Gastric CancerPhase 2NCT01590719
A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Negative Gastroesophageal Cancer
A Phase 2 study testing Onartuzumab (MetMAb), Oxaliplatin and Folinic acid in people with Gastric Cancer, run by Hoffmann-La Roche at 36 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Onartuzumab (MetMAb), Oxaliplatin and Folinic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 36 sitesin 6 countries
- Study dates
- Jul 2012to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- Significant history of cardiac disease
- Significant vascular disease
- Infection with human immunodeficiency virus, hepatitis B, or hepatitis C
Trial locations and contacts
36 sites in 6 countries.
36 sites in 6 countries
United States18 sites
Study site
Albany, New York, 12206
Study site
Austin, Texas, 78731
Study site
Bedford, Texas, 76022
Study site
Chicago, Illinois, 60637
Study site
Cincinnati, Ohio, 45219
Study site
Denver, Colorado, 80218
Study site
Fairfax, Virginia, 22031
Study site
Fort Myers, Florida, 33908
Study site
Garland, Texas, 77060
Study site
Nashville, Tennessee, 37203
Study site
New Haven, Connecticut, 06520
Study site
New York, New York, 10065
Study site
Niles, Illinois, 60714
Study site
Richmond, Virginia, 23226
Study site
St. Petersburg, Florida, 33705
Study site
The Woodlands, Texas, 77380
Study site
Tyler, Texas, 75702
Study site
Vancouver, Washington, 98684
Australia6 sites
Study site
East Bentleigh, Victoria, VIC 3165
Study site
Heidelberg, Victoria, 3084
Study site
Herston, Queensland, 4029
Study site
Nedlands, Western Australia, 6009
Study site
Sydney, New South Wales, 2139
Study site
Woodville South, South Australia, 5011
Taiwan4 sites
Study site
Tainan, 00704
Study site
Taipei, 00112
Study site
Taipei, 100
Study site
Taoyuan County, 333
South Korea3 sites
Study site
Seoul, 05505
Study site
Seoul, 06351
Study site
Seoul, 135-720
Thailand3 sites
Study site
Bangkok, 10330
Study site
Bangkok, 10400
Study site
Bangkok, 10700
About this study
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
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.
- Conditions
- Gastric Cancer
- Being tested
- Placebo, Onartuzumab (MetMAb), Oxaliplatin, Folinic acid, Levofolinic acid
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Onartuzumab (MetMAb)Drug
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
OxaliplatinDrug
Oxaliplatin 85 mg/m2 IV every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Folinic acidDrug
Folinic acid 400 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Levofolinic acidDrug
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-FluorouracilDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Onartuzumab (MetMAb) with mFOLFOX6 | Experimental | Onartuzumab (MetMAb) in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid [leucovorin], and oxaliplatin) Receives: Drug: Onartuzumab (MetMAb); Drug: Oxaliplatin; Drug: Folinic acid; Drug: Levofolinic acid; Drug: 5-Fluorouracil |
| Placebo with mFOLFOX6 | Placebo comparator | Placebo in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid [leucovorin], and oxaliplatin) Receives: Drug: Placebo; Drug: Oxaliplatin; Drug: Folinic acid; Drug: Levofolinic acid; Drug: 5-Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) in all patients
Measured: Up to 18 months
Progression-free survival (PFS) in patients with Met-positive tumors
Measured: Up to 18 months
Secondary outcomes (4)
Safety: incidence of adverse events
Measured: 18 months
Overall survival (OS)
Measured: 18 months
Overall response rate (ORR)
Measured: 18 months
Duration of response (DOR)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590719
- Sponsor's protocol ID
- YO28252
- Other IDs
- 2012-000858-57
- Status last verified
- Aug 2016
- First submitted
- 2 May 2012
- Last updated
- 9 Aug 2016
- Results posted
- No
Publications
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.
PubMed 27401892
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01590719
- Acronym / sponsor ID
- YO28252
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Onartuzumab (MetMAb) with mFOLFOX6 | Experimental | Drug: Onartuzumab (MetMAb), Drug: Oxaliplatin, Drug: Folinic acid, Drug: Levofolinic acid, Drug: 5-FluorouracilOnartuzumab (MetMAb) in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid [leucovorin], and oxaliplatin) |
| Placebo with mFOLFOX6 | Placebo comparator | Drug: Placebo, Drug: Oxaliplatin, Drug: Folinic acid, Drug: Levofolinic acid, Drug: 5-FluorouracilPlacebo in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid [leucovorin], and oxaliplatin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboRepeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment | Drug | Placebo with mFOLFOX6 |
| Onartuzumab (MetMAb)Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment | Drug | Onartuzumab (MetMAb) with mFOLFOX6 |
| OxaliplatinOxaliplatin 85 mg/m2 IV every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment | Drug | Onartuzumab (MetMAb) with mFOLFOX6, Placebo with mFOLFOX6 |
| Folinic acidFolinic acid 400 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment | Drug | Onartuzumab (MetMAb) with mFOLFOX6, Placebo with mFOLFOX6 |
| Levofolinic acidIf 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 | Drug | Onartuzumab (MetMAb) with mFOLFOX6, Placebo with mFOLFOX6 |
| 5-Fluorouracil5-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 | Drug | Onartuzumab (MetMAb) with mFOLFOX6, Placebo with mFOLFOX6 |
Primary outcome
Progression-free survival (PFS) in all patients
Time frame: Up to 18 months
Progression-free survival (PFS) in patients with Met-positive tumors
Time frame: Up to 18 months
4 secondary outcomes
Safety: incidence of adverse events
Time frame: 18 months
Overall survival (OS)
Time frame: 18 months
Overall response rate (ORR)
Time frame: 18 months
Duration of response (DOR)
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Derived from this study: PubMed 27401892Shah 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
36 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Onartuzumab (MetMAb), Oxaliplatin and Folinic acid in people with Gastric Cancer, run by Hoffmann-La Roche at 36 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Australia, Taiwan, South Korea, Thailand and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) in all patients (time frame: Up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01590719, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2016.