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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

CP-751,871 + carboplatin + paclitaxel

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring CP-751,871, Non-small cell lung cancer, Phase 1

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CP-751,871

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Maximum Observed Concentration (Cmax) of CP-751,871

Plasma Decay Half-Life (t1/2)

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)

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)

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)

The ratio of Cycle 4 AUCtau to Cycle 1 AUCtau

Serum Concentrations of Total Insulin-like Growth Factor 1 (IGF-1)

IGF-1 is one of the IGF-axis related biomarkers.

Serum Concentrations of Total Insulin-like Growth Factor Binding Protein-3 (IGF-BP-3)

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.

The screening assay for anti-CP-751,871 antibodies was performed.

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.

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.

Full Information

NCT ID

NCT00603538

First Posted

January 17, 2008

Last Updated

March 5, 2013

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00603538

Brief Title

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

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung

Keywords

CP-751,871, Non-small cell lung cancer, Phase 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CP-751,871

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

CP-751,871 + carboplatin + paclitaxel

Intervention Description

Chemotherapy (carboplatin and paclitaxel) and CP-751,871 (6, 10 or 20mg/kg) will be administered by intravenous infusion every three weeks.

Primary Outcome Measure Information:

Title

Number of Participants With Dose Limiting Toxicities (DLT)

Description

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.

Time Frame

Cycle 1

Secondary Outcome Measure Information:

Title

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

Title

Plasma Decay Half-Life (t1/2)

Description

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

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

Title

Area Under the Plasma Concentration-time Curve From Time 0 to Day 22 (AUC0-day22)

Description

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.

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

Title

Area Under the Plasma Concentration Curve From Time Zero to Tau (AUCtau)

Description

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.

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

Title

Observed Accumulation Ratio (Rac)

Description

The ratio of Cycle 4 AUCtau to Cycle 1 AUCtau

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

Title

Serum Concentrations of Total Insulin-like Growth Factor 1 (IGF-1)

Description

IGF-1 is one of the IGF-axis related biomarkers.

Time Frame

Day 1 of Cycles 1 to 6, Day 8 of Cycles 1 to 4, and end of study

Title

Serum Concentrations of Total Insulin-like Growth Factor Binding Protein-3 (IGF-BP-3)

Description

IGF-BP3 is one of the IGF-axis related biomarkers.

Time Frame

Day 1 of Cycles 1-6, Day 8 of Cycles 1-4, and end of treatment

Title

Number of Participants With Positive Anti-Drug Antibody (ADA) Specific to CP-751,871 Following an Intravenous Infusion of CP-751,871.

Description

The screening assay for anti-CP-751,871 antibodies was performed.

Time Frame

Day 1 of Cycles 1 (predose) and 4, and end of study

Title

Number of Participants With Objective Response

Description

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.

Time Frame

Baseline up to 6 cycles (1 cycle = 21 days)

Title

Progression-Free Survival (PFS)

Description

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.

Time Frame

Baseline up to 6 cycles (1 cycle = 21 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Chuo-ku

State/Province

Tokyo

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

21748299

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.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4021019&StudyName=Study%20of%20CP-751%2C871%20in%20Combination%20with%20Carboplatin%20and%20Paclitaxel%20in%20Advanced%20Lung%20Cancer

Description

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Carcinoma, Non-Small-Cell Lung

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial