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

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ClinicalTrials.gov Identifier: NCT00907504
Recruitment Status : Withdrawn
First Posted : May 22, 2009
Last Update Posted : June 17, 2014
Sponsor:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: CP-751,871 Drug: Cisplatin Drug: Gemcitabine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2010
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Dec 2012 ]

Secondary Outcome Measures :
  1. Progression Free survival [ Time Frame: Dec 2011 ]
  2. Objective Response [ Time Frame: Dec 2011 ]
  3. Overall Safety Profile [ Time Frame: Dec 2012 ]
  4. Patient Reported Outcome [ Time Frame: Dec 2012 ]
  5. Pharmacokinetics [ Time Frame: Dec 2012 ]
  6. Anti-drug Antibody [ Time Frame: Dec 2012 ]
  7. Biomarker Analysis [ Time Frame: Dec 2012 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907504


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

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00907504     History of Changes
Other Study ID Numbers: A4021017
First Posted: May 22, 2009    Key Record Dates
Last Update Posted: June 17, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Antibodies, Monoclonal
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs