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AMG 162

Phase 3

Low Bone Mineral Density | Small molecule | Endocrine |Amgen Inc.|Last Updated: Oct 17, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

AMG 162 · 5 trials · 7 indications

Phase 3 4Phase 2 1
NCT00950911Open Label Extension to SRE Studies in United Kingdom and Czech Republic OnlyBone Metastases in Men With Hormone-Refractory Prostate Cancer
COMPLETED35 Analytics
NCT00325468An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral DensityLow Bone Mineral Density
COMPLETED200 Analytics
NCT00089674AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate CancerProstate Cancer
COMPLETED1,468 Analytics
NCT00091793Study to Evaluate AMG 162 in the Prevention of Postmenopausal OsteoporosisPostmenopausal Osteoporosis
COMPLETED332 Analytics
PHASE3COMPLETED
Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only
Bone Metastases in Men With Hormone-Refractory Prostate Cancer
NCT0095091135
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PHASE3COMPLETED
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
Low Bone Mineral Density
NCT00325468200
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PHASE3COMPLETED
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
Prostate Cancer
NCT000896741,468
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PHASE3COMPLETED
Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
Postmenopausal Osteoporosis
NCT00091793332
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Study Endpoints

Primary Endpoints

Number of Participants Survived
2 years
Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
8 years
Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
8 years
Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
8 years
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
24 months

Lumbar Spine Bone Mineral Density Percent Chnage From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
12 months

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Secondary Endpoints

Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8
8 years
Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8
8 years
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24
24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
AMG 162EXPERIMENTALAMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42
PlaceboPLACEBO_COMPARATOR -
100 mg AMG 162ACTIVE_COMPARATOR -
60 mg AMG 162ACTIVE_COMPARATOR -
14 mg AMG 162ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
amg 162DRUG120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first.
PlaceboDRUG60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30
100 mg AMG 162DRUG100 mg AMG 162 (denosumab) SC every 6 months
60 mg AMG 162DRUG60 mg AMG 162 (denosumab) SC every 6 months
14 mg AMG 162DRUG14 mg AMG 162 (denosumab) SC every 6 months
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Subjects currently enrolled in study 20050103, 20050136, or 20050244 * Subjects must sign the informed consent before any study specific procedures are performed Exclusion Criteria: * Developed sensitivity to mammalian cell derived drug products during the 20050103, 20050136...

Countries:CzechiaUnited Kingdom
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Frequently asked questions about AMG 162

What is AMG 162 used for?

AMG 162 is an investigational small molecule being studied for bone-related conditions including prostate cancer, breast cancer, bone metastases in men with hormone-refractory prostate cancer, low bone mineral density, osteoporosis, and postmenopausal osteoporosis. It is in Phase 3 clinical development and is not yet approved.

Who makes AMG 162?

AMG 162 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is currently in Phase 3 clinical trials for multiple bone-related indications.

What phase is AMG 162 in?

AMG 162 is in Phase 3 clinical development. It has completed one Phase 3 trial and is being studied for conditions such as postmenopausal osteoporosis, breast cancer, and bone metastases. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is AMG 162 in?

AMG 162 has been studied in clinical trials including NCT00089661 for bone loss in breast cancer patients, NCT00091793 for prevention of postmenopausal osteoporosis, and NCT00950911 for bone metastases in advanced cancers. These trials are completed.

Is AMG 162 the same as denosumab?

Yes, AMG 162 is also known as denosumab. One clinical trial, NCT00306189, is titled 'A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects,' confirming the alternative name.