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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00850577
Recruitment Status : Terminated
First Posted : February 25, 2009
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE February 23, 2009
First Posted Date  ICMJE February 25, 2009
Last Update Posted Date October 12, 2015
Study Start Date  ICMJE June 2009
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00850577 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2009)
  • Overall survival (OS) between 2 arms [ Time Frame: every 12 weeks ]
  • Objective tumor response rate (ORR) between 2 arms [ Time Frame: every 6 weeks ]
  • Safety in the CT-322 plus carboplatin and paclitaxel arm [ Time Frame: weekly ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2009)
  • overall survival (OS) in each arm [ Time Frame: every 12 weeks ]
  • objective tumor response rate (ORR) in each arm [ Time Frame: every 6 weeks ]
  • duration of response in each of the two treatment arms [ Time Frame: every 6 weeks ]
  • time to response in each of the two treatment arms [ Time Frame: every 6 weeks ]
  • Safety in the CT-322 plus carboplatin and paclitaxel arm [ Time Frame: weekly ]
  • pharmacokinetics of CT-322 and paclitaxel when administered in combination [ Time Frame: at various timepoints ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ph II of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Treatment of Non-Small Cell Lung Cancer
Official Title  ICMJE 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
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer (NSCLC)
Intervention  ICMJE
  • Drug: Paclitaxel
    Solution, IV, 200 mg/m2, Q21days, 6 cycles
    Other Name: Taxol
  • Drug: Carboplatin
    Solution, IV, AUC=6, Q21days, 6 cycles
    Other Name: Paraplatin
  • Drug: CT-322
    Solution, IV, 2 mg/kg, Q7days, Until PD
    Other Name: BMS-844203
  • Drug: Bevacizumab
    Solution, IV, 15 mg/kg, Q21days, Until PD
    Other Name: 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 Name: Saline solution
Study Arms  ICMJE
  • Active Comparator: Paclitaxel/Carboplatin/CT-322
    Interventions:
    • Drug: Paclitaxel
    • Drug: Carboplatin
    • Drug: CT-322
  • Active Comparator: Paclitaxel/Carboplatin/Bevacizumab/Placebo
    Interventions:
    • Drug: Paclitaxel
    • Drug: Carboplatin
    • Drug: Bevacizumab
    • Drug: Bevacizumab placebo (ie saline solution)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 8, 2013)
255
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2009)
254
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   France,   Italy,   Poland,   Russian Federation,   South Africa,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00850577
Other Study ID Numbers  ICMJE CA196-005
EUDRACT# 2008-007768-41
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP