A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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