Study of CP-751,871 in Combination With Carboplatin and Paclitaxel in Advanced Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00603538|
Recruitment Status : Completed
First Posted : January 29, 2008
Results First Posted : April 11, 2013
Last Update Posted : April 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: CP-751,871 + carboplatin + paclitaxel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||January 2008|
|Primary Completion Date :||May 2009|
|Study Completion Date :||May 2009|
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00603538
|Pfizer Investigational Site|
|Chuo-ku, Tokyo, Japan|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|