Trials / Terminated
TerminatedNCT00673049
Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer
Randomized, Open Label, Phase 3 Trial Of Erlotinib Alone Or In Combination With CP-751,871 In Patients With Advanced Non Small Cell Lung Cancer Of Non Adenocarcinoma Histology
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 583 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).
Detailed description
This study was terminated on March 8, 2010 due to an analysis by an independent Data Safety Monitoring Committee (DSMC) indicating that the addition of CP-751,871 \[figitumumab\] to erlotinib \[Tarceva\] would be unlikely to meet the primary endpoint of improving overall survival when compared to erlotinib alone. This Oncology study continues as terminated, however for ethical reasons some patients, noted with resultant benefit, continue receiving treatment.
Conditions
- Carcinoma, Large Cell
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Squamous Cell
- Carcinoma, Adenosquamous Cell
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CP 751,871 (Figitumumab) | CP 751,871 (20 mg/kg) will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter. |
| DRUG | Erlotinib | Erlotinib (one tablet of 150 mg/day PO). |
| DRUG | Erlotinib | Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food. |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2011-03-01
- Completion
- 2012-04-01
- First posted
- 2008-05-07
- Last updated
- 2013-07-24
- Results posted
- 2013-07-24
Locations
175 sites across 27 countries: United States, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, France, Greece, Hungary, Indonesia, Ireland, Italy, Latvia, Poland, Puerto Rico, Romania, Russia, Serbia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00673049. Inclusion in this directory is not an endorsement.