Investigation of the efficacy of lapatinib plus temozolomide combination, in recurrent brain tumors. A phase I/II study.

Phase 1

Completed

• Conditions: patients with recurrent or refractory gliomas; Cancer - Brain

• Registration Number: ACTRN12611000418976
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Written informed consent 2. Age >18 years 3. Radiographic evidence of recurrent glioma (Grade IV glioblastoma multiforme or Grade III anaplastic astrocytoma). Patients should have achieved Complete Response (CR), Partial Response (PR) or Stable Disease (SD) with prior treatment with radiation (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 Response Evaluation Criteria In Solid Tumors (RECIST) 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 6. Adequate haematological function (Absolute Neutrophils Count>=1.5 x 10^9/Litre (L), Platelet count>=100 x 10^9/L and Haemoglobin>=9grams per deciliter (g/dL) 7. Adequate liver and renal function (Total bilirubin <1.5 x upper limit of normal, aspartate aminotransferase (AST), Alanine transaminase (ALT) <2.5x Upper Limit of Normal (ULN) in patients (pts) without liver metastases; <5xULN in pts with liver metastases, serum creatinine <=1.25xULN or calculated creatinine clearance >=50 Millilitre per minute (mL/min) 8. Left Ventricular Ejection Fraction (LVEF) within institutional normal range 9. All patients must have archived tumour tissue available for translational research.10. Drugs and several herbal constituents (e.g. bergamontin and glabridin), which are inducers or inhibitors of Cytochrome P450 3A4 (CYP3A4) must not be taken within 10 days prior to initiation of treatment and are prohibited while the patient is being treated with lapatinib 11. If a patient requires anticoagulant therapy the patient may remain on study but should be monitored carefully.

Exclusion Criteria

1. Pregnant or lactating women
2. Clinically significant non-controlled cardiovascular disease
3. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment
4. Prior treatment with Epidermal Growth Factor Receptors (EGFR) inhibitors will not be allowed
5. 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 complications
7. Treatment with Enzyme-Inducing Anti-Epileptic Drugs (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
• Study Design: Not specified