Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regeneron Pharmaceuticals
With
Sanofi
The study was conducted in two phases. In phase 1, patients with advanced cancer received different doses of aflibercept in combination with approved doses of pemetrexed and cisplatin. The objective of phase 1 was to determine the safest dose of the combined study medications. This dose was administered to patients with previously untreated NSCLC in phase 2. The phase 2 portion of the study determined if the combination is effective in treating NSCLC.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Confirmation of cancer by biopsy (tissue sample)
Phase 1: patients with advanced or metastatic disease that have failed conventional therapy
Phase 2: patients with previously untreated NSCLC, excluding squamous cell histology and cavitating lesions
Age ≥18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Adequate renal, liver and bone marrow function.
Negative pregnancy test (serum or urine) in females of childbearing potential within 7 days of the initial dose of aflibercept
Ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Institutional Review Board (IRB) approved, signed and dated informed consent form
You may not be if
Prior treatment with study medications
Untreated, symptomatic, or progressive Central Nervous System cancer and/or spinal cord compression. Patients with treated brain metastases must have been without symptoms for at least 3 months
Surgery up to 4 weeks prior to the initial administration of aflibercept and/or incomplete wound healing
Anti-VEGF therapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
Chemotherapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
Other investigational treatment up to 4 weeks prior to the initial administration of aflibercept
Any of the following up to 6 months (24 weeks) prior to the initial administration of aflibercept:
* Severe cardiovascular disease or event
* Cerebrovascular accident, transient ischemic attack, or moderate to severe peripheral neuropathy
* Erosive esophagitis or gastritis, infectious or inflammatory bowel disease, and diverticulitis
* Deep vein thrombosis, pulmonary embolism, or other clotting event
* Episode(s)of moderate to severe, continuous bleeding
Breast-feeding or pregnancy
Clareo Health | A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma
