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Also known as Onartuzumab (MetMAb), RO5490258, MetMAb
Onartuzumab · 10 trials · 6 indications
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Progression-free survival was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).
Progression-free survival (PFS) in participants with Met Diagnostic-Positive tumors as determined by immunohistochemistry. PFS was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).
| Arm | Type | Description |
|---|---|---|
| Control and/or Onartuzumab treatment | EXPERIMENTAL | Participants will receive treatment with either the control treatment (erlotinib, bevacizumab) and/or onartuzumab-based study treatment (as during their P-trial) until progression of disease, unacceptable treatment related toxicity, withdrawal of consent, or death (whichever occurs first). All participants will continue on the same dose and schedule of control treatment as specified in their respective P-trial. The dose of onartuzumab will be calculated based on the participant's weight at the screening visit for the E-trial. |
| erlotinib [Tarceva] + placebo | PLACEBO_COMPARATOR | - |
| erlotinib [Tarceva] + onartuzumab [MetMAb] | EXPERIMENTAL | - |
| Onartuzumab + Erlotinib | EXPERIMENTAL | - |
| Placebo + Erlotinib | ACTIVE_COMPARATOR | - |
| Onartuzumab+Erlotinib | EXPERIMENTAL | Participants will receive onartuzumab 15 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every cycle of 3 weeks along with erlotinib 150 mg tablet orally once daily (QD) from Day 1, Cycle 1 until there is evidence of disease progression, death, or unacceptable toxicity, whichever occurred first. |
| Placebo+Erlotinib | PLACEBO_COMPARATOR | Participants will receive onartuzumab matching placebo on Day 1 of every cycle of 3 weeks along with erlotinib 150 mg tablet orally QD from Day 1, Cycle 1 until there is evidence of disease progression, death, or unacceptable toxicity, whichever occurred first. |
| Onartuzumab (MetMAb) with mFOLFOX6 | EXPERIMENTAL | Onartuzumab (MetMAb) in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid \[leucovorin\], and oxaliplatin) |
| Placebo with mFOLFOX6 | PLACEBO_COMPARATOR | Placebo in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid \[leucovorin\], and oxaliplatin) |
| MetMAb+paclitaxel+platinum | EXPERIMENTAL | - |
| Placebo+paclitaxel+platinum | ACTIVE_COMPARATOR | - |
| Bevacizumab+MetMAb | EXPERIMENTAL | - |
| Bevacizumab+Placebo | ACTIVE_COMPARATOR | - |
| Pemetrexed+MetMAb | EXPERIMENTAL | - |
| Pemetrexed+Placebo | ACTIVE_COMPARATOR | - |
| Onartuzumab + Bevacizumab + Paclitaxel | EXPERIMENTAL | Participants will receive treatment with onartuzumab, bevacizumab, and paclitaxel, which may continue until disease progression, unacceptable drug-related toxicity, investigator decision, death, or completion of study, whichever occurs first (up to approximately 5 years). |
| Onartuzumab + Placebo + Paclitaxel | EXPERIMENTAL | Participants will receive treatment with onartuzumab, placebo matching to bevacizumab, and paclitaxel, which may continue until disease progression, unacceptable toxicity, investigator decision, death, or completion of study, whichever occurs first (up to approximately 5 years). |
| Placebo + Bevacizumab + Paclitaxel | ACTIVE_COMPARATOR | Participants will receive treatment with placebo matching to onartuzumab, bevacizumab, and paclitaxel, which may continue until disease progression, unacceptable toxicity, investigator decision, death, or completion of study, whichever occurs first (up to approximately 5 years). |
| MetMAb + Erlotinib | EXPERIMENTAL | MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity. |
| Cohort 1 (Onartuzumab) | EXPERIMENTAL | - |
| Cohorts 2/3 (Onartuzumab + Sorafenib) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Onartuzumab | DRUG | Onartuzumab 10 mg/kg or 15 mg/kg will be administered intravenously on Day 1 of each 14- or 21-day cycle as specified in the P-trial and as per clinical judgment and discretion of the investigator. The actual dose of onartuzumab will be determined on the bases of participants weight at the time of enrollment in extension trial (E-trial). |
| Bevacizumab | DRUG | All participants will continue on the same dose and schedule of control treatment (bevacizumab) as specified in their respective P-trial. |
| Erlotinib | DRUG | All participants will continue on the same dose and schedule of control treatment (erlotinib) as specified in their respective P-trial. |
| erlotinib [Tarceva] | DRUG | 150 mg oral administration once daily |
| Placebo | DRUG | 15 mg/kg intravenous administration every 3 weeks |
| Onartuzumab [MetMAb] | DRUG | 15 mg/kg intravenous administration every 3 weeks |
| Onartuzumab (MetMab) | DRUG | Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle. |
| Oxaliplatin | DRUG | Oxaliplatin 85 mg/m2 IV every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment |
| Folinic acid | DRUG | Folinic acid 400 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment |
| Levofolinic acid | DRUG | 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-Fluorouracil | DRUG | 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 |
| cisplatin/carboplatin | DRUG | standard dose iv, Day 1 of each 21-day cycle, 4 cycles |
| paclitaxel | DRUG | 200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles |
| RO5490258 | DRUG | 15 mg/kg iv, Day 1 of each 21-day cycle |
| bevacizumab [Avastin] | DRUG | 15 mg/kg iv, Day 1 of each 21-day cycle |
| pemetrexed | DRUG | 500 mg/m2, Day 1 of each 21-day cycle |
| Bevacizumab Placebo | DRUG | Placebo matching to bevacizumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle. |
| Onartuzumab Placebo | DRUG | Placebo matching to onartuzumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle. |
| Erlotinib HCl | DRUG | Erlotinib 150 mg oral dose once daily. |
| MetMAb | DRUG | MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg in 250 CC 0.9% saline intravenous infusion every 3 weeks. |
| placebo (0.9 % saline) | DRUG | Placebo Intravenous infusion every 3 weeks. |
| Sorafenib | DRUG | Sorafenib 400 milligram (mg) tablets (2 tablets of 200 mg each) orally once daily or twice daily depending on the cohort assigned until disease progression or unacceptable toxicity occurs (maximum up to 31 months). |
Inclusion Criteria: * Enrolled and receiving either control treatment or onartuzumab-based study treatment in an eligible P-trial * Has not met the treatment discontinuation criteria specified in their P-trial protocol at the time of enrollment into the extension trial (E-trial) * Ability to begin ...
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Onartuzumab is an investigational monoclonal antibody that has been studied in several cancer types, including non-small cell lung cancer, non-squamous non-small cell lung cancer, gastric cancer, breast cancer, hepatocellular carcinoma, and solid tumors. It was developed as a treatment for patients with MET-positive tumors, meaning its use in trials was restricted to biomarker-selected patients.
Onartuzumab targets MET, also known as the hepatocyte growth factor receptor. It acts as a MET antagonist, meaning it is designed to block MET signaling rather than activate it. This mechanism was intended to interfere with a pathway that can drive tumor growth and progression in cancers where MET is overactive.
Onartuzumab is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical studies of the drug, including the extension study and the combination trials conducted across multiple countries in North America, Europe, and Asia.
Onartuzumab is in Phase 2 development overall and is not approved. Individual studies of the drug have been conducted at different stages, including Phase 1 and Phase 3 trials, but all of them are now completed. No active trials of Onartuzumab are currently listed.
Onartuzumab has been evaluated in completed trials including NCT02488330, an extension study in solid tumors; NCT02031744, a Phase 3 study with Tarceva in MET-positive non-small cell lung cancer; NCT01897038, a Phase 1 study alone or with sorafenib in hepatocellular carcinoma; and NCT01887886, a Phase 3 study with erlotinib in EGFR-mutant non-small cell lung cancer.
Yes, Onartuzumab is also known as MetMAb. The names Onartuzumab (MetMAb), onartuzumab [MetMAb], and Onartuzumab (MetMab) all refer to the same monoclonal antibody developed by Roche, so searches using either name point to the same investigational cancer drug.