A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00794417
• Date of registration: 19/11/2008
• Primary sponsor: Regeneron Pharmaceuticals
• Public title: A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma
• Scientific title: A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma
• Date of first enrolment: November 2008
• Target sample size: 62
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00794417
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada, United States

Contacts

• Name: Clinical Trial Management
• Affiliation: Regeneron Pharmaceuticals

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Advanced Carcinoma

Non-small Cell Lung Cancer

Intervention(s)

Biological: Aflibercept

Biological: Cisplatin

Biological: Pemetrexed

Primary Outcome(s)

Phase 1: Dose limiting toxicities; Phase 2: Objective Response Rate (ORR) and Progression Free Survival (PFS) [Time Frame: 6 months]

Secondary Outcome(s)

Safety, pharmacokinetic and immunogenic profile of aflibercept when given in combination with pemetrexed and cisplatin [Time Frame: 12 months]

Secondary ID(s)

TCD10767

VGFT-ST-0708

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi-Aventis