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AMG 102 and erlotinib

Phase 1

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Amgen Inc.|Last Updated: Jun 22, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment49

FDA Designations

No designations recorded

Clinical trial landscape

AMG 102 and erlotinib · 1 trial · 1 indication

Phase 1 1
NCT01233687AMG 102 and Erlotinib for Advanced Non-Small Cell Lung CancerCarcinoma, Non-Small-Cell Lung
COMPLETED49 Analytics
PHASE1COMPLETED
AMG 102 and Erlotinib for Advanced Non-Small Cell Lung Cancer
Carcinoma, Non-Small-Cell LungUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants That Experienced a Dose Limiting Toxicity
During first cycle of treatment (3 weeks)

Determination of the safety and recommended phase II dose of AMG 102 when combined with erlotinib for the treatment of patients with advanced, previously-treated NSCLC.

Disease Control Rate (DCR)
Six weeks from initiation of treatment with AMG 102 + Erlotinib

Using RECIST v1.1 criteria, DCR was determined by following equation: the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants / the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.

Secondary Endpoints

Objective Response Rate (ORR/Clinical Response)
Up to 6 months
Progression-free Survival (PFS)
Up to 24 months (after the first patient is accrued)
Overall Survival (OS)
Up to 24 months (after the first evaluable patient is accrued)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AMG 102 and erlotinibEXPERIMENTALCombination of AMG 102 and erlotinib

Interventions

NameTypeDescription
AMG 102 and erlotinibDRUGDose Level -2 Dose level -1 Dose Level 0 AMG 102 5 mg/kg 7.5 mg/kg 15 mg/kg Erlotinib 150 mg 150 mg 150 mg The first cohort of patients in the phase I portion will start at dose level 0 of AMG102.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Patients must have baseline evaluations performed prior to the first dose of study drug and must meet all inclusion and exclusion criteria. Results of all baseline evaluations, which assure that all inclusion and exclusion criteria have been satisfied, must be reviewed by a Physician Investigator pr...

Countries:United States
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Frequently asked questions about AMG 102 and erlotinib

What is AMG 102 used for?

AMG 102 is an investigational oncology drug being studied for the treatment of cancer, including non-small-cell lung cancer, glioblastoma multiforme, and castrate-resistant prostate cancer. It is a small molecule being developed by Amgen Inc. and is currently in clinical trials.

Who makes AMG 102?

AMG 102 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is an investigational small molecule in the oncology therapeutic area.

What phase is AMG 102 in?

AMG 102 is in clinical development, with completed trials in Phase 1 and Phase 2. It is an investigational drug and has not been approved by the FDA. Its development includes studies in various cancer types.

What clinical trials is AMG 102 in?

AMG 102 has been studied in several completed clinical trials. NCT00770848 tested it with mitoxantrone and prednisone in castrate-resistant prostate cancer. NCT01113398 evaluated it with Avastin for recurrent malignant glioma. NCT01233687 studied it with erlotinib for advanced non-small-cell lung cancer.

Is AMG 102 the same as rilotumumab?

AMG 102 is also known as rilotumumab, a monoclonal antibody targeting hepatocyte growth factor. It has been investigated in oncology clinical trials for various solid tumors, including glioblastoma and non-small-cell lung cancer.