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AMG 479

Phase 2

Neuroendocrine Tumor | Small molecule | Oncology |Amgen Inc.|Last Updated: Mar 8, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

AMG 479 · 1 trial · 3 indications

Phase 2 1
NCT01024387AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine TumorsNeuroendocrine Tumor
COMPLETED60 Analytics
PHASE2COMPLETED
AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors
Neuroendocrine TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Response Rate
Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks).

Objective response rate is the percentage of patients achieving partial response (PR) or complete response (CR) per RECIST 1.0 criteria. For target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR status must be confirmed by repeat assessments performed no fewer than 4 weeks or more than 6 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

Secondary Endpoints

Duration of Response
Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks).
Grade 3-4 Toxicity Rate
Toxicity was evaluated every cycle (3 weeks) on treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks).
Progression Free Survival
Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort were followed up to 20 months.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AMG 479EXPERIMENTALPatients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.

Interventions

NameTypeDescription
AMG 479DRUG -
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Eligibility Criteria

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

Inclusion Criteria: * Locally unresectable or metastatic carcinoid or pancreatic neuroendocrine tumors. To be classified as having a pancreatic neuroendocrine tumor, patients must have clinical evidence of currently having or having had a primary pancreatic neuroendocrine lesion. * Measurable disea...

Countries:United States
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Frequently asked questions about AMG 479

What is AMG 479 used for?

AMG 479 is an investigational small molecule being studied for the treatment of neuroendocrine tumors, including carcinoid tumors and pancreatic neuroendocrine tumors. It is being developed by Amgen Inc. and is currently in Phase 2 clinical development.

What does AMG 479 target?

AMG 479 is a small molecule, but its specific molecular target has not been disclosed. It is being investigated for its potential role in treating neuroendocrine tumors, though the exact mechanism of action is not publicly detailed.

Who makes AMG 479?

AMG 479 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 2 clinical development for neuroendocrine tumors.

What phase is AMG 479 in?

AMG 479 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, with no active trials currently ongoing.

What clinical trials is AMG 479 in?

AMG 479 has been studied in one completed Phase 2 clinical trial, identified as NCT01024387. This trial, titled 'AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors,' enrolled 60 participants in the United States and was not randomized or blinded.

Is AMG 479 the same as other drugs?

AMG 479 is not known by any alternative names. It is a distinct investigational small molecule being developed by Amgen Inc. for the treatment of neuroendocrine tumors.