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Study Of CP-751,871 In Combination With Cisplatin And Gemcitabine In Chemotherapy-Naïve Patients With Advanced Non-Small Cell Lung Cancer

Last updated on December 1, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Charleroi, , 6000 Belgium
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

- Histologically or cytologically proven diagnosis of Stage IIIB (N3 and/or T4) or
Stage IV Non-Small Cell Lung Cancer in patients 18-year-old or older, with Eastern
Cooperative Oncology Group (ECOG) performance status of 0 or 1 not amenable to
curative surgery or radiation therapy and an adequate organ function (bone marrow,
hepatic, renal, and cardiac) within 14 days prior to enrollment.

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

- Any prior treatment for Non-Small Cell Lung Cancer including chemotherapy, biologic
response modifiers or therapy with any investigational agents.

- Patients with known brain metastases, spinal cord compression, uncontrolled superior
vein cava syndrome or carcinomatous meningitis.

- Patients with gastrointestinal abnormalities including active gastrointestinal
bleeding, pre-diabetes (pre-fasting glycemia > 120 g/dL and/or glycosylate
haemoglobin level > 7.5%), known HIV or AIDS-related illness, significant active
cardiac disease or receiving chronic steroid therapy or concurrent use of growth
hormones or growth hormone inhibitors or aminoglycoside antibiotics should be
excluded from the study.

NCT00560573
Pfizer
Completed
Study Of CP-751,871 In Combination With Cisplatin And Gemcitabine In Chemotherapy-Naïve Patients With Advanced Non-Small Cell Lung Cancer

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Descriptive Information
Brief Title  ICMJE Study Of CP-751,871 In Combination With Cisplatin And Gemcitabine In Chemotherapy-Naïve Patients With Advanced Non-Small Cell Lung Cancer
Official Title  ICMJE Phase 1, Dose Escalation Study Of CP-751,871 In Combination With Cisplatin And Gemcitabine In Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer
Brief SummaryCP 751,871 is a fully human monoclonal antibody against the Insulin-Like Growth Factor 1 Receptor (IGF-1R). Preclinical and clinical data indicate that CP 751,871 augments the anti-tumor activity of chemotherapy. This study will identify the Maximal Tolerated Dose of CP 751,871 (or the Maximal Feasible Dose) in combination with standard gemcitabine-cisplatin chemotherapy for the treatment of advanced Non-Small Cell Lung cancer.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: CP-751,871
    CP-751,871 at doses ranging from 6 to 20 mg/Kg on Day 1 of each 21-day cycle. CP-751,871 may be administered even after active comparators discontinuation, for a total number of 17 cycles (1 year).
  • Drug: Cisplatin

    Cisplatin 75* mg/m2 or 80* mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycles.

    * 75 mg/m2 when in combination with pemetrexed, 80 mg/m2 when in combination with gemcitabine

  • Drug: Gemcitabine
    Gemcitabine 1250 mg/m2, IV on Days 1 and 8 of each 21-day cycle up to 6 cycles
  • Drug: Pemetrexed
    Pemetrexed 500 mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycle
Study Arms  ICMJE Experimental: 1
Interventions:
  • Drug: CP-751,871
  • Drug: Cisplatin
  • Drug: Gemcitabine
  • Drug: Pemetrexed
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2013)
46
Original Estimated Enrollment  ICMJE
 (submitted: November 15, 2007)
42
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion DateJune 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically proven diagnosis of Stage IIIB (N3 and/or T4) or Stage IV Non-Small Cell Lung Cancer in patients 18-year-old or older, with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 not amenable to curative surgery or radiation therapy and an adequate organ function (bone marrow, hepatic, renal, and cardiac) within 14 days prior to enrollment.

Exclusion Criteria:

  • Any prior treatment for Non-Small Cell Lung Cancer including chemotherapy, biologic response modifiers or therapy with any investigational agents.
  • Patients with known brain metastases, spinal cord compression, uncontrolled superior vein cava syndrome or carcinomatous meningitis.
  • Patients with gastrointestinal abnormalities including active gastrointestinal bleeding, pre-diabetes (pre-fasting glycemia > 120 g/dL and/or glycosylate haemoglobin level > 7.5%), known HIV or AIDS-related illness, significant active cardiac disease or receiving chronic steroid therapy or concurrent use of growth hormones or growth hormone inhibitors or aminoglycoside antibiotics should be excluded from the study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Ireland,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00560573
Other Study ID Numbers  ICMJE A4021015
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 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 the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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