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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01590719




Registration number
NCT01590719
Ethics application status
Date submitted
2/05/2012
Date registered
3/05/2012
Date last updated
9/08/2016

Titles & IDs
Public title
A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Negative Gastroesophageal Cancer
Scientific 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
Secondary ID [1] 0 0
2012-000858-57
Secondary ID [2] 0 0
YO28252
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Onartuzumab (MetMAb)
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Folinic acid
Treatment: Drugs - Levofolinic acid
Treatment: Drugs - 5-Fluorouracil

Experimental: Onartuzumab (MetMAb) with mFOLFOX6 - Onartuzumab (MetMAb) in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid \[leucovorin\], and oxaliplatin)

Placebo comparator: Placebo with mFOLFOX6 - Placebo in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid \[leucovorin\], and oxaliplatin)


Treatment: Drugs: Placebo
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment

Treatment: Drugs: Onartuzumab (MetMAb)
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment

Treatment: Drugs: Oxaliplatin
Oxaliplatin 85 mg/m2 IV every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment

Treatment: Drugs: Folinic acid
Folinic acid 400 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment

Treatment: Drugs: 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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) in all patients
Timepoint [1] 0 0
Up to 18 months
Primary outcome [2] 0 0
Progression-free survival (PFS) in patients with Met-positive tumors
Timepoint [2] 0 0
Up to 18 months
Secondary outcome [1] 0 0
Safety: incidence of adverse events
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Overall survival (OS)
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
Overall response rate (ORR)
Timepoint [3] 0 0
18 months
Secondary outcome [4] 0 0
Duration of response (DOR)
Timepoint [4] 0 0
18 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2014
Sample size
Target
Accrual to date
Final
123
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Sydney
Recruitment hospital [2] 0 0
- Herston
Recruitment hospital [3] 0 0
- Woodville South
Recruitment hospital [4] 0 0
- East Bentleigh
Recruitment hospital [5] 0 0
- Heidelberg
Recruitment hospital [6] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Sydney
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment postcode(s) [4] 0 0
VIC 3165 - East Bentleigh
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
Singapore
State/province [12] 0 0
Singapore
Country [13] 0 0
Taiwan
State/province [13] 0 0
Tainan
Country [14] 0 0
Taiwan
State/province [14] 0 0
Taipei
Country [15] 0 0
Taiwan
State/province [15] 0 0
Taoyuan County
Country [16] 0 0
Thailand
State/province [16] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Genentech, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01590719