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Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer

Last updated on May 11, 2018

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Study Location
Pfizer Investigational Site
Fort Smith, Arkansas, 72903 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Large Cell Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Carcinoma, Adenosquamous Cell 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 with a primary histology of squamous cell, large cell or
adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST.

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

- Primary NSCLC adenocarcinoma and its subtypes or unknown/unspecified histology.

- Prior Erlotinib therapy.

- Prior anti IGF IR based investigational therapy.

NCT00673049
Pfizer
Terminated
Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer

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Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer
Randomized, Open Label, Phase 3 Trial Of Erlotinib Alone Or In Combination With CP-751,871 In Patients With Advanced Non Small Cell Lung Cancer Of Non Adenocarcinoma Histology
The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

This study was terminated on March 8, 2010 due to an analysis by an independent Data Safety Monitoring Committee (DSMC) indicating that the addition of CP-751,871 [figitumumab] to erlotinib [Tarceva] would be unlikely to meet the primary endpoint of improving overall survival when compared to erlotinib alone.

This Oncology study continues as terminated, however for ethical reasons some patients, noted with resultant benefit, continue receiving treatment.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Carcinoma, Large Cell
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Carcinoma, Adenosquamous Cell
  • Drug: CP 751,871 (Figitumumab)
    CP 751,871 (20 mg/kg) will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.
  • Drug: Erlotinib
    Erlotinib (one tablet of 150 mg/day PO).
  • Drug: Erlotinib
    Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food.
  • Experimental: Arm A

    The CP 751,871 treatment in combination with erlotinib will be given in three week cycles.

    CP 751,871 (20 mg/kg) + erlotinib (150 mg/day) CP 751,871 will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.

    Interventions:
    • Drug: CP 751,871 (Figitumumab)
    • Drug: Erlotinib
  • Active Comparator: Arm B
    Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food)
    Intervention: Drug: Erlotinib
Scagliotti GV, Bondarenko I, Blackhall F, Barlesi F, Hsia TC, Jassem J, Milanowski J, Popat S, Sanchez-Torres JM, Novello S, Benner RJ, Green S, Molpus K, Soria JC, Shepherd FA. Randomized, phase III trial of figitumumab in combination with erlotinib versus erlotinib alone in patients with nonadenocarcinoma nonsmall-cell lung cancer. Ann Oncol. 2015 Mar;26(3):497-504. doi: 10.1093/annonc/mdu517. Epub 2014 Nov 13.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
583
April 2012
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non small cell lung cancer with a primary histology of squamous cell, large cell or adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST.

Exclusion Criteria:

  • Primary NSCLC adenocarcinoma and its subtypes or unknown/unspecified histology.
  • Prior Erlotinib therapy.
  • Prior anti IGF IR based investigational therapy.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Czech Republic,   France,   Greece,   Hungary,   Indonesia,   Ireland,   Italy,   Korea, Republic of,   Latvia,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Slovenia,   South Africa,   Spain,   Switzerland,   Taiwan,   Ukraine,   United Kingdom,   United States
Argentina
 
NCT00673049
A4021018
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2013

ICMJE     Data element required by the

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

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