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A Study Of Ranpirnase(Onconase®) To Pemetrexed Plus Carboplatin In Patients With Non-Squamous 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: NCT01184287
Recruitment Status : Withdrawn (Program discontinued)
First Posted : August 18, 2010
Last Update Posted : September 2, 2015
Sponsor:
Information provided by:
Tamir Biotechnology, Inc.

Tracking Information
First Submitted Date  ICMJE August 17, 2010
First Posted Date  ICMJE August 18, 2010
Last Update Posted Date September 2, 2015
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2010)
Response [ Time Frame: 4 or more months ]
To determine the rate of improvement in objective tumor response, following the addition of ranpirnase to ongoing pemetrexed-carboplatin chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2015)
  • Progression Free Survival (PFS) [ Time Frame: 2 years ]
    To determine the PFS in patients with SD, PR or CR following 2 cycles of doublet chemotherapy
  • Survival [ Time Frame: 2 years ]
    To determine the survival of patients with SD, PR or CR following 2 cycles of doublet chemotherapy
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2010)
PFS [ Time Frame: 2 years ]
To determine the following in patients with SD, PR or CR following 2 cycles of doublet chemotherapy
  • Progression free survival
  • Survival-2 year
  • Change in ECOG Performance Status
  • Safety Profile of study treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Of Ranpirnase(Onconase®) To Pemetrexed Plus Carboplatin In Patients With Non-Squamous Non-Small Cell Lung Cancer
Official Title  ICMJE A Phase II Trial of Addition of Ranpirnase(ONCONASE®) to Permetrexed Plus Carboplatin in Patientes With Non-Squamous Non-Small Cell Lung Cancer
Brief Summary The purpose of the trial is to determine the rate of improvement in objective tumor response, following the addition of ranpirnase to ongoing pemetrexed-carboplatin chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE Drug: Ranpirnase
Cycles 3 and until patient progression, on days 1,8 and 15 in a 21 day cycle
Other Name: Onconase
Study Arms  ICMJE Experimental: ranpirnase
All patients who do not progress after two cycles of pemetrexed-carboplatin will receive the study drug, ranpirnase
Intervention: Drug: Ranpirnase
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 25, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2010)
70
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age greater than 18 years
  • ECOG less than 2
  • Estimated survival of greater than 12 weeks

Exclusion Criteria:

  • Prior systemic chemotherapy for locally advanced or metastatic NSCLC
  • Use of any investigational agent within 28 days prior to registration
  • Known hypersensitivity to any of the study drugs
  • Brain metastases or leptomeningeal disease
  • History of prior malignancy within the past three years
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01184287
Other Study ID Numbers  ICMJE P30-800
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Charles Muniz, Tamir Biotechnology, Inc.
Study Sponsor  ICMJE Tamir Biotechnology, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tamir Biotechnology, Inc.
Verification Date August 2015

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