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AMG 208

Phase 1

Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: Dec 16, 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

AMG 208 · 1 trial · 6 indications

Phase 1 1
NCT00813384A Phase 1 Study of AMG 208 in Subjects With Advanced Solid TumorsCancer
COMPLETED54 Analytics
PHASE1COMPLETED
A Phase 1 Study of AMG 208 in Subjects With Advanced Solid Tumors
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the maximum tolerated dose (MTD) of AMG 208, if possible
3.5 years
To evaluate for clinical responses associated with AMG 208 treatment in subjects (Dose Expansion) with advanced solid malignancies according to RECIST criteria
3.5 years
To characterize the pharmacokinetic (PK) exposure of AMG 208 when administered orally to subjects with advanced solid malignancies
3.5 years
To evaluate the safety and tolerability of AMG 208 in subjects with advanced solid malignancies
3.5 years

Secondary Endpoints

To evaluate for a decrease in tumor cell proliferation associated with AMG 208 treatment in subjects with advanced solid malignancies according to FLT-PET scanning
3.5 years
To assess tumor volume changes after AMG 208 treatment by computed tomography (CT) or magnetic resonance imaging (MRI)
3.5 years
To assess skin specimens for potential biomarkers
3.5 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTALThe dose escalation part of the study is aimed at determining the maximum tolerated dose (MTD), if feasible, and evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 208.
Dose ExpansionEXPERIMENTALThe dose expansion will consist of up to 30 subjects and the dose level of AMG 208 will be dependent upon emerging safety and PK data from the dose escalation part of the study.

Interventions

NameTypeDescription
AMG 208DRUGAMG 208 is a small molecule inhibitor of c-Met which is a well-characterized receptor tyrosine kinase expressed on the surface of epithelial cells. C-Met receptor signaling has been shown to play a key role in the survival of cancer cells. AMG 208 inhibits both ligand-dependent and ligand-independent c-Met cellular growth regulation. Inhibition of c-Met signaling with AMG 208 provides a potential mechanism for blocking tumor growth and survival.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Men or women ≥ 18 years old * Subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy * Measurable disease per RECI...

Countries:United States
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Frequently asked questions about AMG 208

What is AMG 208 used for?

AMG 208 is an investigational small molecule being studied for the treatment of cancer, specifically advanced solid tumors. It is being developed by Amgen Inc. (NASDAQ: AMGN) as a potential oncology therapy.

What does AMG 208 target?

The specific molecular target of AMG 208 has not been disclosed in available information. It is a small molecule being investigated for its potential anti-cancer activity in patients with advanced solid tumors.

Who makes AMG 208?

AMG 208 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The drug is currently in clinical development for the treatment of cancer.

What phase is AMG 208 in?

AMG 208 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being evaluated for safety and efficacy in clinical trials.

What clinical trials is AMG 208 in?

AMG 208 has been studied in one completed Phase 1 clinical trial, identified as NCT00813384, titled "A Phase 1 Study of AMG 208 in Subjects With Advanced Solid Tumors." This trial enrolled 54 participants in the United States.

Is AMG 208 the same as any other drug?

No alternative names for AMG 208 have been reported. It is identified solely by its investigational code name AMG 208 in clinical trial records and development documentation.