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

NCT00970580 | Completed Phase 1 DMC

• 1 other identifier: 212-LC-101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatin

  6 months

Study Arms (1)

BIIB022 in Combination with Paclitaxel and Carboplatin

EXPERIMENTAL

BIIB022 in Combination with Paclitaxel and Carboplatin

Drug: BIIB022 With Paclitaxel and Carboplatin

Interventions

BIIB022 With Paclitaxel and Carboplatin DRUG

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

Also known as: Taxol, Paraplatin, BIIB022, Taxane, Anti-IGF-1R, Cytotoxic, Mitotic Inhibitor, IGF-1R, Alkylating agent

BIIB022 in Combination with Paclitaxel and Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (3)

Resesarch Site

Los Angeles, California, United States

Location

Resesarch Site

San Diego, California, United States

Location

Resesarch Site

Denver, Colorado, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

BIIB022; Paclitaxel; Carboplatin; taxane; cixutumumab; Cytotoxins; Antimitotic Agents; Receptor Protein-Tyrosine Kinases; Alkylating Agents

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Noxae; Toxic Actions; Chemical Actions and Uses; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Antineoplastic Agents; Therapeutic Uses; Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 2, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 16, 2013

Record last verified: 2011-11

Locations

US (3)