Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated 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: NCT01160601
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Peregrine Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 8, 2010
First Posted Date  ICMJE July 12, 2010
Last Update Posted Date April 19, 2017
Study Start Date  ICMJE June 2010
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
Objective Response Rate [ Time Frame: Until disease progression ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2010)
Objective Response Rate [ Time Frame: Until disease progression ]
The primary objective of this study is to compare the objective response rate (ORR; complete response [CR] + partial response [PR]) of paclitaxel/carboplatin alone versus paclitaxel/carboplatin with bavituximab in patients with previously untreated locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC). Objective tumor response will be assessed using RECIST version 1.1.
Change History Complete list of historical versions of study NCT01160601 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer
Official Title  ICMJE A Randomized, Open-Label, Phase 2 Trial of Paclitaxel/Carboplatin With or Without Bavituximab in Patients With Previously Untreated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
Brief Summary This is a randomized, open-label, multicenter, phase 2 study comparing Paclitaxel/Carboplatin with or without bavituximab in patients that have previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Squamous Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Paclitaxel / Carboplatin
    Patients will receive commercially available paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles.
  • Drug: bavituximab
    Patients will receive 3 mg/kg bavituximab, administered weekly until progression or toxicity.
Study Arms  ICMJE
  • Experimental: paclitaxel/carboplatin plus bavituximab
    Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles, in combination with 3 mg/kg bavituximab administered weekly.
    Interventions:
    • Drug: Paclitaxel / Carboplatin
    • Drug: bavituximab
  • Active Comparator: paclitaxel/carboplatin
    Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles.
    Intervention: Drug: Paclitaxel / Carboplatin
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 Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2010)
86
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Adults over 18 years of age with a life expectancy of at least 3 months.
  • Histologically or cytologically confirmed stage IIIB or stage IV non-squamous NSCLC that has not been previously treated with systemic chemotherapy.
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).
  • Adequate hematologic, renal and hepatic function.
  • PT / INR ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN and D-dimer ≤ 3 × ULN.

Key Exclusion Criteria:

  • Squamous cell, small cell, or mixed histology.
  • Known history of bleeding diathesis or coagulopathy.
  • Cavitary tumors or tumors abutting large blood vessels.
  • Bleeding: Clinically significant bleeding, such as gross hematuria, GI bleeding and hemoptysis, within 12 months of Screening.
  • Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism) within 6 months of Screening.
  • Ongoing therapy with oral or parenteral anticoagulants.
  • Concurrent estrogens, anti-estrogens or progesterone compounds.
  • Grade 2 or higher peripheral neuropathy.
  • Radiotherapy within 2 weeks preceding Study Day 1.
  • Symptomatic or clinically active brain metastases.
  • Major surgery within 4 weeks of Study Day 1.
  • Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease).
  • Symptomatic coronary artery disease, cerebrovascular accident,transient ischemic attack, myocardial infarction, or unstable angina pectoris within 6 months of Screening.
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 Georgia,   India,   Russian Federation,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01160601
Other Study ID Numbers  ICMJE PPHM 1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peregrine Pharmaceuticals
Study Sponsor  ICMJE Peregrine Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peregrine Pharmaceuticals
Verification Date April 2017

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