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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00907504
First received: May 20, 2009
Last updated: April 19, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: CP-751,971
Drug: Cisplatin
Drug: Gemcitabine
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Dec 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free survival [ Time Frame: Dec 2011 ] [ Designated as safety issue: No ]
  • Objective Response [ Time Frame: Dec 2011 ] [ Designated as safety issue: No ]
  • Overall Safety Profile [ Time Frame: Dec 2012 ] [ Designated as safety issue: No ]
  • Patient Reported Outcome [ Time Frame: Dec 2012 ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: Dec 2012 ] [ Designated as safety issue: No ]
  • Anti-drug Antibody [ Time Frame: Dec 2012 ] [ Designated as safety issue: No ]
  • Biomarker Analysis [ Time Frame: Dec 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1210
Study Start Date: July 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CP-751,871 + Gemcitabine + Cisplatin
investigational arm
Drug: CP-751,971
CP-751,971 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907504

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00907504     History of Changes
Other Study ID Numbers: A4021017
Study First Received: May 20, 2009
Last Updated: April 19, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014