Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer
ADVIGO1017
Randomized, Open Label, Phase 3 Clinical Study To Evaluate The Effect Of The Addition Of CP-751,871 To Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs, 1,210 participants will be required in order to have an adequate sample size (1,100 evaluable patients) and power to detect a 30% prolongation of survival on the experimental arm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2010
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2009
CompletedFirst Posted
Study publicly available on registry
May 22, 2009
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJune 17, 2014
June 1, 2014
3.8 years
May 20, 2009
June 16, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
Dec 2012
Secondary Outcomes (7)
Progression Free survival
Dec 2011
Objective Response
Dec 2011
Overall Safety Profile
Dec 2012
Patient Reported Outcome
Dec 2012
Pharmacokinetics
Dec 2012
- +2 more secondary outcomes
Study Arms (2)
CP-751,871 + Gemcitabine + Cisplatin
EXPERIMENTALinvestigational arm
Gemcitabine + Cisplatin
ACTIVE COMPARATORstandard of care
Interventions
Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle
Eligibility Criteria
You may qualify if:
- Non-Small Cell Lung Cancer (NSCLC), advanced, chemotherapy-naive
- Male or female \> 18 years
- Eastern Oncology Cooperative Group (ECOG) Performance Status (PS) 0 or 1
- Adequate organ function
You may not qualify if:
- Uncontrolled hypertension or diabetes;
- Pregnant female;
- Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic corticosteroids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 20, 2009
First Posted
May 22, 2009
Study Start
July 1, 2010
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
June 17, 2014
Record last verified: 2014-06