A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic HER2-Negative And Met-Positive Gastroesophageal Cancer (MetGastric)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01662869
First received: August 8, 2012
Last updated: July 28, 2014
Last verified: July 2014

August 8, 2012
July 28, 2014
November 2012
August 2015   (final data collection date for primary outcome measure)
  • Overall survival (OS) in the Met IHC 2+/3+ patient subgroup [ Time Frame: Approximately 38 months ] [ Designated as safety issue: No ]
  • Overall survival in the intent-to-treat population [ Time Frame: Approximately 38 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01662869 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: Approximately 38 months ] [ Designated as safety issue: No ]
  • Overall response rate (ORR) [ Time Frame: Approximately 38 months ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: Approximately 38 months ] [ Designated as safety issue: No ]
  • European Organization for Research and Treatment Cancer - Quality of life questionnaire [ Time Frame: Approximately 38 months ] [ Designated as safety issue: No ]
  • European Organization for Research and Treatment Cancer - Gastric cancer-specific quality of life questionnaire [ Time Frame: Approximately 38 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic HER2-Negative And Met-Positive Gastroesophageal Cancer (MetGastric)
A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating The Efficacy And Safety Of Onartuzumab (MetMAb) In Combination With 5-Fluorouracil, Folinic Acid, And Oxaliplatin (mFOLFOX6) In Patients With Metastatic Her2-Negative, Met-Positive Gastroesophageal Cancer (MetGastric)

This randomized, multicenter, double-blind, placebo-controlled study will evalua te the efficacy and safety of onartuzumab (MetMAb) in combination with mFOLFOX6 in patients with metastatic HER2-negative and Met-positive adenocarcinoma of the stomach or gastroesophageal junction. Patients will be randomized in a 1:1 rati

o to receive either onartuzumab (MetMAb) or placebo in combination with mFOLFOX6 Patients may continue to receive onartuzumab (MetMAb) or placebo until disease progression, unacceptable toxicity, patient or physician decision to discontinu e treatment.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Gastric Cancer
  • Drug: Onartuzumab
    Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
  • Drug: Placebo
    Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
  • Drug: mFOLFOX6
    Oxaliplatin 85 mg/m2 IV, folinic acid 400 mg/m2 (or as deemed appropriate per investigator),or levofolinic acid 200 mg/m2 (or as deemed appropriate per investigator), 5-fluorouracil 400 mg/m2 IV followed by 2400 mg/m2 IV infusion every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
  • Experimental: Onartuzumab Arm
    Interventions:
    • Drug: Onartuzumab
    • Drug: mFOLFOX6
  • Placebo Comparator: Placebo Arm
    Interventions:
    • Drug: Placebo
    • Drug: mFOLFOX6
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
August 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, 18 years of age and older
  • Adenocarcinoma of the stomach or gastroesophageal junction with inoperable, metastatic disease, not amenable for curative therapy
  • ECOG performance status 0 or 1
  • Life expectancy >3 months
  • Presence of tissue sample for immunohistochemistry assay of Met receptor and HER2 status
  • Tumor (primary or metastatic lesion) defined as Met-positive by immunohistochemistry
  • Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1); Patients with peritoneal disease would generally be regarded as having evaluable disease and allowed to enter the trial.
  • For women who are not postmenopausal or surgically sterile; agreement to use an adequate method of contraception (e.g., hormonal implant) during the treatment period and for at least 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin
  • For men: agreement to use a barrier method of contraception during the treatment period and for 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin
  • Adequate laboratory values

Exclusion Criteria:

  • HER2-positive tumor (primary tumor or metastasis)
  • Previous chemotherapy for locally advanced or metastatic gastric carcinoma (adjuvant or neoadjuvant chemotherapy must be completed at least 6 months prior to randomization)
  • Prior treatment with investigational drugs that target the HGF or Met pathway
  • History of another malignancy within the previous 5 years, except for appropriately treated and presumed cured carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, and localized prostate cancer
  • Receipt of an investigational drug within 28 days prior to study start
  • Clinically significant gastrointestinal abnormalities, except from gastric cancer (e.g., Crohn's disease)
  • Significant history of cardiac disease
  • Significant vascular disease
  • Infection with human immunodeficiency virus, hepatitis B, or hepatitis C
Both
18 Years and older
No
Contact: Reference Study ID Number: YO28322 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Australia,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Guatemala,   Hong Kong,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Panama,   Poland,   Russian Federation,   Singapore,   Spain,   Switzerland,   Taiwan,   Thailand,   Turkey,   United Kingdom
 
NCT01662869
YO28322, 2012-001402-23
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Genentech
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP