Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vitamin B12 · 2 trials · 4 indications
Number of events of brain or central nervous system (CNS) bleeding
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size \[\<10 millimeter (mm) short axis\]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.
| Arm | Type | Description |
|---|---|---|
| bevacizumab+ pemetrexed | EXPERIMENTAL | pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV). In addition to Vitamin B12 + Folate + Dexamethasone |
| Pemetrexed + Cisplatin | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bevacizumab | DRUG | 15 mg/kg, IV over 10 minutes every 3 weeks |
| Pemetrexed | DRUG | 500 mg/m²; IV over 10 minutes every 3 weeks |
| Vitamin B12 | DRUG | 1000 micrograms, IM injection 1-2 weeks prior to treatment and repeated every 9 weeks until last dose of pemetrexed |
| Folate | DRUG | 350 to 1000 micrograms 1 week prior to treatment and 3 weeks after last pemetrexed dose |
| Dexamethasone | DRUG | 4 mg; oral, twice a day at the following times: the day before, of and after each dose of pemetrexed |
| Cisplatin | DRUG | 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles |
| Folic Acid | DRUG | Administered orally. |
Inclusion Criteria: * Advanced stage NSCLC excluding squamous cell histology with measurable or evaluable disease. * Stable brain metastases required, no longer requiring active therapy such as steroid medications, which have been previously treated with radiation or surgery or both and have been d...
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Vitamin B12 is being studied as a supplement in combination with chemotherapy regimens for Non-Small Cell Lung Cancer (NSCLC). It is used in clinical trials alongside pemetrexed-based treatments to support patients undergoing therapy. The drug is in Phase 2 clinical development for this oncology indication.
Vitamin B12 is being developed by Eli Lilly and Company, which trades under the ticker LLY on the stock exchange. The company is conducting clinical research on this drug in the context of Non-Small Cell Lung Cancer treatment.
Vitamin B12 is in Phase 2 clinical development for Non-Small Cell Lung Cancer (NSCLC). It is an investigational drug in this context, meaning it has not yet been approved by regulatory authorities. The Phase 2 trials have been completed.
Vitamin B12 has been studied in two completed Phase 2 clinical trials. NCT00227019 evaluated bevacizumab in combination with pemetrexed in 16 patients with NSCLC. NCT01165021 studied pemetrexed/cisplatin as pre-operative treatment in 19 patients with early stage nonsquamous NSCLC.
Vitamin B12 is a general term for a group of compounds, and cyanocobalamin is one synthetic form. In the context of these clinical trials, the drug is referred to as Vitamin B12, and no alternative names have been specified in the trial data.