or
forgot password

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG102) With Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

Thank you

Trial Information

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG102) With Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma


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)

- Evaluable (measurable or non-measurable) disease by Response Evaluation Criteria In
Solid Tumors (RECIST) 1.1 criteria

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 adenocarcinoma

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

- Previous treatment with anthracyclines must not exceed total cumulative dose of
epirubicin of 400 mg/m2

- Squamous cell histology

- Left ventricular ejection fraction (LVEF) < 50%

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival

Outcome Description:

To determine if the treatment of rilotumumab in combination with ECX significantly improves overall survival in subjects with unresectable locally advanced or metastatic MET positive gastric or GEJ cancer

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20070622

NCT ID:

NCT01697072

Start Date:

October 2012

Completion Date:

December 2016

Related Keywords:

  • Gastric Cancer
  • Gastric Cancer
  • First Line Treatment Gastroesophageal Junction (GEJ)
  • Gastroesophageal Junction Cancer (GEJ)
  • GEJ Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

Name

Location
Research Site Mesa, Arizona  
Research Site Boulder, Colorado  
Research Site Arlington Heights, Illinois  
Research Site Baltimore, Maryland  
Research Site Alexandria, Minnesota  
Research Site Las Vegas, Nevada  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Allentown, Pennsylvania  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas