Ph II of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Treatment of Non-Small Cell Lung Cancer

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Non-small Cell Lung Cancer (NSCLC)

In brief

The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects with recurrent or advanced non-squamous NSCLC

Key facts

Study ID

NCT00850577

Run by

Bristol-Myers Squibb

People needed

255

Starts

2009-06-01

Expected to finish

2013-08-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ECOG Performance Status (PS) <=1
• Histologically or cytologically confirmed, stage IIIB (malignant pleural effusion), stage IV or recurrent NSCLC
• Measurable disease by RECIST guidelines

You may not qualify if…

• Evidence of predominantly squamous-cell histology
• Known CNS metastases
• Any prior antineoplastic systemic regimens for NSCLC
• Excessive risk of bleeding (including use of therapeutic anticoagulation) and history of thrombotic or embolic cerebrovascular accident
• Gross hemoptysis (≥1/2 tsp of red blood)
• Uncontrolled hypertension
• Clinically significant cardiovascular disease
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis

Where it is running

• Sharp Clinical Oncology Research — San Diego, California, United States
• Cancer Institute Of Florida — Orlando, Florida, United States
• Palm Beach Cancer Institute — West Palm Beach, Florida, United States
• Clintell, Inc. — Skokie, Illinois, United States
• Cancer Center Of Kansas — Wichita, Kansas, United States
• Kentucky Cancer Clinic — Hazard, Kentucky, United States
• Annapolis Oncology Center — Annapolis, Maryland, United States
• Meritus Center For Clinical Research — Hagerstown, Maryland, United States
• North Mississippi Hematology And Oncology Associates, Ltd — Tupelo, Mississippi, United States
• Piedmont Hematology Oncology Associates, Pllc — Winston-Salem, North Carolina, United States
• North Canton Medical Clinic Center — Canton, Ohio, United States
• Kaiser Permanente Oncology/Hematology — Portland, Oregon, United States
• Guthrie Clinic, Ltd — Sayre, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Charleston Hematology Oncology Associates, Pa — Charleston, South Carolina, United States
• Cancer Center At Cookeville Regional Medical Center — Cookeville, Tennessee, United States
• University Of Tennessee Cancer Institute — Memphis, Tennessee, United States
• Blue Ridge Cancer Care — Christiansburg, Virginia, United States
• Providence Western Washington Oncology — Lacey, Washington, United States
• Local Institution — Fortaleza, Ceará, Brazil
• Local Institution — Belo Horizonte, Minas Gerais, Brazil
• Local Institution — Rio de Janeiro, Rio de Janeiro, Brazil
• Local Institution — Porto Alegre, Rio Grande do Sul, Brazil
• Local Institution — Barretos, São Paulo, Brazil
• Acrc/Arizona Clinical Research Center, Inc. — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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