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Onartuzumab · 10 trials · 8 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.
| 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) |
| Onartuzumab + Bevacizumab | EXPERIMENTAL | All participants will receive onartuzumab intravenous (IV) infusion followed by bevacizumab IV infusion every 3 weeks. |
| Placebo + Bevacizumab | ACTIVE_COMPARATOR | All participants will receive placebo matched with onartuzumab followed by bevacizumab IV infusion every 3 weeks. |
| MetMAb+paclitaxel+platinum | EXPERIMENTAL | - |
| Placebo+paclitaxel+platinum | ACTIVE_COMPARATOR | - |
| A | EXPERIMENTAL | - |
| B | 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). |
| 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 |
| 5-FU | DRUG | Intravenous repeating dose |
| FOLFOX regimen | DRUG | Intravenous repeating dose |
| bevacizumab [Avastin] | DRUG | Intravenous repeating dose |
| leucovorin | DRUG | Intravenous repeating dose |
| 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. |
| 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 oncology drug being studied for use in Non-Small Cell Lung Cancer, Glioblastoma, Hepatocellular Carcinoma, Gastric Cancer, Colorectal Cancer, and Solid Tumors. It is developed by Roche Holding AG and is currently in Phase 2 clinical development.
Onartuzumab targets the MET receptor, a protein involved in tumor growth and metastasis. By binding to MET, it aims to disrupt signaling pathways that promote cancer cell proliferation. This mechanism is being evaluated in several solid tumor types, including Non-Small Cell Lung Cancer.
Onartuzumab is being developed by Roche Holding AG, a multinational healthcare company. Roche is conducting clinical trials to evaluate the drug's safety and efficacy in various oncology indications, including Non-Small Cell Lung Cancer and other solid tumors.
Onartuzumab is currently in Phase 2 clinical development. It has completed three trials, including Phase 2 and Phase 3 studies, with a total enrollment of 612 participants. The drug is investigational and has not been approved by regulatory authorities.
Onartuzumab has been studied in several clinical trials, including NCT01456325, a Phase 3 study in Non-Squamous Non-Small Cell Lung Cancer, and NCT01519804, a Phase 2 study in the same condition. NCT01887886 evaluated it in MET-Positive Non-Small Cell Lung Cancer with EGFR mutations, and NCT02488330 was an extension study in solid tumors.
Yes, Onartuzumab is also known as MetMAb. In clinical trials, it is sometimes referred to by this alternative name, which reflects its targeting of the MET receptor. Researchers and clinicians may use either name when discussing the drug.