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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

Last updated on May 11, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small-Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Uncontrolled hypertension or diabetes;

- Pregnant female;

- Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic
corticosteroids.

NCT00907504
Pfizer
Withdrawn
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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Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • 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
  • Experimental: CP-751,871 + Gemcitabine + Cisplatin
    investigational arm
    Interventions:
    • Drug: CP-751,871
    • Drug: Cisplatin
    • Drug: Gemcitabine
  • Active Comparator: Gemcitabine + Cisplatin
    standard of care
    Interventions:
    • Drug: Cisplatin
    • Drug: Gemcitabine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2014
May 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Canada
 
NCT00907504
A4021017
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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