Clinical trial NCT01590719: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2012-05-03
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression-free survival (PFS) in all patients
timeFrame: Up to 18 months
measure: Progression-free survival (PFS) in patients with Met-positive tumors
timeFrame: Up to 18 months
Secondary outcomes:
measure: Safety: incidence of adverse events
timeFrame: 18 months
measure: Overall survival (OS)
timeFrame: 18 months
measure: Overall response rate (ORR)
timeFrame: 18 months
measure: Duration of response (DOR)
timeFrame: 18 months
Other outcomes:
Locations:
city: Denver
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Fort Myers
country: United States
state: Florida
city: St Petersburg
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Niles
country: United States
state: Illinois
city: Albany
country: United States
state: New York
city: New York
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Bedford
country: United States
state: Texas
city: Garland
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Vancouver
country: United States
state: Washington
city: Sydney
country: Australia
state: New South Wales
city: Herston
country: Australia
state: Queensland
city: Woodville South
country: Australia
state: South Australia
city: East Bentleigh
country: Australia
state: Victoria
city: Heidelberg
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan County
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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.