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AMG 102 at/kg

Phase 2

Advanced Malignant Glioma | Small molecule | Oncology |Amgen Inc.|Last Updated: Apr 27, 2015

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

AMG 102 at/kg · 2 trials · 2 indications

Phase 2 2
NCT00422019A Phase II Study to Treat Subjects With Advanced Renal Cell CarcinomaAdvanced Renal Cell Carcinoma
COMPLETED61 Analytics
NCT00427440A Phase II Study to Treat Advanced Malignant GliomaAdvanced Malignant Glioma
COMPLETED61 Analytics
PHASE2COMPLETED
A Phase II Study to Treat Subjects With Advanced Renal Cell Carcinoma
Advanced Renal Cell CarcinomaUnlock trial analytics
PHASE2COMPLETED
A Phase II Study to Treat Advanced Malignant Glioma
Advanced Malignant GliomaUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the objective response rate in subjects with advanced renal cell carcinoma receiving AMG 102 treatment
9 weeks from first dose of AMG 102
Assess best objective confirmed response rate in subjects with advanced malignant glioma receiving AMG 102 treatment
Week 9 from first dose of AMG 102

Secondary Endpoints

To estimate the overall survival and progression free survival rates in this population
8 week intervals
To assess the duration of response and time to response in this population
treatment period
To assess the pharmacokinetics of AMG 102 in subjects with advanced renal cell carcinoma
Weeks 1, 5, and 9
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AMG 102 at 20 mg/kg Dose LevelEXPERIMENTALUp to 40 subjects will be treated at 20 mg/kg of AMG 102 Q2W (every 2 weeks) depending upon the stage of the study and number of responses observed.
AMG 102 at 10 mg/kg Dose LevelEXPERIMENTALUp to 40 subjects will be dosed at 10mg/kg of AMG 102 Q2W (every two weeks) based upon the stage of the study and number of responses observed.

Interventions

NameTypeDescription
AMG 102 at 10 mg/kgDRUGAMG 102 at 10 mg/kg IV (in the vein) every 2 weeks
AMG 102 at 20 mg/kgDRUGAMG 102 at 20 mg/kg IV (in the vein) every 2 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * documented histologically confirmed advanced or metastatic renal cell carcinoma with the primary tumor in place or following nephrectomy * measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (CT or MRI) or ≥ 10 mm by spiral ...

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Frequently asked questions about AMG 102 at/kg

What is AMG 102 at/kg used for?

AMG 102 at/kg is an investigational small molecule being studied for the treatment of advanced renal cell carcinoma and advanced malignant glioma. It is in Phase 2 clinical development and has not been approved by the FDA.

Who makes AMG 102 at/kg?

AMG 102 at/kg is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is currently in Phase 2 clinical trials for oncology indications.

What phase is AMG 102 at/kg in?

AMG 102 at/kg is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Two Phase 2 studies have been completed, one for advanced renal cell carcinoma and one for advanced malignant glioma.

What clinical trials is AMG 102 at/kg in?

AMG 102 at/kg has been studied in two completed Phase 2 trials. NCT00422019 evaluated the drug in patients with advanced renal cell carcinoma, and NCT00427440 evaluated it in patients with advanced malignant glioma. Each trial enrolled 61 participants.

Is AMG 102 at/kg a small molecule?

Yes, AMG 102 at/kg is a small molecule therapeutic. It is being developed by Amgen Inc. for the treatment of advanced renal cell carcinoma and advanced malignant glioma, and it is currently in Phase 2 clinical trials.