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

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:

A Randomized Double-Blinded Phase II Study of Carboplatin/Paclitaxel/CT-322 Versus Carboplatin/Paclitaxel/Bevacizumab as First-Line Treatment for Recurrent or Advanced Non-Small Cell Lung Cancer With Non-Squamous Histology

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00850577
• Other study ID #: CA196-005
• Secondary ID: EUDRACT# 2008-00
• Status: Terminated
• Phase: Phase 2
• First received: February 23, 2009
• Last updated: September 23, 2015
• Start date: June 2009
• Est. completion date: August 2013

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: National Institute of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationSouth Africa: Medicines Control CouncilSouth Africa: Department of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 255
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

• ECOG Performance Status (PS) <=1

• Histologically or cytologically confirmed, stage IIIB (malignant pleural effusion), stage IV or recurrent NSCLC

• Measurable disease by RECIST guidelines

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

Intervention

Drug:
• Paclitaxel
Solution, IV, 200 mg/m2, Q21days, 6 cycles
• Carboplatin
Solution, IV, AUC=6, Q21days, 6 cycles
• CT-322
Solution, IV, 2 mg/kg, Q7days, Until PD
• Bevacizumab
Solution, IV, 15 mg/kg, Q21days, Until PD
• Bevacizumab placebo (ie saline solution)
Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD

Locations

Country	Name	City	State
Brazil	Local Institution	Barretos	Sao Paulo
Brazil	Local Institution	Belo Horizonte	Minas Gerais
Brazil	Local Institution	Fortaleza	Ceara
Brazil	Local Institution	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution	Rio De Janeiro
Brazil	Local Institution	Sao Paulo
Brazil	Local Institution	Sao Paulo
France	Local Institution	Marseille Cedex 20
France	Local Institution	Paris
France	Local Institution	Rennes Cedex 9
France	Local Institution	Toulouse Cedex 9
France	Local Institution	Tours Cedex
Italy	Local Institution	Meldola (Fc)
Italy	Local Institution	Ravenna
Italy	Local Institution	Rimini
Italy	Local Institution	Roma
Italy	Local Institution	Terni
Poland	Local Institution	Bialystok
Poland	Local Institution	Gdansk
Poland	Local Institution	Otwock
Poland	Local Institution	Poznan
Poland	Local Institution	Szczecin
Poland	Local Institution	Warsaw
Russian Federation	Local Institution	Chelyabinsk
Russian Federation	Local institution	Ivanovo
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
South Africa	Local Institution	Cape Town	Western Cape
South Africa	Local Institution	Cape Town	Western Cape
South Africa	Local Institution	Port Elizabeth	Eastern Cape
South Africa	Local Institution	Pretoria	Gauteng
South Africa	Local Institution	Rondebosch	Western Cape
United Kingdom	Local Institution	Leeds	West Yorkshire
United Kingdom	Local Institution	Manchester	Greater Manchester
United States	Annapolis Oncology Center	Annapolis	Maryland
United States	North Canton Medical Clinic Center	Canton	Ohio
United States	Charleston Hematology Oncology Associates, Pa	Charleston	South Carolina
United States	Blue Ridge Cancer Care	Christiansburg	Virginia
United States	Cancer Center At Cookeville Regional Medical Center	Cookeville	Tennessee
United States	Meritus Center For Clinical Research	Hagerstown	Maryland
United States	Kentucky Cancer Clinic	Hazard	Kentucky
United States	Providence Western Washington Oncology	Lacey	Washington
United States	University Of Tennessee Cancer Institute	Memphis	Tennessee
United States	Cancer Institute Of Florida	Orlando	Florida
United States	Kaiser Permanente Oncology/Hematology	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Sharp Clinical Oncology Research	San Diego	California
United States	Guthrie Clinic, Ltd	Sayre	Pennsylvania
United States	Clintell, Inc.	Skokie	Illinois
United States	Acrc/Arizona Clinical Research Center, Inc.	Tucson	Arizona
United States	North Mississippi Hematology And Oncology Associates, Ltd	Tupelo	Mississippi
United States	Palm Beach Cancer Institute	West Palm Beach	Florida
United States	Cancer Center Of Kansas	Wichita	Kansas
United States	Piedmont Hematology Oncology Associates, Pllc	Winston-salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Brazil,  France,  Italy,  Poland,  Russian Federation,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival based on tumor assessments (CT scans/MRI)		every 6 weeks until documented progressive disease , death or initiation of subsequent therapy for NSCLC	No
Secondary	Overall survival (OS) between 2 arms		every 12 weeks	No
Secondary	Objective tumor response rate (ORR) between 2 arms		every 6 weeks	No
Secondary	Safety in the CT-322 plus carboplatin and paclitaxel arm		weekly	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form