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A Randomized, Phase II, 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 Gastroesophageal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

Thank you

Trial Information

A Randomized, Phase II, 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 Gastroesophageal Cancer


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 (if unknown)

- Radiographic evidence of disease; 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 other 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) in all patients

Outcome Time Frame:

Up to 18 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

YO28252

NCT ID:

NCT01590719

Start Date:

July 2012

Completion Date:

August 2014

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
McLean, Virginia  22101
Denver, Colorado