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

September 23, 2015 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

255

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil, 20231-050
        • Local Institution
      • Sao Paulo, Brazil, 05403-000
        • Local Institution
      • Sao Paulo, Brazil, 04024-002
        • Local Institution
    • Ceara
      • Fortaleza, Ceara, Brazil, 60336550
        • Local Institution
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
        • Local Institution
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
        • Local Institution
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784-400
        • Local Institution
  • France
      • Marseille Cedex 20, France, 13915
        • Local Institution
      • Paris, France, 75005
        • Local Institution
      • Rennes Cedex 9, France, 35033
        • Local Institution
      • Toulouse Cedex 9, France, 31059
        • Local Institution
      • Tours Cedex, France, 37044
        • Local Institution
  • Italy
      • Meldola (Fc), Italy, 47014
        • Local Institution
      • Ravenna, Italy, 48100
        • Local Institution
      • Rimini, Italy, 47900
        • Local Institution
      • Roma, Italy, 00189
        • Local Institution
      • Terni, Italy, 05100
        • Local Institution
  • Poland
      • Bialystok, Poland, 15-540
        • Local Institution
      • Gdansk, Poland, 80952
        • Local Institution
      • Otwock, Poland, 05-400
        • Local Institution
      • Poznan, Poland, 60 569
        • Local Institution
      • Szczecin, Poland, 70-891
        • Local Institution
      • Warsaw, Poland, 02-781
        • Local Institution
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454087
        • Local Institution
      • Ivanovo, Russian Federation, 153013
        • Local Institution
      • Moscow, Russian Federation, 115 478
        • Local Institution
      • Moscow, Russian Federation, 115478
        • Local Institution
      • Moscow, Russian Federation, 143423
        • Local Institution
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6045
        • Local Institution
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0002
        • Local Institution
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7570
        • Local Institution
      • Cape Town, Western Cape, South Africa, 7925
        • Local Institution
      • Rondebosch, Western Cape, South Africa, 7700
        • Local Institution
  • United Kingdom
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M23 9LT
        • Local Institution
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • Local Institution
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Acrc/Arizona Clinical Research Center, Inc.
    • California
      • San Diego, California, United States, 92123
        • Sharp Clinical Oncology Research
    • Florida
      • Orlando, Florida, United States, 32804
        • Cancer Institute Of Florida
      • West Palm Beach, Florida, United States, 33401
        • Palm Beach Cancer Institute
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Clintell, Inc.
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Kentucky Cancer Clinic
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Annapolis Oncology Center
      • Hagerstown, Maryland, United States, 21740
        • Meritus Center for Clinical Research
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Hematology And Oncology Associates, Ltd
    • North Carolina
      • Winston-salem, North Carolina, United States, 27103
        • Piedmont Hematology Oncology Associates, PLLC
    • Ohio
      • Canton, Ohio, United States, 44710
        • North Canton Medical Clinic Center
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Oncology/Hematology
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Clinic, Ltd
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Charleston Hematology Oncology Associates, PA
    • Tennessee
      • Cookeville, Tennessee, United States, 38501
        • Cancer Center At Cookeville Regional Medical Center
      • Memphis, Tennessee, United States, 38104
        • University of Tennessee Cancer Institute
    • Virginia
      • Christiansburg, Virginia, United States, 24073
        • Blue Ridge Cancer Care
    • Washington
      • Lacey, Washington, United States, 98503
        • Providence Western Washington Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Paclitaxel/Carboplatin/CT-322
Drug: Paclitaxel
Solution, IV, 200 mg/m2, Q21days, 6 cycles
Other Names:
  • Taxol
Drug: Carboplatin
Solution, IV, AUC=6, Q21days, 6 cycles
Other Names:
  • Paraplatin
Drug: CT-322
Solution, IV, 2 mg/kg, Q7days, Until PD
Other Names:
  • BMS-844203
Active Comparator: Paclitaxel/Carboplatin/Bevacizumab/Placebo
Drug: Paclitaxel
Solution, IV, 200 mg/m2, Q21days, 6 cycles
Other Names:
  • Taxol
Drug: Carboplatin
Solution, IV, AUC=6, Q21days, 6 cycles
Other Names:
  • Paraplatin
Drug: Bevacizumab
Solution, IV, 15 mg/kg, Q21days, Until PD
Other Names:
  • Avastin
Drug: Bevacizumab placebo (ie saline solution)
Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD
Other Names:
  • Saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival based on tumor assessments (CT scans/MRI)
Time Frame: every 6 weeks until documented progressive disease , death or initiation of subsequent therapy for NSCLC
every 6 weeks until documented progressive disease , death or initiation of subsequent therapy for NSCLC

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS) between 2 arms
Time Frame: every 12 weeks
every 12 weeks
Objective tumor response rate (ORR) between 2 arms
Time Frame: every 6 weeks
every 6 weeks
Safety in the CT-322 plus carboplatin and paclitaxel arm
Time Frame: weekly
weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

February 23, 2009

First Submitted That Met QC Criteria

February 23, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA196-005
  • EUDRACT# 2008-007768-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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