Back to resultsStudy Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer (ADVIGO1017)
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
CP-751,871
Cisplatin
Gemcitabine
Cisplatin
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Uncontrolled hypertension or diabetes;
- Pregnant female;
- Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic corticosteroids.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CP-751,871 + Gemcitabine + Cisplatin
Gemcitabine + Cisplatin
Arm Description
investigational arm
standard of care
Outcomes
Primary Outcome Measures
Overall Survival
Secondary Outcome Measures
Progression Free survival
Objective Response
Overall Safety Profile
Patient Reported Outcome
Pharmacokinetics
Anti-drug Antibody
Biomarker Analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00907504
Brief Title
Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer
Acronym
ADVIGO1017
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Withdrawn
Study Start Date
July 2010 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CP-751,871 + Gemcitabine + Cisplatin
Arm Type
Experimental
Arm Description
investigational arm
Arm Title
Gemcitabine + Cisplatin
Arm Type
Active Comparator
Arm Description
standard of care
Intervention Type
Drug
Intervention Name(s)
CP-751,871
Intervention Description
CP-751,871 20mg/kg every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 80 mg/m2 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 80 mg/m2 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
Dec 2012
Secondary Outcome Measure Information:
Title
Progression Free survival
Time Frame
Dec 2011
Title
Objective Response
Time Frame
Dec 2011
Title
Overall Safety Profile
Time Frame
Dec 2012
Title
Patient Reported Outcome
Time Frame
Dec 2012
Title
Pharmacokinetics
Time Frame
Dec 2012
Title
Anti-drug Antibody
Time Frame
Dec 2012
Title
Biomarker Analysis
Time Frame
Dec 2012
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Uncontrolled hypertension or diabetes;
Pregnant female;
Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic corticosteroids.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4021017&StudyName=Study%20Of%20The%20Effect%20Of%20CP-751%2C871%20In%20Combination%20With%20Gemcitabine%20And%20Cisplatin%20In%20Patients%20With%20Advanced%20Non-Small%20Cell%20Lung%20Cancer
Description
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Learn more about this trial
Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer
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