Clinical trial · Interventional
FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment in Patients With Metastatic Colorectal Cancer
Randomized, Double-Blind, Phase II Study of FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment for Patients With Metastatic Colorectal Cancer
NCT01418222CI-TRIAL-00027820completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of FOLFOX/bevacizumab with onartuzumab (MetMAb) versus placebo as first-line treatment in patients with metastatic colorectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| bevacizumab [Avastin] | Drug | Bevacizumab | ALIAS |
| FOLFOX regimen | Drug | FOLFOX Regimen | ALIAS |
| leucovorin | Drug | Leucovorin | ALIAS |
| onartuzumab [MetMAb] | Drug | Onartuzumab | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: 5-FU
- Drug: FOLFOX regimen
- Drug: bevacizumab [Avastin]
- Drug: leucovorin
- Drug: onartuzumab [MetMAb]
- type
- ACTIVE_COMPARATOR
- label
- B
- interventionNames
- Drug: 5-FU
- Drug: FOLFOX regimen
- Drug: Placebo
- Drug: bevacizumab [Avastin]
- Drug: leucovorin
Primary outcomes (1)
- measure
- Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in patients with metastatic (Stage IV) disease * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Measurable disease by RECIST criteria * Adequate organ system function, as defined by protocol Exclusion Criteria: * Prior systemic or radiation therapy for metastatic colorectal cancer * Adjuvant chemotherapy (and/or chemoradiation) for colorectal cancer within 12 months prior to date of diagnosis of metastatic disease * Previously untreated brain metastases * History of hypersensitivity to active or inactive excipients of any component of treatment, or known dipyrimidine dehydrogenase deficiency * Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) * History of hematemesis or hemoptysis \</= 1 months prior to study enrollment * Significant cardiovascular disease or disorder * History of abdominal fistula or gastrointestinal perforation \</= 6 months prior to Day 1 * Positive for hepatitis B, hepatitis C or HIV infection * Other active cancers or history of treatment for invasive cancer within the last 5 years, except for non-melanoma skin cancer
References
Publications (1)
- DERIVEDBendell JC, Hochster H, Hart LL, Firdaus I, Mace JR, McFarlane JJ, Kozloff M, Catenacci D, Hsu JJ, Hack SP, Shames DS, Phan SC, Koeppen H, Cohn AL. A Phase II Randomized Trial (GO27827) of First-Line FOLFOX Plus Bevacizumab with or Without the MET Inhibitor Onartuzumab in Patients with Metastatic Colorectal Cancer. Oncologist. 2017 Mar;22(3):264-271. doi: 10.1634/theoncologist.2016-0223. Epub 2017 Feb 16. PMID 28209746