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

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ClinicalTrials.gov Identifier: NCT00970580
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : September 16, 2013
Sponsor:
Information provided by:
Biogen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: BIIB022 With Paclitaxel and Carboplatin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b, Open-Label, Dose-Escalation Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer
Study Start Date : October 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BIIB022 in Combination with Paclitaxel and Carboplatin
BIIB022 in Combination with Paclitaxel and Carboplatin
Drug: BIIB022 With Paclitaxel and Carboplatin
Escalating doses of BIIB022 with fixed dose and schedule of paclitaxel and carboplatin
Other Names:
  • Taxol
  • Paraplatin
  • BIIB022
  • Taxane
  • Anti-IGF-1R
  • Cytotoxic
  • Mitotic Inhibitor
  • IGF-1R
  • Alkylating agent



Primary Outcome Measures :
  1. To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatin [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970580


Locations
United States, California
Resesarch Site
Los Angeles, California, United States
Resesarch Site
San Diego, California, United States
United States, Colorado
Resesarch Site
Denver, Colorado, United States
Sponsors and Collaborators
Biogen

Responsible Party: Therese Senta-McMillian, Clinical Team Manager, PRA International
ClinicalTrials.gov Identifier: NCT00970580     History of Changes
Other Study ID Numbers: 212-LC-101
First Posted: September 2, 2009    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: November 2011

Keywords provided by Biogen:
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Antimitotic Agents
Taxane
Albumin-Bound Paclitaxel
Carboplatin
Mecasermin
Alkylating Agents
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Immunologic Factors