For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new medicines that work in early clinical development and will matter to patients.
VEGF Receptor-2 Antagonist
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, Refractory to or Progressive After First-line Therapy With Platinum and Fluoropyrimidine*
Key Inclusion Criteria
- Locally advanced, unresectable disease or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Documented objective radiographic or symptomatic disease progression during first-line therapy or within 4 months after the last dose of first-line therapy with any platinum/fluoropyrimidine doublet for unresectable or metastatic disease
- Adequate organ function
- Urinary protein is ≤1+ on dipstick or routine urinalysis
Key Exclusion Criteria
- Received any first-line chemotherapy other than platinum and fluoropyrimidine with or without an anthracycline for advanced gastric or GEJ adenocarcinoma
- Received any previous systemic therapy (including investigational agents) targeting VEGF or the VEGF receptor signaling pathways
- Major surgery within 28 days prior to randomization
- Serious or nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to randomization
- Significant bleeding disorders, vasculitis, or a significant bleeding episode within 3 months prior to study entry
- History of gastrointestinal perforation and/or fistulae within 6 months prior to randomization
- Experienced arterial thromboembolic event within 6 months prior to randomization
- History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to randomization
- Uncontrolled arterial hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) despite standard medical management
Contact the Lilly Oncology Clinical Trial Navigation Service
Visit www.clinicaltrials.gov for more information on this trial.
The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.