HGF and c-Met Targeted Drug Development for Oncology

The table below lists clinical trials for cancer therapeutics targeting the hepatocyte growth factor (HGF)/Met signaling pathway. This page is maintained by Don Bottaro in the Urologic Oncology Branch, CCR/NCI, and should be cited as:

Cecchi F, Wright C, Bottaro DP. Experimental Cancer Therapeutics Targeting the Hepatocyte Growth Factor/Met Signaling Pathway. Center for Cancer Research, National Cancer Institute, Bethesda, MD 20892 USA. URL: https://ccrod.cancer.gov/confluence/display/CCRHGF/Home

The original source for this page was published in the May 2010 issue of European Journal of Cancer, vol 7, pp 1260-70.

Each of the column headings (Drug, Design, Phase, etc.) can be toggled to reorder the entire list by the column content.

UCSD Signaling Gateway

Additional information on the HGF/Met signaling pathway can be found on the University of California San Diego (UCSD) Signaling Gateway

Drug

Design

Phase

Status

Patient Population

Combinations

Clinical Trial

Results

Rilotumumab (AMG 102)

Safety

Ib/II

Completed

Non-Small Cell Lung Cancer (NSCLC)

Cisplatin/Etoposide

NCT00791154

 

Rilotumumab (AMG 102)

Safety/Efficacy

I/II

Completed

Metastatic Colorectal Cancer (mCRC), wild type KRAS

Panitumumab

NCT00788957

 

Rilotumumab (AMG 102)

Safety/Efficacy

I/II

Completed 

Castration-Resistant Prostate Cancer (CRPC)

Mitoxantrone/Prednisone

NCT00770848

 

Rilotumumab (AMG 102)

Safety/Efficacy

II

Completed

Renal Cell Carcinoma (RCC)

 

NCT00422019

BJU Int 2011

Rilotumumab (AMG 102)

Safety/Efficacy

II

Active, not recruiting

Advanced Malignant Glioma

 

NCT00427440

Neuro Oncol 2011

Rilotumumab (AMG 102)

Safety/Efficacy

I/II

Completed

Locally Advanced/Metastatic Gastric or Esophagogastric Junction (EGJ) Adenocarcinoma

Capecitabine/Epirubicin/Cisplatin (ECX)

NCT00719550

ASCO 2012
ESMO 2012a
ESMO 2012b

Rilotumumab (AMG 102)

Safety

I/II

Recruiting

NSCLC

Erlotinib

NCT01233687

 

Rilotumumab (AMG 102)

Safety/Efficacy

II

Completed

Recurrent Malignant Glioma

Bevacizumab 

NCT01113398

ASCO 2012

NCT01113398

Rilotumumab (AMG 102)

Efficacy

II

Recruiting

Advanced Gastroesophageal Adenocarcinoma

Folinic Acid/5-Fluorouracil/Oxaliplatin (FOLFOX)

NCT01443065

 

Rilotumumab (AMG 102)

Safety

II

Completed

Persistent/Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

 

NCT01039207

 

Rilotumumab (AMG 102)

Treatment

II

Withdrawn

Malignant Mesothelioma

Pemetrexed Disodium and Cisplatin

NCT01105390

 

Rilotumumab (AMG 102)

Efficacy

III

Terminated

Locally Advanced/MetastaticGastric or Esophagogastric Junction (EGJ) Adenocarcinoma

Randomized vs placebo

NCT01697072

ASCO 2013

Rilotumumab (AMG 102)Safety/EfficacyI/IbCompletedJapanese Subjects with Advanced Solid Tumors or Advanced or Metastatic Gastric or GEJ NCT01791374 
Rilotumumab (AMG 102)EfficacyIIITerminatedGastric Cancer+ Cisplatin and Capecitabine vs placeboNCT02137343 

Onartuzumab (MetMAb)

Safety

I

Completed

Advanced Solid Malignancies

Bevacizumab 

NCT01068977

AACR 2010

ASCO 2010

EMSO 2010

AACR 2011

Onartuzumab (MetMAb)

Efficacy

II

Active, results reported 

NSCLC

Erlotinib

NCT00854308

ClinicalTrials.gov

JCO 2013

Onartuzumab (MetMAb)

Efficacy

II

Completed

Metastatic/Recurrent, Triple-Negative Breast Cancer

Bevacizumab and Paclitaxel

NCT01186991

Anal Oncol 2015

Onartuzumab (MetMAb)

Efficacy

II

Active, not recruiting

mCRC

FOLFOX/Bevacizumab

NCT01418222

ASCO 2012

Onartuzumab (MetMAb)

Safety/Efficacy

II

Active, not recruiting

NSCLC

Bevacizumab/Platinum/Paclitaxel and Pemetrexed/Platinum

NCT01496742

EMSO 2012

Onartuzumab (MetMAb)

Safety/Efficacy

II

Active, not recruiting

NSCLC

Paclitaxel/Platinum

NCT01519804

EMSO 2012

Onartuzumab (MetMAb)

Safety/Efficacy

II

Not yet recruiting

Gastric cancer

mFOLFOX6

NCT01590719

 

Onartuzumab (MetMAb)

Safety/Efficacy

III

Recruiting

NSCLC

Tarceva (Erlotinib)

NCT01456325

Press Release

Onartuzumab (MetMAb)

Safety/Efficacy

II

Recruiting

Recurrent Glioblastoma

+Bevacizumab vs Bevacizumab alone vs Onartuzumab monotherapy, Randomized

NCT01632228

 

Onartuzumab (MetMAb)

Safety/Efficacy

III

Recruiting

Metastatic Gastric cancer, HER2-, Met+

mFOLFOX6

NCT01662869

ASCO 2013

Onartuzumab (MetMAb)Safety/PKIbRecruitingAdvanced Solid Malignancies+Vemurafenib, +Cobimetinib, +Vemurafenib and CobimetinibNCT01974258 
Onartuzumab (MetMAb)Safety/EfficacyIRecruitingChinese Patients with Locally Advanced or Metastatic Solid Tumors NCT02031731 
Onartuzumab (MetMAb)Safety/PKIbRecruitingAdvanced HCCalone or +SorafenibNCT01897038 
Onartuzumab (MetMAb)Safety/EfficacyIIIRecruitingMet+, Stage IIIb or IV NSCLC with Activating EGFR Mutation+ErlotinibNCT01887886 
Onartuzumab (MetMAb)EfficacyIIIRecruitingMet+, Incurable Stage IIIb or IV NSCLC+ErlotinibNCT02031744 

Ficlatuzumab (AV-299)

Safety/Efficacy

I

Terminated

Glioblastoma

 

NCT01189513

 

Ficlatuzumab (AV-299)

Safety/Tolerability

I

Completed

Advanced/Metastatic Solid Malignancies

 

NCT00969410

EMSO 2012

Clin Cancer Res 2014

Ficlatuzumab (AV-299)

Safety/Efficacy

I/II

Completed

NSCLC

Gefitinib

NCT01039948

EMSO 2010

Ficlatuzumab (AV-299)

Safety

I

Active

Relapsed/Refractory Solid Malignancies

Erlotinib

NCT00725634

 

Ficlatuzumab (AV-299)Safety/EfficacyIActive, not recruiting

Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

+CetuximabNCT02277197 
Ficlatuzumab (AV-299)Safety/EfficacyITerminated

Ficlatuzumab, Cisplatin and IMRT in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

+Cisplatin +Intensity Modulated RadiotherapyNCT02277184 
SAIT301SafetyIRecruiting

Subjects With Advanced c-MET Positive (+) Solid Tumors Followed by Expansion in Selected Tumor Types

 NCT02296879 

TAK-701 (HuL2G7)

Safety/Tolerability/Pharmacokinetics

I

Completed

Non-Hematologic Malignancies

 

NCT00831896

 

AMG 337

Safety

I

Recruiting

Advanced Solid Malignancies

 

NCT01253707

 

AMG 337EfficacyIINot yet recruitingMET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors NCT02016534 
AMG 337Safety/EfficacyI/IIRecruitingAdvanced solid tumor (Pahse I) Gastric/Esophageal Adenocarcinoma or Other Solid Tumor (Phase II) NCT02096666 
AMG 337Safety/EfficacyI/IINot yet recruitingAdvanced Stomach or Esophageal Cancer

Fluorouracil, Oxaliplatin, Leucovorin

NCT02344810 

AMG 208

Safety

I

Active, not recruiting

Advanced Solid Malignancies

 

NCT00813384

J Clin Oncol 2014

Tivantinib (ARQ 197)

Notice

Safety/Efficacy

I

Completed

Advanced Solid Malignancies

 

NCT00612209

J Clin Oncol 2011

Tivantinib (ARQ 197)

Notice

Bio-availability

I

Completed

Advanced Solid Malignancies

 

NCT01149720

 

Tivantinib (ARQ 197)

Notice

Safety/Efficacy

II

Completed

Gastric Cancer (GC)

 

NCT01152645

 

Tivantinib (ARQ 197)

Notice

Safety/Efficacy

I/II

Active, not recruiting

CRC, wild type KRAS

Irinotecan/Cetuximab

NCT01075048

ASCO 2013

Tivantinib (ARQ 197)

Notice

Safety/Efficacy

II

Active, not recruiting

Advanced/Metastatic NSCLC, KRAS mutation +

Erlotinib

NCT01395758

 

Tivantinib (ARQ 197)

Notice

Safety

I

Completed

Advanced Solid Malignancies

Gemcitabine

NCT00874042

EMSO 2012

Tivantinib (ARQ 197)

Notice

Safety/Efficacy

II

Completed 

Hepatocellular Carcinoma (HCC)

 

NCT00988741

ASCO 2012
EMSO 2012a
EMSO 2012b

Lancet Oncol 2013

Tivantinib (ARQ 197)

Notice

Safety

I

Active, not recruiting

Advanced Solid Malignancies

Sorafenib

NCT00827177

EMSO 2012

Tivantinib (ARQ 197)

Notice

Pharmacokinetics

I

Completed

Healthy Volunteer

 

NCT00651638

 

Tivantinib (ARQ 197)

Notice

Safety

I

Completed

NSCLC

Erlotinib

NCT01251796

EMSO 2012

Tivantinib (ARQ 197)

Notice

Safety

I

Completed

Advanced/Recurrent NSCLC

Erlotinib

NCT01069757

 

Tivantinib (ARQ 197)

Notice

Safety/Efficacy

III

Active, not recruiting

Non-Squamous NSCLC

Erlotinib

NCT01244191

Clin Lung Cancer 2012

Tivantinib (ARQ 197)

Notice

Safety/Tolerability

I

Completed

Metastatic Solid Malignancies

 

NCT00302172

EMSO 2012

Clin Can Res 2011

Tivantinib (ARQ 197)

Notice

Efficacy

II

Completed

Unresectable Locally Advanced/Metastatic Pancreatic Adenocarcinoma

Gemcitabine

NCT00558207

 

Tivantinib (ARQ 197)

Notice

Safety/Efficacy

I

Completed

Advanced Solid Malignancies

Erlotinib

NCT00612703

EMSO 2012

Cancer 2012

Tivantinib (ARQ 197)

Notice

Efficacy

II

Withdrawn

Locally Advanced/Metastatic GC

Oxaliplatin/Capecitabine/Irinotecan

NCT01070290

 

Tivantinib (ARQ 197)

Notice

Safety

I

Recruiting

Advanced Solid Malignancies

Pazopanib

NCT01468922

 

Tivantinib (ARQ 197)

Notice

Safety

I

Completed 

HCC (Cirrhotic Patients)

Erlotinib

NCT00802555

Br J Cancer 2013

Tivantinib (ARQ 197)

Notice

Efficacy

II

Completed

Advanced/Metastatic NSCLC

Erlotinib

NCT00777309

J Clin Oncol 2011

Tivantinib (ARQ 197)

Notice

Pharmacokinetics

I

Completed

Healthy Volunteer

 

NCT00658554

 

Tivantinib (ARQ 197)

Notice

Safety/Tolerability

I

Completed 

Advanced Solid/Recurrent Malignancies

 

NCT00609921

Ann Oncol 2013

Tivantinib (ARQ 197)

Notice

Efficacy

III

Active, not recruiting 

Advanced/Metastatic Non Squamous NSCLC wild type EGFR

Erlotinib

NCT01377376

 

Tivantinib (ARQ 197)

Notice

Safety/Efficacy

II

Completed

Refractory Germ Cell Tumors

 

NCT01055067

Invest New Drugs 2013

Tivantinib (ARQ 197)

Notice

Safety/Efficacy

I/II

Recruiting

Extension Protocol; Subjects Who Were Previously Enrolled in Other ARQ 197 Studies

 

NCT01178411

 

Tivantinib (ARQ 197)

Notice

Safety/Efficacy

II

Completed

Microphthalmia Transcription Factor-Associated Tumors (MiT) Associated with Renal Cell Carcinoma (RCC)/Alveolar Soft Part Sarcoma (ASPS)/Clear Cell Carcinoma (CCS)

 

NCT00557609

Cancer 2012

Tivantinib (ARQ 197)

Notice

Safety/Efficacy

II

Active, not recruiting

Relapsed Multiple Myeloma

 

NCT01447914

 

Tivantinib (ARQ 197)

Notice

Safety/Efficacy

II

Active, not recruiting

Advanced or Metastatic EGFR mutation-positive NSCLC

Erlotinib

NCT01580735

 

Tivantinib (ARQ 197)

Notice

Pharmacokinetics

I

Completed

Solid Tumors

Omeprazole, s-Warfarin, Caffeine, Midazolam, Digoxin

NCT01517399

 

Tivantinib (ARQ 197)

Notice

Treatment

II

Completed

Recurrent or Metastatic Breast Cancer

 

NCT01575522

NCT01575522

Tivantinib (ARQ 197)

Notice

Treatment

II

Recruiting

Metastatic Prostate Cancer

 

NCT01519414

 

Tivantinib (ARQ 197)

Notice

Efficacy

I/II

Recruiting

Advanced Solid Tumors, First Line Metastatic Gastroesophageal Cancer

FOLFOX

NCT01611857

ASCO 2013

Tivantinib (ARQ 197)

Notice

Efficacy

II

Completed

Triple Negative Breast cancer

 

NCT01542996

NCT01542996

Tivantinib (ARQ 197)

Notice

Safety

I

Completed

Effect of Tivantinib on QTC Interval in Cancer Subjects

 

NCT01699061

 

Tivantinib (ARQ 197)

Notice

Safety

I

Recruiting

Younger Patients with Relapsed or Refractory Solid Tumors

 

NCT01725191

 

Tivantinib (ARQ 197)

Notice

Efficacy

II

Recruiting

Metastatic or Recurrent or Inoperable Squamous Cell Carcinoma of the Head and Neck (SCCHN)

+ Cetuximab vs Cetuximab, Randomized

NCT01696955

 

Tivantinib (ARQ 197)

Notice

Safety

I

Recruiting

Metastatic or Unresectable Solid Tumors

Temsirolimus

NCT01625156

 

Tivantinib (ARQ 197)

Notice

Efficacy

II

Suspended

Metastatic or Locally Advanced Unresectable RCC

Erlotinib

NCT01688973

 

Tivantinib (ARQ 197)

Notice

Safety/Efficacy

I

Recruiting

Advanced or Metastatic Solid Tumors or Recurrent Small Cell Lung Cancer

Topotecan

NCT01654965

 

Tivantinib (ARQ 197)

Notice

Safety

I

Recruiting

Advanced HCC

 

NCT01656265

 

Tivantinib (ARQ 197)

Notice
EfficacyIIIRecruitingHepatocellular Carcinoma NCT01755767ASCO 2013

Tivantinib (ARQ 197)

Notice
EfficacyIIRecruitingEGFR-Inhbitor Resistant, KRAS-Wildtype Advanced or Metastatic Colorectal Cancer+CetuximabNCT01892527 

Tivantinib (ARQ 197)

Notice
SafetyIRecruitingMetastatic or Unresectable Solid Tumors+BevacizumabNCT01749384 

Tivantinib (ARQ 197)

Notice
EfficacyIIRecruitingPatients with Previously Treated Mesothelioma NCT01861301 

Tivantinib (ARQ 197)

Notice
EfficacyIIIRecruitingMet+ Inoperable HCC with One Prior Sorafenib Therapy NCT02029157 

BMS-777607
(ASLAN002)

Safety/EfficacyI/II

Completed

Advanced/Metastatic Solid Malignancies, CRPC, Squamous Cell Carcinoma of the Head and Neck (SCCHN), Papillary Renal-Cell Carcinoma (PRCC)

 

NCT00605618

 

BMS-777607
(ASLAN002)

Safety

I

Recruiting

Advanced or Metastatic Solid Tumors

 

NCT01721148

 

Golvatinib

 E7050

Efficacy

I/II

Recruiting

Advanced Solid Malignancies, Glioblastoma, Unresectable Stage III/IV Melanoma

Lenvatinib

NCT01433991

 

Golvatinib

 E7050

 

Safety/Efficacy

 

I

 

Recruiting

 

Solid Tumors

 NCT01428141 

Golvatinib

 E7050

 

Safety/Efficacy

 

I/II

 

Terminated

 

Advanced or Metastatic Solid Tumors & Previously Untreated Gastric Cancer (GC)

 

with Cisplatin  Capecitabine vs Cisplatin  Capecitabine alone,
Randomized

 

NCT01355302

 

Golvatinib

 E7050

 

Safety/Efficacy

 

I/II

 

Completed

 

Advanced Solid Tumors

  

NCT00921869

 

Golvatinib

 E7050

 

Safety/Efficacy

 

I/II

 

Active, not recruiting

 

Platinum-Resistant SCCHN

 

Cetuximab vs Cetuximab alone, Randomized

 

NCT01332266

 

Golvatinib

 E7050

 

Safety/Efficacy

 

I/II

 

Recruiting

 

HCC

 

Sorafenib vs Sorafenib alone, Randomized

 

NCT01271504

 

Golvatinib

 E7050

 

Safety

 

I

 

Completed

 

Advanced Solid Tumors

  

NCT00869895

ASCO 2012

EMD1214063

Safety

I

Completed

Advanced Solid Malignancies

 

NCT01014936

EMSO 2012

ASCO 2013

EMD1204831

Safety

I

Terminated

Advanced Solid Malignancies

 

NCT01110083

ASCO 2012

Foretinib (GSK1363089)

Safety/Efficacy

II

Completed

Recurrent/Metastatic SCCHN

 

NCT00725764

 

Foretinib (GSK1363089)

Safety

I

Completed

Advanced Solid Malignancies

 

NCT00743067

Clin Can Res 2010

Foretinib (GSK1363089)

Safety/Efficacy

II

Completed

Metastatic Gastric Carcinoma (mGC)

 

NCT00725712

 

Foretinib (GSK1363089)

Bio-availability

I

Completed

Advanced Solid Malignancies

 

NCT00742261

 

Foretinib (GSK1363089)

Safety/Efficacy

I

Active, not recruiting

HCC

 

NCT00920192

 

Foretinib (GSK1363089)

Safety/Efficacy

II

Completed

PRCC

 

NCT00726323

ASCO 2012

J Clin Oncol 2012

Foretinib (GSK1363089)

Safety/Efficacy

I/II

Active, not recruiting

Locally Advanced/Metastatic NSCLC

Erlotinib

NCT01068587

 

Foretinib (GSK1363089)

Safety/Efficacy

I/II

Active, not recruiting

HER2 Over-Expressing Metastatic Breast Cancer

Lapatinib

NCT01138384

 

Foretinib (GSK1363089)

Safety/Efficacy

II

Completed

ER, PR and HER2 negative Breast Cancer

 

NCT01147484

ASCO 2012

Foretinib (GSK1363089)SafetyICompletedSolid Tumors NCT00742131 
Foretinib (GSK1363089)EfficacyIINot yet openGenomic Subpopulations of NSCLC NCT02034097 

INCB28060
(INC280)

Safety/Tolerability

I

Active, Not Recruiting

Advanced Solid Malignancies

 

NCT01072266

ASCO 2011

INCB28060
(INC280)

Treatment

I

Recruiting

Solid tumors

 

NCT01324479

 

INCB28060
(INC280)

Safety

I

Recruiting

Japanese Patients with Advanced Solid Tumors

 

NCT01546428

 

INCB28060
(INC280)

Safety/Efficacy

IB/II

Active, Not Recruiting

NSCLC, EGFR-mutated, c-MET-amplified, EGFR-inhibitor insensitive

Gefitinib

NCT01610336

 

INCB28060
(INC280)

Safety/Tolerability

I

Recruiting

c-MET Dependent Advanced Solid Tumors

 

NCT01324479

 

INCB28060
(INC280)
Safety/EfficacyIIRecruitingAdvanced HCC With c-MET Dysregulation NCT01737827ASCO 2015
INCB28060
(INC280)
Safety/EfficacyIb/IIRecruitingRecurrent Glioblastoma+BuparlisibNCT01870726 
INCB28060
(INC280)
Safety EfficacyIISuspendedAdvanced HCC After Progression or Sorafenib Intolerance NCT01964235 
INCB28060
(INC280)
SafetyIRecruitingMet+ NSCLC+ErlotinibNCT01911507 
INCB28060
(INC280)
EfficacyIIRecruitingPapillary RCC NCT02019693 
INCB28060
(INC280)
Safety/EfficacyIINot yet RecruitingChinese Patients with Advanced NSCLCmulti-arm + AUY922, BYL719, LDK378, MEK162NCT02276027 
INCB28060
(INC280)
EfficacyIIRecruitingAdvanced NSCLC Patients that have Received 1 or 2 Prior Lines of Therapy NCT02414139 
NCB28060
(INC280)
 Safety/Pharmacokinetics/EfficacyI/IIRecruitingSquamous Cell Carcinoma of Head and Neck (Phase I)
Metastatic Colorectal Cancer (Phase II)
 CetuximabNCT02205398 
NCB28060
(INC280)
Drug-drug Interaction: Pharmacokinetics of Midazolam and CaffieneINot yet RecruitingPatients with Met-dysregulated Advanced Solid TumorsMidazolam, CaffieneNCT02520752 
NCB28060
(INC280)
Drug-drug Interaction: Pharmacokinetics of Digoxin and RosuvastatinINot yet RecruitingPatients with Met-dysregulated Advanced Solid TumorsDigoxin, RosuvastatinNCT02626234 

LY2801653

Safety/Tolerability

I

Recruiting

Advanced and/or Metastatic Cancer

 

NCT01285037

Invest New Drugs 2013

LY2801653PK/radiolabeledICompletedHealthy Participants NCT01981408 

MK8033

Safety

I

Completed

Advanced Solid Malignancies

Omeprazole

NCT00559182

 

Amuvatinib (MP470)

Safety

I

Completed

Advanced Solid Malignancies

 

NCT00894894

Cancer Chemother Pharmacol 2013

Amuvatinib (MP470)

Safety/Efficacy

I

Completed

Advanced Solid Malignancies

Topotecan/Docetaxel/Erlotinib/Paclitaxel/
Carboplatin/Etoposide

NCT00881166

 

Amuvatinib (MP470)

Efficacy

II

Active, not recruiting

SCLC

Platinum/Etoposide

NCT01357395

Press Release

Amuvatinib (MP470)

Safety/PK/Pharmacodynamics

I

Terminated
prior to activation

Metastatic Solid Malignancies/Lymphoma

 

NCT00504205

 

MGCD265

Safety/Efficacy

I/II

Recruiting

Advanced Malignancies/NSCLC

Erlotinib/Docetaxel

NCT00975767

 

MGCD265

Safety

I

Recruiting

Advanced Solid Malignancies

 

NCT00697632

 

MGCD265

Safety

I

Completed

Advanced Solid Malignancies

 

NCT00679133

 

MGCD265SafetyICompletedHealthy Subjects in Fasting State NCT01930006 

MK2461

Safety/Efficacy

I/II

Completed

Advanced Solid Malignancies

 

NCT00496353

 

MK2461

Safety

I

Completed

Advanced Solid Malignancies

 

NCT00518739

ASCO 2008

Crizotinib (PF02341066) **

PK

I

Completed 

Subjects With Impaired Renal Function

 

NCT01419041

 

Crizotinib (PF02341066) **

Safety/PK/PD

I

Withdrawn
prior to activation 

Advanced Solid Malignancies

VEGF Inhibitor Combinations

NCT01441388

 

Crizotinib (PF02341066) **

Safety/Efficacy

IB

Recruiting

Anaplastic Lymphoma Kinase (ALK+) Tumors

 

NCT01121588

 

Crizotinib (PF02341066) **

PK

I

Completed, results reported 

Japanese Healthy Male Volunteers

 

NCT01250730

ClinicalTrials.gov

Crizotinib (PF02341066) **

PK

I

Completed, results reported 

Healthy Volunteer

 

NCT01297595

ClinicalTrials.gov

Crizotinib (PF02341066) **

Safety/Efficacy

I/II

Active, not recruiting

NSCLC

Erlotinib

NCT00965731

ASCO 2012

Crizotinib (PF02341066) **

PK

I

Completed, results reported

Healthy Volunteer

 

NCT01168934

ClinicalTrials.gov

Crizotinib (PF02341066) **

Safety/Efficacy

I

Completed, results reported

NSCLC

Dacomitinib 

NCT01121575

ClinicalTrials.gov

Crizotinib (PF02341066) **

PK - [14C]PF 02341066

I

Completed, results reported

Healthy Male Volunteer

 

NCT01082380

ClinicalTrials.gov

Crizotinib (PF02341066) **

PK

I

Completed, results reported 

Healthy Volunteer

Ketoconazole

NCT01149785

ClinicalTrials.gov

Crizotinib (PF02341066) **

PK

I

Completed, results reported 

Healthy Volunteer

Rifampin

NCT01147055

ClinicalTrials.gov

Crizotinib (PF02341066) **

PK

I

Completed, results reported 

Healthy Volunteer

 

NCT01154218

ClinicalTrials.gov

Crizotinib (PF02341066) **

Safety

I

Recruiting

Advanced Solid Malignancies

 

NCT00585195

ASCO 2013

ASCO 2013

New Engl J Med 2010

Lancet Oncol 2011

J Clin Oncol 2011

Lancet Oncol 2012

Crizotinib (PF02341066) **

Safety/Efficacy

III

Completed

NSCLC, ALK+

Pemetrexed/Docetaxel

NCT00932893

ASCO 2013

ASCO 2013

New Engl J Med 2013

NCT00932893

Crizotinib (PF02341066) **

Safety/PK

I/II

Recruiting

Relapsed/Refractory Solid Malignancies or Anaplastic Large Cell Lymphoma (Young Population)

 

NCT00939770

Lancet Oncol 2013

Crizotinib (PF02341066) **

Safety/Efficacy

II

Recruiting

NSCLC, ALK+

 

NCT00932451

Expert Rev Anticancer Ther 2012

Crizotinib (PF02341066) **

Bioavailability

I

Completed, results reported 

Healthy Volunteer

 

NCT00939731

ClinicalTrials.gov

Crizotinib (PF02341066) **

Taste Assessment

I

Completed

Healthy Volunteer

 

NCT01125904

 

Crizotinib (PF02341066) **

Safety

I

Recruiting

NSCLC

Dacomitinib

NCT01441128

 

Crizotinib (PF02341066) **

Obtain tissue specimens to identify molecular determinants of acquired resistance

 

Recruiting

NSCLC, ALK+

 

NCT01300429

 

Crizotinib (PF02341066) **

Safety/Efficacy

III

Recruiting

Recurrent/Metastatic Non-Squamous Cell Carcinoma of the Lung ALK+

 

NCT01154140

Expert Rev Anticancer Ther 2012

Crizotinib (PF02341066) **

Safety/Efficacy

I/II

Active, Not recruiting

NSCLC

Erlotinib

NCT00965731

NCT00965731

Crizotinib (PF02341066) **

Safety/Efficacy

I

Recruiting

Advanced Malignancies

Pemetrexed or Pazopanib

NCT01548144

 

Crizotinib (PF02341066) **

PK

I

Completed

Healthy Volunteers

Esomeprazole

NCT01549574

 

Crizotinib (PF02341066) **

PK

I

Recruiting

Advanced Cancer Patients with Hepatic Impairment

 

NCT01576406

 

Crizotinib (PF02341066) **

Safety/Efficacy

I/II

Recruiting

NSCLC

HSP90 Inhibitor AT13387

NCT01712217

 

Crizotinib (PF02341066) **

Safety/Efficacy

II

Recruiting

Altered ALK and/or MET in Locally Advanced and/or Metastatic Anaplastic Large Cell Lymphoma, Inflammatory Myfibroblastic Tumor, PRCC Type 1, Alveolar Soft Part Sarcoma, Clear Cell Sarcoma, Alveolar Rhabdomyosarcoma

 

NCT01524926

 

Crizotinib (PF02341066) **

Safety/Tolerability

I

Not Yet Recruiting

Younger Patients with Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma

Cyclophosphamide, Dexrazoxane, Doxorubicin, Topotecan, Vincristine

NCT01606878

 

Crizotinib (PF02341066) **

Safety/Efficacy

I

Recruiting

Diffuse Intrinsic Pontine Glioma, High Grade Glioma, Pediatric

Dasatinib

NCT01644773

 

Crizotinib (PF02341066) **

Surveillance

IV

Invitation Only

Regulatory Post Marketing Commitment Plan

 

NCT01597258

 

Crizotinib (PF02341066) **

Safety/Efficacy

I

Recruiting

Advanced Malignancies

VemurafenibSorafenib

NCT01531361

 

Crizotinib (PF02341066) **Safety/EfficacyIIRecruitingMet-positive Gastric Adenocarcinoma as Third-line Therapy NCT02435108 
Crizotinib (PF02341066) **Safety/EfficacyIIRecruitingMet or Ron-positive Metastatic Urothelial Cancer NCT02612194 
Crizotinib (PF02341066) **EfficacyIIRecruiting

Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) That Has Progressed After Crizotinib

+ Pemetrexed DisodiumNCT02134912 
Crizotinib (PF02341066) **SafetyIRecruitingAdvanced Solid Tumors+ axitinibNCT01999972 

PF-04217903

Safety/Efficacy

I

Completed, results reported

Advanced Solid Malignancies

 

NCT00706355

ClinicalTrials.gov

Cabozantinib (XL184)

Cometriq

Safety/Efficacy

II

Active, not recruiting

mCRPC

 

NCT01428219

ASCO 2013

Cabozantinib (XL184)

Cometriq

Safety/Efficacy

II

Recruiting 

Carcinoid/Pancreatic Neuroendocrine Tumor

 

NCT01466036

 

Cabozantinib (XL184)

Cometriq

Efficacy

II

Recruiting

Breast Cancer, ER+/PR+and HER2-

 

NCT01441947

 

Cabozantinib (XL184)

Cometriq

Safety/Efficacy

I

Completed

mCRPC

 

NCT01347788

 

Cabozantinib (XL184)

Cometriq

Safety

I

Completed 

Advanced Solid Malignancies

 

NCT00215605

ASCO 2013

J Clin Oncol 2011

Cabozantinib (XL184)

Cometriq

Randomized Discontinuation Trial

II

Completed

Advanced Solid Malignancies

 

NCT00940225

ASCO 2013

ASCO 2013

J Clin Oncol 2013

Cabozantinib (XL184)

Cometriq

Efficacy

III

Active, not recruiting

Metastatic Medullary Thyroid Cancer (MTC)

 

NCT00704730

ASCO 2012
EMSO 2012

ASCO 2013

J Clin Oncol 2013

NCT Results

Cabozantinib (XL184)

Cometriq

Safety/Efficacy

II

Completed

Glioblastoma Multiforme

 

NCT00704288

 

Cabozantinib (XL184)

Cometriq

Safety/Efficacy

I/II

Completed

NSCLC

Erlotinib

NCT00596648

 

Cabozantinib (XL184)

Cometriq

Drug-Drug Interaction Safety Study

I

Completed

Advanced Solid Malignancies

Rosiglitazone

NCT01100619

 

Cabozantinib (XL184)

Cometriq

Safety

I

Completed

Glioblastoma

Temozolomide/Radiation Therapy

NCT00960492

 

Cabozantinib (XL184)

Cometriq

Safety/Efficacy

II

Completed

Grade IV Astrocytic Tumor

 

NCT01068782

 

Cabozantinib (XL184)

Cometriq

Safety

I

Completed

Advanced/Metastatic Solid Malignancies (Japanese population)

 

NCT01018745

 

Cabozantinib (XL184)

Cometriq

Safety/Efficacy

I

Recruiting

Multiple Myeloma with Bone Disease

 

NCT01582295

 

Cabozantinib (XL184)

Cometriq

Efficacy

I

Active, not recruiting

Post-Chemo Castration-Resistant Prostate Cancer

Abiraterone

NCT01574937

 

Cabozantinib (XL184)

Cometriq

Efficacy

II

Active, not recruiting

Castration-Resistant Prostate Cancer with Bone Metastases

 

NCT01599793

ASCO 2012
EMSO 2012

Cabozantinib (XL184)

Cometriq

Safety/Pharmacokinetics

I

Completed

Hepatic Impaired Adult Subjects

 

NCT01493869

 

Cabozantinib (XL184)

Cometriq

Safety/Efficacy

III

Active, not Recruiting

Metastatic Castration-Resistant Prostate Cancer Previously Treated with Docetaxel and Abiraterone or MDV3100

Prednisone

NCT01605227

Press Release 2014

Cabozantinib (XL184)

Cometriq

Safety

I

Active, not recruiting

Japanese Subjects with Advanced Cancer

 

NCT01553656

EMSO 2012

Cabozantinib (XL184)

Cometriq

Safety/Efficacy

III

Terminated

Previously Treated, Symptomatic Castration-Resistant Prostate Cancer

Mitoxantrone/Prednisone

NCT01522443

Press Release 2014

Cabozantinib (XL184)

Cometriq

Efficacy

II

Suspended

Solid tumors

 

NCT01588821

 

Cabozantinib (XL184)

Cometriq

Safety/Efficacy

II

Recruiting

Androgen-Dependent Metastatic Prostate Cancer

Androgen Ablation Therapy

NCT01630590

 

Cabozantinib (XL184)

Cometriq

Safety/Efficacy

II

Recruiting

Advanced NSCLC, KIF5B/RET+

 

NCT01639508

ASCO 2013

Cancer Discov 2013

Cabozantinib (XL184)

Cometriq

Efficacy

II

Active, not recruiting

Stage IV NSCLC, EGFR Wild-Type

Erlotinib

NCT01708954

 

Cabozantinib (XL184)

Cometriq

Efficacy

 

Recruiting

CRPC

 

NCT01703065

 

Cabozantinib (XL184)

Cometriq

Efficacy

II

Active, not recruiting

Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube, or Peritoneal Cancer

Randomized vs Paclitaxel

NCT01716715

 

Cabozantinib (XL184)

Cometriq

Expanded Access

 

Approved for marketing

Medullary Thyroid Cancer (MTC)

 

NCT01683110

 

Cabozantinib (XL184)

Cometriq

Efficacy

II

Recruiting

Advanced Urothelial Cancer

 

NCT01688999

ASCO 2013

Cabozantinib (XL184)

Cometriq

Safety

I

Recruiting

Advanced Prostate Cancer

DocetaxelPrednisone

NCT01683994

ASCO 2013

Cabozantinib (XL184)

Cometriq

Safety/EfficacyIICompletedMetastatic Triple Negative Breast Cancer NCT01738438 

Cabozantinib (XL184)

Cometriq

Safety/EfficacyIIIRecruitingSubjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib Randomized vs placeboNCT01908426 

Cabozantinib (XL184)

Cometriq

EfficacyIIRecruitingAdults with Advanced Soft Tissue Sarcoma NCT01755195 

Cabozantinib (XL184)

Cometriq

Safety/EfficacyIIIActive, not recruitingSubjects with Metastatic Renal Cell CarcinomaRandomized vs EverolimusNCT01865747 

Cabozantinib (XL184)

Cometriq

EfficacyIIRecruitingCastrate Resistant Prostate Cancer with Visceral Metastases NCT01834651 

MSC2156119J

same as:

EMD1214063

Safety/EfficacyICompletedSolid Tumors NCT01832506 
MSC2156119JSafetyIRecruitingAdvanced Solid Tumors 

NCT01014936

 
MSC2156119JSafety/EfficacyI/IIRecruitingAdvanced NSCLC+GefitinibNCT01982955 
MSC2156119JSafety/EfficacyI/IIRecruitingAsian Subjects with HCCvs SorafenibNCT01988493 
MSC2156119JSafety/EfficacyI/IIRecruitingSecond-Line HCC 

NCT02115373

 
LY2875358EfficacyIIRecruitingGastric Cancer NCT01874938

ASCO 2013

LY2875358SafetyIRecruitingAdvanced Cancer NCT01287546 
LY2875358EfficacyIIRecruitingNSCLCErlotinibNCT01900652 
LY2875358Safety/EfficacyI/IIRecruitingAdvanced CancerRamucirumabNCT02082210 
LY2875358SafetyIRecruitingJapanese Participants with Advanced Cancer

alone, +Erlotinib, or +Gefitinib

NCT01602289 
LY2875358EfficacyIIRecruitingNSCLC with activating EGFR mutationsErlotinibNCT01897480 
SAR125844SafetyICompletedAdvanced Malignant Solid Tumors with MET Amplification and Phospho-Met Positive Tumors Without MET Amplification NCT01391533 
SAR125844Safety/Efficacy/PharmacodynamicsICompletedAsian Advanced Malignant Solid Tumor Patients NCT01657214 

Volitinib Savolitinib

AZD6094

HMPL-504

HMP-504

 

Safety/PharmacokineticsIRecruitingAdvanced Solid Tumors NCT01773018 

Volitinib Savolitinib

AZD6094

HMPL-504

HMP-504

Safety/PharmacodynamicsINot Yet RecruitingRas Wild-Type Colorectal CancerPart 2 of study: CetuximabNCT02630420 

Volitinib Savolitinib

AZD6094

HMPL-504

HMP-504

Safety/EfficacyIIOngoing, Not RecruitingPapillary Renal Cell Cancer NCT02127710 

Volitinib Savolitinib

AZD6094

HMPL-504

HMP-504

Safety/EfficacyIbRecruitingEGFR Mutation Positive Advanced Lung CancerAZD9291NCT02143466 

Volitinib Savolitinib

AZD6094

HMPL-504

HMP-504

Safety/EfficacyIINot Yet RecruitingAdvanced Gastric Adenocarcinoma Patients with MET Overexpression as a Second-line TreatmentDocetaxelNCT02447380 

Volitinib Savolitinib

AZD6094

HMPL-504

HMP-504

Safety/EfficacyIb/IIRecruitingPhase 1b in Any Solid Cancer and Sequential Phase II in Advanced Gastric Adenocarcinoma Patients with MET Amplification as a Second Line TreatmentDocetaxelNCT02447406 

Volitinib Savolitinib

AZD6094

HMPL-504

HMP-504

Safety/Pharmacokinetics/Preliminary Efficacy1bRecruitingEGFR Mutation Positive NSCLC Patients that Progressed on EGFR TKI TreatmentGefitinibNCT02374645 

Volitinib Savolitinib

AZD6094

HMPL-504

HMP-504

Safety/EfficacyIIRecruitingAdvanced Gastric Adenocarcinoma Patients with MET Amplification as a Third-line Treatment NCT02449551 

Volitinib Savolitinib

AZD6094

HMPL-504

HMP-504

Safety/EfficacyIIRecruiting

Locally Advanced or Metastatic Kidney Cancer

Randomized Muti-Arm Study Comparing Cabozantinib, Crizotinib, Volitinib or SunitinibNCT02761057 
Met RNA CAR T cellsSafety/EfficacyIRecruitingMetastatic Breast Cancer
Triple Negative Breast Cancer
 NCT01837602 

**Trials listed here are for cancers where activation of the HGF/Met signaling pathway is indicated. Crizotinib (PF02341066) also potently inhibits anaplastic lymphoma kinase (Alk), and several trials currently underway are specific for tumors where Alk is activated. Crizotinib clinical trials where Alk activation is a criterion for eligibility are not included here.

HGF/Met Clinical Trial Metrics:

Agents

28

Trials

229

 

Active

137

Recruiting

90

Closed

78

Reporting

75

Last updated by Fox, Susan (NIH/NCI) [E] on Mar 05, 2018