PMID- 21156020
OWN - NLM
STAT- MEDLINE
DCOM- 20111031
LR  - 20191210
IS  - 1464-410X (Electronic)
IS  - 1464-4096 (Linking)
VI  - 108
IP  - 5
DP  - 2011 Sep
TI  - A phase II study of the efficacy and safety of AMG 102 in patients with 
      metastatic renal cell carcinoma.
PG  - 679-86
LID - 10.1111/j.1464-410X.2010.09947.x [doi]
AB  - OBJECTIVE: * To evaluate the efficacy and safety of single-agent AMG 102, an 
      investigational, fully human monoclonal antibody to hepatocyte growth 
      factor/scatter factor (HGF/SF), in renal cell carcinoma (RCC). PATIENTS AND 
      METHODS: * This open-label phase II study included patients >/= 18 years old with 
      histologically confirmed, advanced or metastatic RCC (mRCC) and Eastern 
      Cooperative Oncology Group performance status 0 to 2. AMG 102 was administered 
      i.v. at 10 or 20 mg/kg once every 2 weeks. * A two-stage design was used at each 
      dose level and the primary endpoint was objective best confirmed response (by 
      Response Evaluation Criteria in Solid Tumours) at any time. RESULTS: * Sixty-one 
      patients with mRCC enrolled and received AMG 102 (40 at 10 mg/kg; 21 at 20 
      mg/kg). Overall, 70.5% were men, median age was 59 years (range, 39 to 84 years), 
      and 92% had received previous anti-vascular endothelial growth factor therapy. 
      RCC histologies were: clear cell (75.4%), papillary (11.5%), chromophobe (4.9%) 
      and unclassified (8.2%). * One confirmed partial response occurred at 10 mg/kg, 
      maintained for over 2.5 years; 26 patients (43%) had stable disease, 10 (16%) for 
      >/= 32 weeks. The median profression-free survival was 3.7 months at 10 mg/kg and 
      2.0 months at 20 mg/kg. The commonest adverse events were oedema (45.9%), fatigue 
      (37.7%) and nausea (27.9%). Grade 3 or 4 adverse events occurred in 33% of 
      patients, the most common being oedema (9.8%). * Baseline levels of plasma HGF/SF 
      and soluble c-Met as well as archival-tumour c-Met did not correlate with 
      measures of efficacy. CONCLUSION: * Single-agent AMG 102 was tolerable, but it is 
      unclear if AMG 102 was growth inhibitory in this population of patients with 
      mRCC.
CI  - (c) 2010 BJU INTERNATIONAL. NO CLAIM TO ORIGINAL US GOVERNMENT WORKS.
FAU - Schoffski, Patrick
AU  - Schoffski P
AD  - Department of General Medical Oncology, University Hospitals Leuven, Leuven 
      Cancer Institute, Catholic University Leuven, Leuven, Belgium. 
      patrick.schoffski@uz.kuleuven.be
FAU - Garcia, Jorge A
AU  - Garcia JA
FAU - Stadler, Walter M
AU  - Stadler WM
FAU - Gil, Thierry
AU  - Gil T
FAU - Jonasch, Eric
AU  - Jonasch E
FAU - Tagawa, Scott T
AU  - Tagawa ST
FAU - Smitt, Melanie
AU  - Smitt M
FAU - Yang, Xinqun
AU  - Yang X
FAU - Oliner, Kelly S
AU  - Oliner KS
FAU - Anderson, Abraham
AU  - Anderson A
FAU - Zhu, Min
AU  - Zhu M
FAU - Kabbinavar, Fairooz
AU  - Kabbinavar F
LA  - eng
SI  - ClinicalTrials.gov/NCT00422019
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20101213
PL  - England
TA  - BJU Int
JT  - BJU international
JID - 100886721
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Biomarkers, Tumor)
RN  - 0 (HGF protein, human)
RN  - 51WEW898IJ (rilotumumab)
RN  - 67256-21-7 (Hepatocyte Growth Factor)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal/administration & dosage/adverse effects/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Biomarkers, Tumor/*blood
MH  - Carcinoma, Renal Cell/*drug therapy/mortality/secondary
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Hepatocyte Growth Factor/blood
MH  - Humans
MH  - Infusions, Intravenous
MH  - Kidney Neoplasms/*drug therapy/mortality/secondary
MH  - Male
MH  - Middle Aged
MH  - Survival Analysis
MH  - Treatment Outcome
EDAT- 2010/12/16 06:00
MHDA- 2011/11/01 06:00
CRDT- 2010/12/16 06:00
PHST- 2010/12/16 06:00 [entrez]
PHST- 2010/12/16 06:00 [pubmed]
PHST- 2011/11/01 06:00 [medline]
AID - 10.1111/j.1464-410X.2010.09947.x [doi]
PST - ppublish
SO  - BJU Int. 2011 Sep;108(5):679-86. doi: 10.1111/j.1464-410X.2010.09947.x. Epub 2010 
      Dec 13.