A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Negative Gastroesophageal Cancer
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Onartuzumab (MetMAb)
Oxaliplatin
Folinic acid
Levofolinic acid
5-Fluorouracil
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Onartuzumab (MetMAb) with mFOLFOX6
Placebo with mFOLFOX6
Arm Description
Onartuzumab (MetMAb) in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid [leucovorin], and oxaliplatin)
Placebo in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid [leucovorin], and oxaliplatin)
Outcomes
Primary Outcome Measures
Progression-free survival (PFS) in all patients
Progression-free survival (PFS) in patients with Met-positive tumors
Secondary Outcome Measures
Safety: incidence of adverse events
Overall survival (OS)
Overall response rate (ORR)
Duration of response (DOR)
Full Information
NCT ID
NCT01590719
First Posted
May 2, 2012
Last Updated
August 4, 2016
Sponsor
Hoffmann-La Roche
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01590719
Brief Title
A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Negative Gastroesophageal Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Genentech, Inc.
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Onartuzumab (MetMAb) with mFOLFOX6
Arm Type
Experimental
Arm Description
Onartuzumab (MetMAb) in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid [leucovorin], and oxaliplatin)
Arm Title
Placebo with mFOLFOX6
Arm Type
Placebo Comparator
Arm Description
Placebo in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid [leucovorin], and oxaliplatin)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Intervention Type
Drug
Intervention Name(s)
Onartuzumab (MetMAb)
Intervention Description
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin 85 mg/m2 IV every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Intervention Type
Drug
Intervention Name(s)
Folinic acid
Intervention Description
Folinic acid 400 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Intervention Type
Drug
Intervention Name(s)
Levofolinic acid
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) in all patients
Time Frame
Up to 18 months
Title
Progression-free survival (PFS) in patients with Met-positive tumors
Time Frame
Up to 18 months
Secondary Outcome Measure Information:
Title
Safety: incidence of adverse events
Time Frame
18 months
Title
Overall survival (OS)
Time Frame
18 months
Title
Overall response rate (ORR)
Time Frame
18 months
Title
Duration of response (DOR)
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
City
Garland
State/Province
Texas
ZIP/Postal Code
77060
Country
United States
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
VIC 3165
Country
Australia
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
City
Tainan
ZIP/Postal Code
00704
Country
Taiwan
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Taoyuan County
ZIP/Postal Code
333
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
27401892
Citation
Shah MA, Cho JY, Tan IB, Tebbutt NC, Yen CJ, Kang A, Shames DS, Bu L, Kang YK. A Randomized Phase II Study of FOLFOX With or Without the MET Inhibitor Onartuzumab in Advanced Adenocarcinoma of the Stomach and Gastroesophageal Junction. Oncologist. 2016 Sep;21(9):1085-90. doi: 10.1634/theoncologist.2016-0038. Epub 2016 Jul 8.
Results Reference
derived
Learn more about this trial
A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Negative Gastroesophageal Cancer
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