A Phase 3 Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Gastric Cancer

Gastric Cancer Clinical Trial

— RILOMET-2  

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02137343
• Other study ID #: 20120142
• Status: Terminated
• Phase: Phase 3
• First received: April 28, 2014
• Last updated: January 18, 2016
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices AgencySouth Korea: Korea Food and Drug Administration (KFDA)China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo controlled study of Rilotumumab (AMG 102) with Cisplatin and Capecitabine (CX) for untreated advanced mesenchymal epithelial transition factor (MET)-positive gastric or gastroesophageal junction adenocarcinoma (GEJ).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 100 Years

Eligibility

Key Inclusion Criteria:

• Pathologically confirmed unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma.

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

• Tumor MET-positive by immunohistochemistry (IHC).

• Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

• Male or female subject greater than or equal to 20 years of age at the time of informed consent.

Key Exclusion Criteria:

• Human epidermal growth factor receptor 2 (HER2)-overexpressing locally advanced or metastatic gastric or GEJ adenocarcinoma.

• Previous systemic therapy for locally advanced or metastatic gastric or GEJ or lower esophageal adenocarcinoma.

• Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy to randomization.

• Squamous cell histology.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Rilotumumab
Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter factor (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/SF/MET-driven activities in cells.
• Placebo
Placebo
• Cisplatin
A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death)
• Capecitabine
A chemo-therapy prodrug that is enzymatically converted to 5-fluorouracil in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.

Locations

Country	Name	City	State
Japan	Research Site	Akashi-shi	Hyogo
Japan	Research Site	Bunkyo-ku	Tokyo
Japan	Research Site	Chiba-shi	Chiba
Japan	Research Site	Fukuoka-shi	Fukuoka
Japan	Research Site	Kashiwa-shi	Chiba
Japan	Research Site	Kawasaki-shi	Kanagawa
Japan	Research Site	Kitaadachi-gun	Saitama
Japan	Research Site	Matsuyama-shi	Ehime
Japan	Research Site	Nagoya-shi	Aichi
Japan	Research Site	Osaka-shi	Osaka
Japan	Research Site	Osaka-shi	Osaka
Japan	Research Site	Osakasayama-shi	Osaka
Japan	Research Site	Sapporo-shi	Hokkaido
Japan	Research Site	Suita-shi	Osaka
Japan	Research Site	Suntou-gun	Shizuoka
Japan	Research Site	Takatsuki-shi	Osaka
Japan	Research Site	Utsunomiya-shi	Tochigi
Korea, Republic of	Research Site	Goyang-si, Gyeonggi-do
Korea, Republic of	Research Site	Hwasun
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	To determine if the treatment of rilotumumab in combination with CX significantly improves progression-free survival as compared with rilotumumab-placebo in combination with CX in subjects with unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma with MET-positive expression.	4 years	Yes
Primary	Overall Survival	To determine if the treatment of rilotumumab in combination with CX significantly improves overall survival as compared with rilotumumab-placebo in combination with CX in subjects with unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma with MET-positive expression.	4 years	Yes
Secondary	TTP	Time to Progression (TTP)	4 years	Yes
Secondary	ORR	Objective Response Rate	4 years	Yes
Secondary	DCR	Disease Control Rate	4 years	Yes
Secondary	TTR	Time to Response	4 years	Yes
Secondary	Incidence of subject adverse events, laboratory abnormalities and immunogenicity	Adverse events and laboratory abnormalities are reported by Common Terminology Criteria for Adverse Events (CTCAE) (v3.0)	4 years	Yes

External Links

•   AmgenTrials clinical trials website