual disease after surgery for recurrent GBM will be included - Adequate bone marrow reserve leucocytes 3,500/ml, ANC 1,500, platelets 100,000/ml ; normal baseline liver serum bilirubin 20umol/L , renal serum creatinine 150umol/L and cardiac function - Absence of infectious disease, debilitatig chronic diseases, known psychiatric disorders - Corticosteroid dose stable for at least 1 week - Adequate recovery from previous surgery, radiation and chemotherapy - Negative pregnancy test at enrolment in females of chil-bearing potential - Agreement to use effective contraception methods in adults of reproductive potential - Written informed consent 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: - Pregnancy - Chemotherapy or radiotherapy within 4 weeks before screening - History of allergic reactions due to compounds of similar chemical or biologic composition to ZK219477 - Uncontrolled intercurrent illness including, but not limited, to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrythmia or psychiatric illness/social situations that would limit compliance with study requirements - HIV infection - Any prior treatment with epothilones, other tubulin-targetting as taxanes e. paclitaxel, docetaxel and vinca alcaloids e.g. vincristine, vinblastine, vinorelbine - Peripheral neuropathy - Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix - Active infection - Breast-feeding - Subjects who have received an experimental drug or have participated in a clinical trial within 3 months prior to screening - Employees of the investigator or study centre with direct involvement in the proposed study or other studies under the direction of thet investigator or study centre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate safety and efficacy of ZK219477 in the treatment of pre-treated, recurrent GBM patients. An optional PK study will be performed in selected patients.;Secondary Objective: Response rates CR PR , Median Survival Time MST .;Primary end point(s): Progession Free Survival at 6 months PFS-6 . Treatment toxicity will be assessed using CTCAE, Version 3.0, except for neurological toxicity that will be assessed also by means of the Scottish Gynaecological Cancer Trial Group SGCTG Neurotoxicity Score and elecromyography. | — |
Countries
Italy
Outcome results
None listed