Clinical trial NCT02137343: A Phase 3 Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Gastric Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Gastric Cancer
First Line Treatment Gastroesophageal Junction (GEJ)
Gastroesophageal Junction Cancer (GEJ)
GEJ Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-05-13
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: 4 years
measure: Overall Survival
timeFrame: 4 years
Secondary outcomes:
measure: TTP
timeFrame: 4 years
measure: ORR
timeFrame: 4 years
measure: DCR
timeFrame: 4 years
measure: TTR
timeFrame: 4 years
measure: Incidence of subject adverse events, laboratory abnormalities and immunogenicity
timeFrame: 4 years
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Research Site
state: Aichi
city: Chiba-shi
country: Japan
facility: Research Site
state: Chiba
city: Kashiwa-shi
country: Japan
facility: Research Site
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Research Site
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Akashi-shi
country: Japan
facility: Research Site
state: Hyogo
city: Kawasaki-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Research Site
state: Osaka
city: Suita-shi
country: Japan
facility: Research Site
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Research Site
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Research Site
state: Saitama
city: Suntou-gun
country: Japan
facility: Research Site
state: Shizuoka
city: Utsunomiya-shi
country: Japan
facility: Research Site
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Goyang-si, Gyeonggi-do
country: Korea, Republic of
facility: Research Site
city: Hwasun
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: