Clinical trial · Interventional
Lapatinib in Treating Patients With Recurrent Glioblastoma Multiforme
A Phase I/II Study of GW572016 in Patients With Recurrent Malignant Glioma
NCT00099060CI-TRIAL-00013567completedPhase 1 / Phase 2ClinicalTrials.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)
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of lapatinib and to see how well it works in treating patients with recurrent glioblastoma multiforme.
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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lapatinib ditosylate | Drug | Lapatinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Toxicity for phase I assessed by CTCAE v.3.0 MacDonald criteria
- timeFrame
- 7 years
- measure
- Response for phase II
- timeFrame
- 7 years
Secondary outcomes (2)
- measure
- Correlative studies on archival tissue
- timeFrame
- 7 years
- measure
- Pharmacokinetics
- timeFrame
- 7 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant glioblastoma multiforme * Recurrent or progressive disease after prior primary treatment with radiotherapy with or without adjuvant chemotherapy * Bidimensionally measurable disease on CT scan or MRI with at least one lesion ≥ 1 cm x 1 cm * Paraffin embedded tumor sample available * Concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) required for phase I of the study * Patients in phase II of the study may or may not be receiving EIAEDs PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * LVEF ≥ 50% by echocardiogram or MUGA * No myocardial infarction within the past 6 months * No congestive heart failure * No unstable angina * No active cardiomyopathy * No cardiac arrhythmia * No uncontrolled hypertension Pulmonary * No pulmonary disease requiring oxygen Neurologic * No preexisting peripheral neuropathy ≥ grade 3 * No history of significant neurologic disorder that would preclude study compliance or ability to give informed consent Gastrointestinal * No upper gastrointestinal or other conditions that would preclude compliance with oral medication * No active peptic ulcer disease Other * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor * No immune deficiency * No history of significant psychiatric disorder (e.g., uncontrolled psychotic disorders) that would preclude study compliance or ability to give informed consent * No other serious illness or medical condition that would preclude study participation * No known hypersensitivity to compounds of similar chemical or biological composition to lapatinib * No active uncontrolled or serious infection * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or other hematopoietic growth factors * Concurrent hematopoietic growth factors allowed for treatment of acute toxicity (e.g., febrile neutropenia) Chemotherapy * See Disease Characteristics * No prior chemotherapy for recurrent disease * No more than one prior chemotherapy regimen in the adjuvant setting * At least 6 months since prior adjuvant chemotherapy Endocrine therapy * Concurrent steroids allowed provided the dose is stable for at least 14 days before study entry Radiotherapy * See Disease Characteristics * At least 6 weeks since prior radiotherapy Surgery * At least 2 weeks since prior major surgery Other * H2 blockers and proton pump inhibitors allowed, unless they are CYP3A4 inducers or inhibitors * At least 7 days since prior and no concurrent administration of any of the following CYP3A4 inhibitors: * Clarithromycin * Erythromycin * Troleandomycin * Telithromycin * Ciprofloxacin * Norfloxacin * Itraconazole * Ketoconazole * Voriconazole * Fluconazole (≤150 mg/day allowed) * Nefazodone * Fluovoxamine * Delavirdine * Nelfinavir * Amprenavir * Ritonavir * Indinavir * Saquinavir * Lopinavir * Verapamil * Diltiazem * Aprepitant * Grapefruit or grapefruit juice * Bitter orange * At least 14 days since prior and no concurrent administration of any of the following CYP3A4 inducers: * Rifampin * Rifabutin * Rifapentine * Efavirenz * Nevirapine * Hypericum perforatum (St. John's wort) * Modafinil * At least 6 months since prior and no concurrent administration of amiodarone * Antacids (e.g., mylanta, maalox, tums, rennies) must be administered ≥ 1 hour before and ≥ 1 hour after study drug * At least 2 days since prior and no concurrent cimetidine * No other concurrent anti-cancer agents * No other concurrent investigational therapy
References
Publications (0)
Data not yet available
No reference posted for this study.