Clinical trial NCT00603538: Study of CP-751,871 in Combination With Carboplatin and Paclitaxel in Advanced Lung Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: CP-751,871, Non-small cell lung cancer, Phase 1
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-29
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicities (DLT)
timeFrame: Cycle 1
Secondary outcomes:
measure: Maximum Observed Concentration (Cmax) of CP-751,871
timeFrame: 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
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 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
measure: Area Under the Plasma Concentration-time Curve From Time 0 to Day 22 (AUC0-day22)
timeFrame: 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
measure: Area Under the Plasma Concentration Curve From Time Zero to Tau (AUCtau)
timeFrame: 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
measure: Observed Accumulation Ratio (Rac)
timeFrame: 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
measure: Serum Concentrations of Total Insulin-like Growth Factor 1 (IGF-1)
timeFrame: Day 1 of Cycles 1 to 6, Day 8 of Cycles 1 to 4, and end of study
measure: Serum Concentrations of Total Insulin-like Growth Factor Binding Protein-3 (IGF-BP-3)
timeFrame: Day 1 of Cycles 1-6, Day 8 of Cycles 1-4, and end of treatment
measure: Number of Participants With Positive Anti-Drug Antibody (ADA) Specific to CP-751,871 Following an Intravenous Infusion of CP-751,871.
timeFrame: Day 1 of Cycles 1 (predose) and 4, and end of study
measure: Number of Participants With Objective Response
timeFrame: Baseline up to 6 cycles (1 cycle = 21 days)
measure: Progression-Free Survival (PFS)
timeFrame: Baseline up to 6 cycles (1 cycle = 21 days)
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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-naive 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.