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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603538
• Other study ID #: A4021019
• Secondary ID: Japan CTPN 19-24
• Status: Completed
• Phase: Phase 1
• First received: January 17, 2008
• Last updated: March 5, 2013
• Start date: January 2008
• Est. completion date: May 2009

Study information

• Verified date: March 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

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.

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Chuo-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Dose Limiting Toxicities (DLT)	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.	Cycle 1	Yes
Secondary	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	No
Secondary	Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	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	No
Secondary	Area Under the Plasma Concentration-time Curve From Time 0 to Day 22 (AUC0-day22)	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.	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	No
Secondary	Area Under the Plasma Concentration Curve From Time Zero to Tau (AUCtau)	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.	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	No
Secondary	Observed Accumulation Ratio (Rac)	The ratio of Cycle 4 AUCtau to Cycle 1 AUCtau	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	No
Secondary	Serum Concentrations of Total Insulin-like Growth Factor 1 (IGF-1)	IGF-1 is one of the IGF-axis related biomarkers.	Day 1 of Cycles 1 to 6, Day 8 of Cycles 1 to 4, and end of study	No
Secondary	Serum Concentrations of Total Insulin-like Growth Factor Binding Protein-3 (IGF-BP-3)	IGF-BP3 is one of the IGF-axis related biomarkers.	Day 1 of Cycles 1-6, Day 8 of Cycles 1-4, and end of treatment	No
Secondary	Number of Participants With Positive Anti-Drug Antibody (ADA) Specific to CP-751,871 Following an Intravenous Infusion of CP-751,871.	The screening assay for anti-CP-751,871 antibodies was performed.	Day 1 of Cycles 1 (predose) and 4, and end of study	No
Secondary	Number of Participants With Objective Response	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.	Baseline up to 6 cycles (1 cycle = 21 days)	No
Secondary	Progression-Free Survival (PFS)	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.	Baseline up to 6 cycles (1 cycle = 21 days)	No

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