A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic HER2-Negative Gastroesophageal Cancer - Full Text View

Purpose

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

Condition	Intervention	Phase
Gastric Cancer	Drug: onartuzumab Drug: Placebo Drug: mFOLFOX6	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Fluorouracil Leucovorin calcium Levoleucovorin

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Progression-free survival (PFS) in all patients [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
Progression-free survival (PFS) in patients with Met-positive tumors [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety: incidence of adverse events [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Overall survival (OS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Overall response rate (ORR) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Duration of response (DOR) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	July 2012
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Onartuzumab Arm	Drug: onartuzumab Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment\n Drug: mFOLFOX6 Oxaliplatin 85 mg/m2 IV, folinic acid 400 mg/m2 or levofolinic acid 200 mg/m2, 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
Placebo Comparator: Placebo Arm	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 levofolinic acid 200 mg/m2, 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

Arms

Assigned Interventions

Experimental: Onartuzumab Arm

Drug: onartuzumab

Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment\n

Drug: mFOLFOX6

Oxaliplatin 85 mg/m2 IV, folinic acid 400 mg/m2 or levofolinic acid 200 mg/m2, 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

Placebo Comparator: Placebo Arm

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 levofolinic acid 200 mg/m2, 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590719

Contacts

Contact: Please reference Study ID Number: YO28252 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Show 36 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Genentech

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01590719 History of Changes
Other Study ID Numbers:	YO28252, 2012-000858-57
Study First Received:	May 2, 2012
Last Updated:	May 13, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Fluorouracil
Leucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013