Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00907504
• Other study ID #: A4021017
• Status: Withdrawn
• Phase: Phase 3
• First received: May 20, 2009
• Last updated: June 16, 2014
• Start date: July 2010
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• CP-751,871
CP-751,871 20mg/kg every 3 weeks
• Cisplatin
Cisplatin 80 mg/m2 every 3 weeks
• Gemcitabine
Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle
• Cisplatin
Cisplatin 80 mg/m2 every 3 weeks
• Gemcitabine
Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		Dec 2012	No
Secondary	Progression Free survival		Dec 2011	No
Secondary	Objective Response		Dec 2011	No
Secondary	Overall Safety Profile		Dec 2012	No
Secondary	Patient Reported Outcome		Dec 2012	No
Secondary	Pharmacokinetics		Dec 2012	No
Secondary	Anti-drug Antibody		Dec 2012	No
Secondary	Biomarker Analysis		Dec 2012	No

External Links

•   To obtain contact information for a study center near you, click here.