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Study of CP-751,871 in Combination With Carboplatin and Paclitaxel in Advanced Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00603538
First Posted: January 29, 2008
Last Update Posted: April 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
January 17, 2008
January 29, 2008
January 18, 2013
April 11, 2013
April 11, 2013
January 2008
May 2009   (Final data collection date for primary outcome measure)
Number of Participants With Dose Limiting Toxicities (DLT) [ Time Frame: Cycle 1 ]
A DLT was defined as any one of the following adverse events observed in Cycle 1 which was considered as related to CP-751,871 combination therapy; 1) >=Grade 3 gastrointestinal toxicity, hyperglycemia and/or fatigue despite the use of adequate/optimal medical intervention, 2) Any other >=Grade 3 toxicity not classified under CTCAE blood/bone marrow, or 3) Grade 4 neutropenia that persisted for >=7 consecutive days or was complicated by fever (defined as a body temperature >38.0 Celsius degree), 4) Grade 3 thrombocytopenia which needed blood transfusion or Grade 4 thrombocytopenia.
Overall safety profile [ Time Frame: End of study ]
Complete list of historical versions of study NCT00603538 on ClinicalTrials.gov Archive Site
  • Maximum Observed Concentration (Cmax) of CP-751,871 [ Time Frame: Cycles 1 and 4 at prior to dosing of CP-751,871 (Day 1), and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: Cycle 1 : prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Area Under the Plasma Concentration-time Curve From Time 0 to Day 22 (AUC0-day22) [ Time Frame: Cycle 1: prior CP-751,871 (Day 1) to dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion ]
    AUC(0-day22) : AUC from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sampling for the next cycle. AUC(0-day22) was calculated using the linear/log trapezoidal method.
  • Area Under the Plasma Concentration Curve From Time Zero to Tau (AUCtau) [ Time Frame: Cycle 4: prior to CP-751,871 (Day 1) dosing , and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion ]
    AUCtau: AUC from time zero to tau, the dosing interval, where tau is the actual time of the predose sampling for the next cycle. AUCtau was calculated using the linear/log trapezoidal method.
  • Observed Accumulation Ratio (Rac) [ Time Frame: Cycle 1 and Cycle 4: prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion ]
    The ratio of Cycle 4 AUCtau to Cycle 1 AUCtau
  • Serum Concentrations of Total Insulin-like Growth Factor 1 (IGF-1) [ Time Frame: Day 1 of Cycles 1 to 6, Day 8 of Cycles 1 to 4, and end of study ]
    IGF-1 is one of the IGF-axis related biomarkers.
  • Serum Concentrations of Total Insulin-like Growth Factor Binding Protein-3 (IGF-BP-3) [ Time Frame: Day 1 of Cycles 1-6, Day 8 of Cycles 1-4, and end of treatment ]
    IGF-BP3 is one of the IGF-axis related biomarkers.
  • Number of Participants With Positive Anti-Drug Antibody (ADA) Specific to CP-751,871 Following an Intravenous Infusion of CP-751,871. [ Time Frame: Day 1 of Cycles 1 (predose) and 4, and end of study ]
    The screening assay for anti-CP-751,871 antibodies was performed.
  • Number of Participants With Objective Response [ Time Frame: Baseline up to 6 cycles (1 cycle = 21 days) ]
    Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.
  • Progression-Free Survival (PFS) [ Time Frame: Baseline up to 6 cycles (1 cycle = 21 days) ]
    PFS is the period from the registration to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
  • Occurrence of anti-drug antibody [ Time Frame: End of study ]
  • Pharmacokinetics parameters [ Time Frame: End of study ]
  • Blood biomarkers [ Time Frame: End of study ]
  • Tumor responses [ Time Frame: End of study ]
Not Provided
Not Provided
 
Study of CP-751,871 in Combination With Carboplatin and Paclitaxel in Advanced Lung Cancer
Phase 1, Dose Escalation Study of CP-751,871 in Combination With Carboplatin and Paclitaxel in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer
Investigate safety, tolerability and pharmacokinetics of CP-751,871 when given in combination with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
Drug: CP-751,871 + carboplatin + paclitaxel
Chemotherapy (carboplatin and paclitaxel) and CP-751,871 (6, 10 or 20mg/kg) will be administered by intravenous infusion every three weeks.
Experimental: CP-751,871
Intervention: Drug: CP-751,871 + carboplatin + paclitaxel
Goto Y, Sekine I, Tanioka M, Shibata T, Tanai C, Asahina H, Nokihara H, Yamamoto N, Kunitoh H, Ohe Y, Kikkawa H, Ohki E, Tamura T. Figitumumab combined with carboplatin and paclitaxel in treatment-naïve Japanese patients with advanced non-small cell lung cancer. Invest New Drugs. 2012 Aug;30(4):1548-56. doi: 10.1007/s10637-011-9715-4. Epub 2011 Jul 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
May 2009
May 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of advanced non-small cell lung cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Any prior treatment for non-small cell lung cancer
  • Brain metastases
  • With diabetes
Sexes Eligible for Study: All
20 Years to 74 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00603538
A4021019
Japan CTPN 19-2409
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP