A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Negative Gastroesophageal Cancer

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590719
• Other study ID #: YO28252
• Secondary ID: 2012-000858-57
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2012
• Last updated: August 4, 2016
• Start date: July 2012
• Est. completion date: October 2014

Study information

• Verified date: August 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• Eastern Cooperative Oncology Group (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 hepatocyte growth factor (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

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Placebo
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
• Onartuzumab (MetMAb)
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
• Oxaliplatin
Oxaliplatin 85 mg/m2 IV every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
• Folinic acid
Folinic acid 400 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
• Levofolinic acid
If folinic acid is unavailable: levofolinic acid 200 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
• 5-Fluorouracil
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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Korea, Republic of,  Singapore,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS) in all patients		Up to 18 months	No
Primary	Progression-free survival (PFS) in patients with Met-positive tumors		Up to 18 months	No
Secondary	Safety: incidence of adverse events		18 months	No
Secondary	Overall survival (OS)		18 months	No
Secondary	Overall response rate (ORR)		18 months	No
Secondary	Duration of response (DOR)		18 months	No