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Magnevist

Phase 3

Brain Neoplasms | Small molecule | Oncology |Bayer AG|Last Updated: Dec 15, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

Magnevist · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT00681551Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Patients With Brain MetastasisBrain Neoplasms
COMPLETED45 Analytics
PHASE3COMPLETED
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Patients With Brain Metastasis
Brain NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Diagnostic ability
MRI image in blinded read
Quantitative measurement of the total area of delayed enhancement
30 min post injection

Secondary Endpoints

Visibility
MRI image in blinded read
Diagnostic confidence
MRI image in blinded read
Quantitative measures of area of delayed enhancement and signal intensities
At 5, 10 and 20 minutes post injection
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATOR -
Arm 2EXPERIMENTAL -

Interventions

NameTypeDescription
Magnevist (SH L 451A)DRUGMagnevist at a dose of 0.1 mmol/kg
Magnevist (Gadopentetate dimeglumine, BAY86-4882)DRUGOne intravenous injection per period. Period 1 and 2 are separated by 4 to 14 days.period1:Magnevist 0.1 mmol/kg body weightperiod 2: Magnevist 0.2 mmol/kg body weight
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Patients who are confirmed to have 1-5 metastatic brain tumor by the latest contrast-enhanced cerebral CT or contrast-enhanced cerebral MRI, and the lesion(s) have not been treated by surgery or by stereotactic radiosurgery. Exclusion Criteria: * Patients who are scheduled t...

Countries:JapanUnited StatesArgentina
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Frequently asked questions about Magnevist

What is Magnevist used for?

Magnevist is a small molecule contrast agent studied for use in myocardial infarction and brain neoplasms. Clinical trials have evaluated it for depicting delayed enhancement in patients with documented myocardial infarction and for intra-individual dose comparison in patients with brain metastasis.

Who makes Magnevist?

Magnevist is developed by Bayer AG, which trades under the ticker BAYRY. The company has sponsored clinical trials of the drug in the United States, Argentina, and Japan.

What phase is Magnevist in?

Magnevist is in Phase 3 clinical development. One completed Phase 3 trial evaluated the drug in patients with brain neoplasms, and a completed Phase 2 trial studied it in myocardial infarction. It remains investigational and is not approved.

What clinical trials is Magnevist in?

Magnevist has one completed Phase 2 trial, NCT00310544, which enrolled 73 participants with myocardial infarction in the United States and Argentina. A completed Phase 3 trial, NCT00681551, enrolled 45 participants with brain neoplasms in Japan.

Is Magnevist the same as SH L 451A?

Yes, Magnevist is also known as SH L 451A. The Phase 3 trial in brain metastasis is titled 'Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Patients With Brain Metastasis.'