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A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer

NCT ID: NCT00970580

Last Updated: 2013-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-09-30

Brief Summary

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The purpose of this study is to determine whether BIIB022, Paclitaxel and Carboplatin are effective in the treatment of Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Keywords

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BIIB022 Stage IV Taxol Stage IIIB Carboplatin Paclitaxel Non Small Cell Lung Cancer Treatment Naive Anti IGF1R NSCLC Open Label IGF1R Paraplatin Cytotoxic Mitotic Inhibitor Taxane Alkylating agent

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BIIB022 in Combination with Paclitaxel and Carboplatin

BIIB022 in Combination with Paclitaxel and Carboplatin

Group Type EXPERIMENTAL

BIIB022 With Paclitaxel and Carboplatin

Intervention Type DRUG

Escalating doses of BIIB022 with fixed dose and schedule of paclitaxel and carboplatin

Interventions

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BIIB022 With Paclitaxel and Carboplatin

Escalating doses of BIIB022 with fixed dose and schedule of paclitaxel and carboplatin

Intervention Type DRUG

Other Intervention Names

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Taxol Paraplatin BIIB022 Taxane Anti-IGF-1R Cytotoxic Mitotic Inhibitor IGF-1R Alkylating agent

Eligibility Criteria

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Inclusion Criteria

* Age \>/= 18 years old
* Treatment-naive Stage IIIB/IV Non-Small Cell Lung Cancer
* ECOG Performance Status 0 or 1

Exclusion Criteria

* History of another primary cancer within 3 years
* Any prior or concurrent investigational or standard therapy for treatment of NSCLC
* Prior anti-IGF-1R therapy
* Unstable diabetes
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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PRA International

Locations

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Resesarch Site

Los Angeles, California, United States

Site Status

Resesarch Site

San Diego, California, United States

Site Status

Resesarch Site

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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212-LC-101

Identifier Type: -

Identifier Source: org_study_id