Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer (ADVIGO1017)

June 16, 2014 updated by: Pfizer

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CP-751,871 + Gemcitabine + Cisplatin
investigational arm
Drug: CP-751,871
CP-751,871 20mg/kg every 3 weeks
Drug: Cisplatin
Cisplatin 80 mg/m2 every 3 weeks
Drug: Gemcitabine
Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle
Active Comparator: Gemcitabine + Cisplatin
standard of care
Drug: Cisplatin
Cisplatin 80 mg/m2 every 3 weeks
Drug: Gemcitabine
Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: Dec 2012
Dec 2012

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free survival
Time Frame: Dec 2011
Dec 2011
Objective Response
Time Frame: Dec 2011
Dec 2011
Overall Safety Profile
Time Frame: Dec 2012
Dec 2012
Patient Reported Outcome
Time Frame: Dec 2012
Dec 2012
Pharmacokinetics
Time Frame: Dec 2012
Dec 2012
Anti-drug Antibody
Time Frame: Dec 2012
Dec 2012
Biomarker Analysis
Time Frame: Dec 2012
Dec 2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

May 20, 2009

First Submitted That Met QC Criteria

May 20, 2009

First Posted (Estimate)

May 22, 2009

Study Record Updates

Last Update Posted (Estimate)

June 17, 2014

Last Update Submitted That Met QC Criteria

June 16, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4021017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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