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Oncology

Our Clinical Trials

AMG 780 (angiopoietin inhibitor)

Research Area Description Phase Status NCT/Amgen ID*

Solid TumorsAMG 780 First-In-Human Study in Adult Subjects with Advanced Solid Tumors 1

01137552 20070879

Trebananib (AMG 386) (angiopoietin inhibitor)


BreastTrebananib With Paclitaxel and Trastuzumab or Capecitabine and Lapatinib in HER2-Positive 1b

00807859 20062042

BreastTrebananib Plus Paclitaxel With or Without Bevacizumab as First-Line in HER2-Negative 2

00511459 20060341

Colorectal Trebananib in Combination With FOLFIRI 200752570 20070307

Gastric, Esophageal

Trebananib in Combination With Cisplatin & Capecitabine 2

00583674 20060439

HepaticFirst-line Therapy of Trebananib in Combination With Sorafenib 2

00872014 20080580

NSCLCTrebananib with Pemetrexed and Carboplatin in NSCLC 1b/2

01666977 20101128

OvarianOpen-Label First-line Therapy of Trebananib With Paclitaxel and Carboplatin 1b

01253681 20090155

OvarianTrebananib in Combination With Pegylated Liposomal Doxorubicin or Topotecan 1b

00770536 20070182

OvarianTRINOVA-1: Trebananib in Combination With Paclitaxel in Recurrent Ovarian Cancer 3

01204749 20090508

OvarianTRINOVA-3: Trebananib in Combination With Paclitaxel/Carboplatin in First-Line Therapy 3

01493505 20101129

Renal Trebananib in Combination With Sunitinib 200853372 20080579

Solid TumorsTrebananib Pharmacokinetics in Cancer Subjects With Normal and Impaired Renal Function

10133194120090277

Solid TumorsTrebananib With Either Motesanib, Bevacizumab, Sorafenib, or Sunitinib 1b

00861419 20050170

ANGIOGENESIS ANTIBODY DRUG CONJUGATE, continued

Active, not recruiting Active, recruiting

AMG 172 (antibody drug conjugate)


RenalFirst-in-Human Study of AMG 172 in Patients with Kidney Cancer 1

0149782120090515

ANTIBODY DRUG CONJUGATE

AMG 900 (pan-Aurora kinase inhibitor)


LeukemiaAMG 900 in Adult Subjects With Acute Leukemias and Related Disorders 1

01380756 20101351

Solid TumorsAMG 900 First-In-Human Study in AdultSubjects With Advanced Solid Tumors 1

0085837720080016

CELL CYCLE

Denosumab (RANK ligand inhibitor)


BreastDenosumab Study in Adjuvant Breast Cancer (D-CARE) 3

0107715420060359

BreastPlacebo-Controlled Study of Denosumab in Patients Receiving Aromatase Inhibitor Therapy 3

00556374 20050209

Giant Cell Tumor

Denosumab in Recurrent or Unresectable Giant Cell Tumor of the Bone 2

00680992 20062004

Multiple Myeloma

Denosumab Compared to Zoledronic Acid for Treatment of Bone Disease in Multiple Myeloma 3

01345019 20090482

ProstateDenosumab Study on Lens Opacifications in Non-Metastatic Patients on ADT 3

00925600 20080560

Solid Tumors and Multiple Myeloma

Denosumab in the Treatment of Hypercalcemia of Malignancy 2

00896454 20070315

BONE METASTASES AND METABOLISM

AMG 595 (anti-EGFRvIII)


Glioma First-In-Human Study of AMG 595 10147500620090505

GROWTH REGULATIONRilotumumab (HGF/SF inhibitor)


ColorectalRilotumumab or Ganitumab in Combination With Panitumumab 1b/2

00788957 20060447

Gastric, Esophageal

Rilotumumab in Combination With Epirubicin, Cisplatin, and Capecitabine 1b/2

00719550 20060317

Gastric, Esophageal

RILOMET-1: Rilotumumab with ECX in First-Line Treatment for MET-Positive Gastric, Lower Esophageal, or GEJ Adenocarcinoma

30169707220070622

ProstateRilotumumab in Combination With Mitoxantrone and Prednisone 1b/2

00770848 20070611

SCLCRilotumumab or Ganitumab in Combination With Cisplatin or Carboplatin, and Etoposide 1b/2

00791154 20060534

AMG 319 (PI3Kδ inhibitor)


LymphomaAMG 319 First-in-Human Study in Adult Subjects with Lymphoid Malignancy 1

0130002620101262

AMG 337 (MET inhibitor)


Solid Tumors First-in-Human Study of AMG 337 10125370720101132

Ganitumab (IGF1R antagonist)


ColorectalPanitumumab Plus Irinotecan Followed by Panitumumab Plus Ganitumab 2

00891930 20070820

SCLCGanitumab or Rilotumumab (AMG 102) in Combination With Cisplatin or Carboplatin, and Etoposide

1b/200791154 20060534

HEMATOPOIESISDarbepoetin alfa (erythropoiesis-stimulating agent)


MDSDarbepoetin alfa for the Treatment of Anemic Subjects With Low or Intermediate-1 Risk MDS 3

0136214020090160

NSCLCImpact of Darbepoetin alfa on Survival in Anemic Subjects Receiving Chemotherapy 3

00858364 20070782

GROWTH REGULATION, continued

Panitumumab (EGFR inhibitor)


ColorectalSPIRITT: Second-line Therapy of Panitumumab or Bevacizumab in Combination With FOLFIRI 2

00418938 20060141

ColorectalPEAK: First-line Therapy of Panitumumab or Bevacizumab in Combination With mFOLFOX6 2

0081978020070509

ColorectalPanitumumab Plus Irinotecan Followed by Panitumumab Plus Ganitumab (AMG 479) 2

00891930 20070820

ColorectalPanitumumab With Best Supportive Care (BSC) vs BSC Alone 3

01412957 20100007

ColorectalASPECCT: Panitumumab Efficacy and Safety Compared to Cetuximab in Subjects With WT KRAS mCRC

301001377 20080763

Head & NeckPRISM: Second-line Therapy With Panitumumab 2

00446446 20062088

Head & NeckCONCERT2: Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy 2

00547157 20062079

Head & NeckPARTNER: Cisplatin and Docetaxel With or Without Panitumumab 2

0045477920050236

Head & NeckPharmacokinetic Study of Chemotherapy With or Without Panitumumab 2

0075644420080008

Panitumumab (EGFR inhibitor), continued


Solid Tumors Panitumumab Pediatric Study 100658658 20050252

GROWTH REGULATION, continued

Other Clinical Trials


FN

Study to Investigate the Relationship Between Physician-Assessed Febrile Neutropenia (FN) Risk Probability Score and Prediction Tool FN Risk Probability Score for Patients With Non-Myeloid Malignancies

n/a—

20090344

Romiplostim (thrombopoiesis stimulator)


ITPInterventional Study in Adult Subjects with ITP Receiving Romiplostim 2

01143038 20080435

ITPLong-term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects With ITP 3

01071954 20090340

ITPSafety and Efficacy Study of Romiplostim to Treat ITP in Pediatric Subjects 3

0144441720080279

MDSPlacebo-Controlled Study of Romiplostim(All subjects have been removed from treatment and are being followed for observation)

20061452320060198

AMG 208 (MET inhibitor)


Solid Tumors First-In-Human Study of AMG 208 100813384 20080895


Pegfilgrastim (granulocyte colony-stimulating factor)


BreastNOLAN: The Effect of Prophylactic Naproxen or Loratidine on Bone Pain with Chemotherapy and Pegfilgrastim

20171200920110147

Breast RIAN: The Effect of Patient Education on Reported Bone Pain with Chemotherapy and Pegfilgrastim 2

—20110148

Colorectal PAVES: Placebo-Controlled Study of Pegfilgrastim With Bevacizumab and Either FOLFOX or FOLFIRI 3

0091117020080259

Amgen aspires to be the best human therapeutics company. Amgen is committed to developing new therapies to treat serious illnesses — a long and careful process. Among the most important steps in this process are the clinical trials, where people volunteer to receive an experimental new drug or procedure and be observed for its effects.

At Amgen, we apply four guiding principles to our research and development efforts.

� The first is to focus on grievous illness. Given the difficulty of successfully developing a new therapy, we focus our efforts on developing therapies to help patients suffering from the greatest unmet medical needs.

�Our second guiding principle is to be modality independent. Small molecules and biotherapeutics (biologics) each have unique and inherent advantages and disadvantages. Our modality independent approach allows us to leverage the advantageous aspects of a particular approach that are best suited to interdict a disease.

�Our third major emphasis is to study disease in patients. While it is significantly more complicated to study disease in humans, we believe that this is the only way to successfully develop human therapeutics.

�Our fourth guiding principle, seamless integration, informs everything we do. There are important insights that come to basic research and clinical development from understanding the medical marketplace, and vice versa. Aligning our priorities across these functions ensures that we develop potential therapeutics in a manner that will address unmet medical needs and meet the changing demands of the marketplace.

Amgen’s Research and Development Vision

IMMUNOTHERAPY

TUMOR ASSOCIATED MACROPHAGESAMG 820 (c-fms inhibitor)


Solid Tumors First-in-Human Study of AMG 820 101444404 20060347

Talimogene Laherparepvec† (oncolytic immunotherapy)


Melanoma OPTiM‡: Talimogene Laherparepvec† Compared to GM-CSF in Unresectable Melanoma 3

00769704 —

Information as of 11/09/12. Statements are based on the company’s current beliefs and Amgen disclaims any duty to update. For more information about Amgen and its business, including risks and uncertainties, please refer to Amgen’s filings with the SEC. Products under investigational study have not been approved by the FDA for the use under investigation. This information is provided only for purposes of providing general information on clinical trials and stages of development on the select candidates identified. This information should not be construed as a recommendation for use of any product for unapproved uses.

*For more detailed information about the trial, visit www.clinicaltrials.gov or www.amgentrials.com.†Previously referred to as OncoVEXGM-CSF

‡OPTiM = OncoVEXGM-CSF Pivotal Trial In Melanoma.

Blinatumomab (bispecific T cell engager antibody)


LeukemiaBlinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia

1b/201471782

—

LeukemiaBlinatumomab in Patients With Minimal Residual Disease of B-Precursor Acute Lymphoblastic Leukemia

201207388

—

LeukemiaBlinatumomab in Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia

201466179

—

LeukemiaBlinatumomab in Adult Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia

201209286

—

Non-Hodgkin’s Lymphoma

Safety Study of Blinatumomab in Patients With Relapsed NHL 1

00274742 —


our clinical trials - amgen · pdf fileamg 319 (pi3kδ inhibitor) research area...

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