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Combination Study Of CP-751,871 With Paclitaxel And Carboplatin In Advanced Lung Cancer

Last updated on May 12, 2018

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Study Location
Pfizer Investigational Site
Tucson, Arizona, 85719 United States
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

- Diagnosis of advanced/metastatic lung cancer

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

- Previous treatment with chemotherapy

- Uncontrolled diabetes

- History/active cardiovascular disease

NCT00147537
Pfizer
Completed
Combination Study Of CP-751,871 With Paclitaxel And Carboplatin In Advanced Lung Cancer

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Combination Study Of CP-751,871 With Paclitaxel And Carboplatin In Advanced Lung Cancer
A Phase 1b Dose Escalation/Phase 2 Randomized, Non-Comparative, Multiple Center, Open Label Study Of CP 751,871 In Combination With Paclitaxel And Carboplatin And Of Paclitaxel And Carboplatin Alone As First Line Treatment For Advanced Non-Small Cell Lung Cancer

Phase 1b Dose Excalation/Expansion: Identify and characterize safety and tolerability of recommended phase 2 dose of CP-751,871 when administered with paclitaxel and carboplatin Phase 1b Erlotinib Extension: To characterize the safety and tolerability of CP751,871 when administered with paclitaxel, carboplatin and erlotinib.

Phase 2: To test the efficacy of CP-751,871 combined with paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • Drug: CP-751,871

    Phase 2 Arm A:

    CP?751,871 20 mg/kg IV over 2.5 hours up to 17 cycles

  • Drug: paclitaxel

    Phase 2 Arm A:

    Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles

    Phase 2 Arm B:

    Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles

  • Drug: carboplatin

    Phase 2 Arm A:

    Carboplatin AUC 6, IV over 15?60 minutes up to 6 cycles

    Phase 2 Arm B:

    Carboplatin AUC 6, IV over 15?60 minutes up to 6 cycles

  • Drug: CP-751,871
    Phase 1b Dose Escalation/Expansion: CP?751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles) Phase 1b Erlotinib Extension: CP?751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles)
  • Drug: paclitaxel
    Phase 1b Dose Escalation/Expansion: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles) Phase 1b Erlotinib Extension: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles)
  • Drug: carboplatin
    Phase 1b Dose Escalation/Expansion: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles) Phase 1b Erlotinib Extension: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles)
  • Drug: erlotinib
    Phase 1b Erlotinib Extension: erlotinib 150 mg/day orally every day (up to 17 cycles)
  • Experimental: Phase 2 (Arms A & B)
    CP-751,871 + paclitaxel + carboplatin
    Interventions:
    • Drug: CP-751,871
    • Drug: paclitaxel
    • Drug: carboplatin
  • Experimental: Phase 1b
    1. Phase 1b Dose Escalation /Expansion: CP-751,871 + paclitaxel + carboplatin
    2. Phase 1b Erlotinib Extension: CP-751,871 + paclitaxel + carboplatin + erlotinib
    Interventions:
    • Drug: CP-751,871
    • Drug: paclitaxel
    • Drug: carboplatin
    • Drug: erlotinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
282
August 2011
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of advanced/metastatic lung cancer

Exclusion Criteria:

  • Previous treatment with chemotherapy
  • Uncontrolled diabetes
  • History/active cardiovascular disease
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Italy,   Spain,   United States
 
 
NCT00147537
A4021002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2013

ICMJE     Data element required by the

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

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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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