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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00970580
First received: September 1, 2009
Last updated: September 12, 2013
Last verified: November 2011
  Purpose

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 Intervention Phase
Non-Small Cell Lung Cancer
Drug: BIIB022 With Paclitaxel and Carboplatin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatin [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Idec
  More Information

No publications provided

Responsible Party: Therese Senta-McMillian, Clinical Team Manager, PRA International
ClinicalTrials.gov Identifier: NCT00970580     History of Changes
Other Study ID Numbers: 212-LC-101
Study First Received: September 1, 2009
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Alkylating Agents
Antimitotic Agents
Paclitaxel
Carboplatin
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Mitosis Modulators
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 22, 2014