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

Phase 1

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: CP-751,871 + carboplatin + paclitaxel

• Registration Number: NCT00603538
• Lead Sponsor: Pfizer

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-17
• Study First Submitted QC: 2008-01-17
• Study First Posted: 2008-01-29
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2013-01-18
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-05
• Last Update Submitted: 2013-03-05
• Results First Posted: 2013-04-11
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

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

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Exclusion Criteria

• Any prior treatment for non-small cell lung cancer
• Brain metastases
• With diabetes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CP-751,871	CP-751,871 + carboplatin + paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Dose Limiting Toxicities (DLT)	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.

Secondary Outcome Measures

Name	Time	Method
Maximum Observed Concentration (Cmax) of CP-751,871	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)	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)	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)	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)	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)	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)	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.	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	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)	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Chuo-ku, Tokyo, Japan