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Also known as MetMAb, Onartuzumab (MetMab), Onartuzumab
RO5490258 · 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) |
| Bevacizumab+MetMAb | EXPERIMENTAL | - |
| Bevacizumab+Placebo | ACTIVE_COMPARATOR | - |
| Pemetrexed+MetMAb | EXPERIMENTAL | - |
| Pemetrexed+Placebo | ACTIVE_COMPARATOR | - |
| MetMAb+paclitaxel+platinum | EXPERIMENTAL | - |
| Placebo+paclitaxel+platinum | 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 |
| 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 |
| 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 |
| 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 ...
RO5490258 is an investigational small molecule being studied for the treatment of Non-Squamous Non-Small Cell Lung Cancer. It is currently in Phase 2 clinical development and is not approved for use. The drug is being evaluated in combination with other therapies to assess its safety and efficacy in this patient population.
RO5490258 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research to evaluate the drug's potential in treating Non-Squamous Non-Small Cell Lung Cancer. As an investigational agent, it is not yet available commercially.
RO5490258 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 2 study is designed to evaluate the drug's efficacy and safety in patients with Non-Squamous Non-Small Cell Lung Cancer.
RO5490258 is being studied in a completed Phase 2 clinical trial with the identifier NCT01496742. The trial enrolled 259 participants and evaluated the drug in combination with bevacizumab plus platinum and paclitaxel, or with pemetrexed plus platinum, in patients with Non-Squamous Non-Small Cell Lung Cancer.
RO5490258 is also known as onartuzumab, and the two names refer to the same investigational drug. In clinical trials, it is studied under the name onartuzumab, and it is being developed by Roche for the treatment of Non-Squamous Non-Small Cell Lung Cancer.
RO5490258 is a small molecule therapeutic agent. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being investigated for its potential role in treating Non-Squamous Non-Small Cell Lung Cancer, but its exact mechanism of action remains under study.