Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ramucirumab DP · 4 trials · 7 indications
OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.
OS was defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up were censored on the last date the participant was known to be alive.
PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow-up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.
| Arm | Type | Description |
|---|---|---|
| Ramucirumab (IMC-1211B) Drug Product (DP) and Paclitaxel | EXPERIMENTAL | Ramucirumab (IMC-1211B) DP and Paclitaxel |
| Placebo and Paclitaxel | PLACEBO_COMPARATOR | Placebo and Paclitaxel |
| Ramucirumab DP and BSC | EXPERIMENTAL | - |
| Placebo and BSC | PLACEBO_COMPARATOR | - |
| Docetaxel | ACTIVE_COMPARATOR | Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. |
| Docetaxel + Ramucirumab DP | EXPERIMENTAL | Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. |
| Docetaxel + Icrucumab | EXPERIMENTAL | Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. |
| Ramucirumab DP + Capecitabine | EXPERIMENTAL | Cycles repeat until disease progression, the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant. |
| Icrucumab + Capecitabine | EXPERIMENTAL | Cycles repeat until disease progression, the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant. |
| Capecitabine* | ACTIVE_COMPARATOR | Crossover Study: \* At the discretion of the investigator, participants will be eligible to receive either ramucirumab DP or Icrucumab (IMC-18F1) in combination with capecitabine, after radiographic disease progression while on capecitabine. The investigator will decide which investigational product will be given. Cycles repeat every 21 days until disease progression, the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant. |
| Name | Type | Description |
|---|---|---|
| Ramucirumab (IMC-1211B) DP | BIOLOGICAL | 8 milligrams/kilogram (mg/kg) intravenous (IV) infusion on Days 1 and 15 of every 4-week cycle |
| Placebo | DRUG | Ramucirumab placebo IV infusion on Days 1 and 15 of every 4-week cycle |
| Paclitaxel | DRUG | Paclitaxel 80 milligrams per square meter (mg/m²) IV infusion on Days 1, 8, and 15 of every 4-week cycle |
| Ramucirumab DP (IMC-1121B) | BIOLOGICAL | 8 milligrams/kilogram (mg/kg) intravenous (IV) every 2 weeks |
| BSC | OTHER | Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator. |
| Docetaxel | DRUG | Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle |
| Ramucirumab DP | BIOLOGICAL | Ramucirumab (DP): 10 milligram/kilogram (mg/kg) intravenous (IV) on day 1 of each 21-day cycle |
| Icrucumab | BIOLOGICAL | 12 mg/kg I.V. on day 1 and Day 8 of each 21-day cycle |
| IMC-18F1 | BIOLOGICAL | 12 mg/kg I.V. Days 1 and 8 of every-21-day cycle |
| Capecitabine | DRUG | 1000 mg/m\^2 orally Twice a day for 14 days |
Inclusion Criteria: * Signed informed consent * histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma * Metastatic disease or locally advanced, unresectable disease * Disease progression during or within 4 months after the last dose of the first-line therapy ...
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Ramucirumab DP is an investigational monoclonal antibody being studied in oncology for several cancers, including breast cancer, carcinoma of the urinary tract, hepatocellular carcinoma, and gastric cancer. It is developed by Eli Lilly and Company (LLY) and is currently in Phase 2 clinical development.
Ramucirumab DP is a monoclonal antibody that targets the vascular endothelial growth factor receptor, which plays a role in tumor angiogenesis. By binding to this receptor, it is designed to inhibit the growth of blood vessels that supply tumors, potentially slowing cancer progression.
Ramucirumab DP is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is currently in Phase 2 clinical trials for multiple oncology indications.
Ramucirumab DP is currently in Phase 2 clinical development. It has completed one Phase 2 trial and is also associated with completed Phase 3 trials for hepatocellular carcinoma and gastric cancer, though the drug itself remains investigational and not yet approved.
Ramucirumab DP has been studied in several completed trials, including NCT01140347 for hepatocellular carcinoma, NCT01170663 for gastric cancer, NCT01234402 for breast cancer, and NCT01282463 for carcinoma of the urinary tract. These trials have collectively enrolled over 1,500 participants.
Ramucirumab DP is also known as IMC-1121B, as referenced in clinical trial titles. It is distinct from IMC-1211B, which appears in a gastric cancer trial, and from IMC-18F1 (icrucumab), which was studied in combination with ramucirumab in breast cancer trials.