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AMG 386/kg

Phase 2

Gastrointestinal Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: May 7, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment171

FDA Designations

No designations recorded

Clinical trial landscape

AMG 386/kg · 1 trial · 1 indication

Phase 2 1
NCT00583674Phase 2 Study of AMG 386 (20060439) in Combination With Cisplatin & Capecitabine in Subjects With Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal AdenocarcinomaGastrointestinal Cancer
COMPLETED171 Analytics
PHASE2COMPLETED
Phase 2 Study of AMG 386 (20060439) in Combination With Cisplatin & Capecitabine in Subjects With Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma
Gastrointestinal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression Free Survival (PFS)
22 months

Secondary Endpoints

Safety and Tolerability
22 months
Objective Response Rate (ORR)
22 months
Duration of Response (DOR)
22 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BEXPERIMENTAL -
AEXPERIMENTAL -
CACTIVE_COMPARATOR -

Interventions

NameTypeDescription
AMG 386 placeboDRUGAMG 386 placebo IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
AMG 386 10mg/kgDRUGAMG 386 10 mg/kg IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
AMG 386 3mg/kgDRUGAMG 386 3 mg/kg IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
CisplatinDRUGCisplatin 80 mg/m2 IV Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
CapecitabineDRUGCapecitabine1000 mg/m2 PO BID x 14 days Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Disease Related * Histologically or cytologically confirmed adenocarcinoma of the stomach, gastroesophageal junction or distal esophagus with metastatic disease * Measurable or non-measurable disease per RECIST Guidelines * Prior gastrectomy (total or partial) may be al...

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Frequently asked questions about AMG 386/kg

What is AMG 386 used for?

AMG 386 is an investigational oncology drug being studied for advanced renal cell carcinoma, advanced solid tumors, carcinoma, gastrointestinal cancer, fallopian tube cancer, and locally recurrent and metastatic breast cancer. It is in Phase 2 clinical development and is not yet approved by the FDA.

Who makes AMG 386?

AMG 386 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is an investigational small molecule in Phase 2 clinical development for multiple oncology indications.

What phase is AMG 386 in?

AMG 386 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials have been completed, including a Phase 2 study in advanced renal cell carcinoma.

What clinical trials is AMG 386 in?

AMG 386 has been studied in several completed clinical trials, including NCT00467025, a Phase 2 study in advanced renal cell carcinoma; NCT01331941, a pharmacokinetic study in advanced solid tumors and renal impairment; NCT01666977, a Phase 1b/2 trial in non-small cell lung cancer; and NCT01992341, a drug-drug interaction study with paclitaxel.

Is AMG 386 the same as trebananib?

AMG 386 is also known as trebananib. It is an investigational oncology drug being developed by Amgen Inc. for multiple cancer types, including advanced renal cell carcinoma and advanced solid tumors.