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

NCT ID: NCT00603538

Last Updated: 2013-04-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-05-31

Brief Summary

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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

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CP-751,871

Group Type EXPERIMENTAL

CP-751,871 + carboplatin + paclitaxel

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Chuo-ku, Tokyo, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 21748299 (View on PubMed)

Related Links

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Other Identifiers

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Japan CTPN 19-2409

Identifier Type: -

Identifier Source: secondary_id

A4021019

Identifier Type: -

Identifier Source: org_study_id

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