Trials Sponsors Conditions Drugs Pricing

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastomarecurrent adult brain tumoradult giant cell glioblastomaadult gliosarcoma

Outcome Measures

Primary Outcomes (1)

Maximum tolerated dose and dose-limiting toxicity of AEE788

Secondary Outcomes (5)

Safety
Tolerability
Single-dose and repeated-dose pharmacokinetic profile
Efficacy (response rate, progression-free survival, and overall survival)
Antiangiogenic effects

Study Arms (2)

AEE788 200 mg + RAD001 5 mg

EXPERIMENTAL

AEE788 200 mg qd, RAD001 5 mg qd

Drug: AEE788Drug: everolimus

AEE788 150 mg + RAD001 5mg

EXPERIMENTAL

AEE788 150 mg qd, RAD001 5 mg qod

Drug: AEE788Drug: everolimus

Interventions

AEE788Drug

AEE788 was available in the form of a hard gelatin capsule of 50 mg or 100 mg strengths and packaged in bottles.

AEE788 150 mg + RAD001 5mgAEE788 200 mg + RAD001 5 mg

everolimusDrug

Everolimus was formulated as tablets of 2.5 mg and 5 mg strength and supplied in blister packs.

Also known as:

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme, meeting 1 of the following criteria: * Phase I * In first or second recurrence or relapse * At least 1 measurable or evaluable enhancing lesion by gadolinium MRI (Gd-MRI) of the brain within the past 3 weeks * Phase II, group 1 * In first or second recurrence or relapse by Gd-MRI of the brain within the past 3 weeks * Requires tumor biopsy OR surgical resection for tumor debulking or for confirmation of recurrence * Phase II, group 2 * In first recurrence or relapse * At least 1 bidimensionally measurable enhancing lesion (≥ 1.5 cm\^2 using product of the largest perpendicular diameters) by Gd-MRI of the brain within the past 3 weeks * Multifocal disease allowed PATIENT CHARACTERISTICS: Performance status * Karnofsky 70-100% Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 9 g/dL * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * No acute or chronic liver disease Renal * Total calcium (corrected) normal\* * Creatinine ≤ 1.5 times ULN OR * Creatinine clearance ≥ 50 mL/min * No proteinuria by dipstick OR * Total urinary protein ≤ 500 mg AND creatinine clearance ≥ 50 mL/min by 24-hour urine collection * No acute or chronic renal disease NOTE: \*Supplements allowed Cardiovascular * LVEF ≥ 45% by MUGA or echocardiogram * No complete left bundle branch block * No requirement for a cardiac pacemaker * No congenital long QT syndrome * No ventricular or atrial tachyarrhythmias * No clinically significant resting bradycardia, defined as \< 50 beats per minute * QTc ≤ 480 msec by ECG * No right bundle branch block and left anterior hemiblock (bifascicular block) * No uncontrolled hypertension OR history of labile hypertension * No unstable angina pectoris OR angina pectoris occurrence within the past 3 months * No congestive heart failure * No acute myocardial infarction within the past 3 months * No history of poor compliance with an antihypertensive regimen * No other impaired cardiac function or clinically significant cardiac disease Gastrointestinal * No unresolved diarrhea ≥ grade 2 * No impairment of gastrointestinal (GI) function or GI disease that would significantly alter absorption of study drugs, including any of the following: * Ulcerative disease * Uncontrolled nausea * Vomiting * Malabsorption syndrome Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * Potassium normal\* * Magnesium normal\* * Phosphorus normal\* * Cholesterol ≤ 300 mg/dL (treatment allowed) * Triglycerides ≤ 2.5 times ULN (treatment allowed) * No known HIV positivity * No peripheral neuropathy ≥ grade 2 * No uncontrolled diabetes * No active or uncontrolled infection * No other severe and/or uncontrolled medical condition that would preclude study participation or compliance * No contraindication to MRI, including any of the following: * Cardiac pacemaker * Ferromagnetic metal implants other than those approved as safe for use with magnetic resonance scanners (e.g., some types of aneurysm clips or shrapnel) * Claustrophobia * Obesity exceeding magnetic resonance equipment limits * No other clinically significant primary malignancy requiring active intervention NOTE: \*Supplements allowed PRIOR CONCURRENT THERAPY: Biologic therapy * More than 2 weeks since prior hematopoietic colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) except epoetin alfa * More than 2 weeks since prior immunotherapy and recovered * No concurrent biologic therapy * No concurrent prophylactic hematopoietic growth factors (e.g., G-CSF or GM-CSF) unless approved by the study sponsor Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * Prior polifeprosan 20 with carmustine implant (Gliadel® wafer) allowed * No other concurrent chemotherapy Endocrine therapy * Must be on stable or deceasing doses of steroids for at least 7 days before baseline Gd-MRI of the brain and before starting study drug * No concurrent tamoxifen Radiotherapy * More than 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy Surgery * More than 1 week since prior tumor biopsy * More than 2 weeks since prior surgical resection * More than 2 weeks since prior major non-CNS surgery and recovered * No prior small bowel resection Other * At least 2 weeks since prior and no concurrent enzyme-inducing anticonvulsant drugs * More than 4 weeks since prior investigational drugs and recovered * No prior epidermal growth factor receptor- or ErbB-2-directed therapy (phase II only) * No prior vascular endothelial growth factor (VEGF) or VEGF receptor-directed therapy (phase II only) * No prior mTOR-directed therapy (phase II only) * No concurrent therapeutic warfarin * No concurrent treatment with any medication that may prolong QT interval, including any of the following: * Quinidine * Procainamide * Disopyramide * Amiodarone * Sotalol * Bretylium * Ibutilide * Thioridazine * Mesoridazine * Chlorpromazine * Amitriptyline * Imipramine * Desipramine * Doxepin * Erythromycin * Clarithromycin * Ketoconazole * Halofantrine * Quinine * Chloroquine * Mefloquine * Moxifloxacin * Gatifloxacin * Pimozide * Risperidone * Ziprasidone * Venlafaxine * Maprotiline * Lithium * Pentamidine * Droperidol * Dolasetron * No concurrent digoxin or verapamil * No concurrent tacrolimus * No other concurrent investigational agents

Sponsors & Collaborators

Novartis Pharmaceuticals
Industrylead

Study Sites (3)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Duke Univaersity Medical Center

Durham, North Carolina, 27710, United States

MD Anderson Cancer Center/University of Texas

Houston, Texas, 77030, United States

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaBrain NeoplasmsGliosarcoma

Interventions

AEE 788Everolimus

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal Tumors

Study Officials

Novartis Pharmaceuticals
Novartis Pharmaceuticals
STUDY DIRECTOR

Enrollment

16 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 5, 2005

First Posted

April 6, 2005

Study Start

October 2003

Date type not reported

This date has not been verified as actual or estimated.

AEE788 and Everolimus in Treating Patients With Recurrent or Relapsed Glioblastoma Multiforme

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

AEE788 200 mg + RAD001 5 mg

AEE788 150 mg + RAD001 5mg

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

AEE788 200 mg + RAD001 5 mg

AEE788 150 mg + RAD001 5mg

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations