INVESTIGATION OF THE EFFICACY OF LAPATINIB MONOTHERAPY AND TEMOZOLOMIDE PLUS LAPATINIB COMBINATION, IN RECURRENT HIGH GRADE GLIOMAS. A PHASE I/II STUDY. - N/A

• Conditions: Refractory glioblastoma multiforme.

• Registration Number: EUCTR2007-006656-19-GR
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-28
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Written informed consent 2. Age ³18 years3. Radiographic evidence of recurrent glioma (Gr IV glioblastoma multiforme or Gr III anaplastic astrocytoma). Patients should have achieved CR, PR or SD with prior treatment with RT/ temozolomide (adjuvant or 1st line setting). Early recurrence patients may be included in the phase I study.4. Measurable disease at screening according to RECIST5. ECOG performance status (PS) 0-26. Adequate haematological function (ANC =1.5 x 109/L, Platelet count =100 x 109/L and Haemoglobin =9 g/dL)7. Adequate liver and renal function (Total bilirubin <1.5 x upper limit of normal, AST, ALT <2.5xULN in pts without liver metastases; <5xULN in pts with liver metastase, serum creatinine =1.25xULN or calculated creatinine clearance =50 mL/min)8. LVEF within institutional normal range9. All patients must have archived tumour tissue available for translational research – In a subset of suitable patients fresh tumour tissue will be obtained at screening by stereotactic biopsy and at week 4 of lapatinib treatment.10. Drugs and several herbal constituents (e.g. bergamontin and glabridin), which are inducers or inhibitors of CYP3A4 must not be taken within 10 days prior to initiation of treatment and are prohibited while the patient is being treated with lapatinib (a detailed list is provided in section 5.7)11. If a patient requires anticoagulant therapy the patient may remain on study but should be monitored carefully.
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

1. Pregnant or lactating women2. Clinically significant non-controlled cardiovascular disease 3. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment4. Prior treatment with EGFR inhibitors will not be allowed5. Known hypersensitivity to drugs chemically related to lapatinib 6. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications7. Treatment with EIAEDs will be excluded, use of valproate will be permitted. 8. Patients will be excluded if unable to swallow tablets.9. Active infection.

Study & Design

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