NCT00794417

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to determine whether the combination of aflibercept, pemetrexed and cisplatin is safe and effective in treating non-small cell lung cancer (NSCLC).

Detailed description

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.

Conditions

• Advanced Carcinoma
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Aflibercept	Administered in combination with the other two interventions via intravenous infusion.
DRUG	Pemetrexed	Administered in combination with the other two interventions via intravenous infusion.
DRUG	Cisplatin	Administered in combination with the other two interventions via intravenous infusion.

Timeline

• Start date: 2008-11-30
• Primary completion: 2011-06-30
• Completion: 2011-06-30
• First posted: 2008-11-20
• Last updated: 2020-12-10
• Results posted: 2020-12-10

Locations

15 sites across 2 countries: United States, Canada