Approval Probability
TA Base Rate
Adjusted LOA
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Also known as bevacizumab, Bevacizumab
Avastin · 2 trials · 2 indications
Time from study entry to disease progression or death
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
| Arm | Type | Description |
|---|---|---|
| Treatment Period | EXPERIMENTAL | Treatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle. |
| A+FFG | EXPERIMENTAL | Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid |
| A+FOLFOX 4 | ACTIVE_COMPARATOR | Avastin + Oxaliplatin + 5-Fluorouracil (5FU)/Folinic Acid |
| Name | Type | Description |
|---|---|---|
| Paclitaxel | DRUG | Patients will be premedicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins. |
| Gemcitabine | DRUG | Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel. |
| Avastin | DRUG | 10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions. |
| 5FU/folinic acid | DRUG | Folinic Acid: 100 milligrams per square meter (mg/m2) intravenous (IV) over 60 minutes (A+FFG). Folinic Acid: 200 mg/m2 as a 2-hr infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4). 5-Fluorouracil: 450 mg/m2 as an IV bolus in middle of Folinic Acid (A+FFG). 5-Fluorouracil: 400 mg/m2 bolus plus a 600 mg/m2 22-hour infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4). |
| oxaliplatin | DRUG | 85 mg/m2 as a 2-hour infusion on Day 1 of a 14 day cycle. |
Inclusion Criteria: * Patient must be 18 years of age or older with histologically confirmed breast cancer and clinical evidence of metastatic disease. * Patients must have measurable or non-measurable disease. X-rays, scans or physical examinations used to assess measurable disease must be perform...
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Avastin is used for colorectal cancer and metastatic breast cancer. It has been studied in clinical trials for these oncology indications, including a Phase 2 trial in colorectal cancer and a Phase 2 trial in metastatic breast cancer.
Avastin is a monoclonal antibody, classified as a -mab antibody. It is being developed by Eli Lilly and Company for use in oncology, specifically for colorectal cancer and metastatic breast cancer.
Avastin is developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker LLY.
Avastin is in Phase 2 clinical development. It has completed two Phase 2 trials, one in colorectal cancer and one in metastatic breast cancer, with a combined enrollment of 98 patients.
Avastin has been studied in two completed Phase 2 trials. NCT00192075 evaluated Avastin with gemcitabine and 5FU/folinic acid versus Avastin with oxaliplatin and 5FU/folinic acid in metastatic colorectal cancer. NCT00618826 studied biweekly gemcitabine, paclitaxel, and Avastin in metastatic breast cancer.
Yes, Avastin is also known as bevacizumab. Both names refer to the same drug, which is being developed by Eli Lilly and Company for colorectal cancer and metastatic breast cancer.