Back to resultsA Study Of Ranpirnase(Onconase®) To Pemetrexed Plus Carboplatin In Patients With Non-Squamous Non-Small Cell Lung Cancer
Primary Purpose
Non-Small Cell Lung Cancer
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ranpirnase
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non Small Cell Lung Cancer, NSCLC, Lung Cancer, Previously untreated Non-Squamous, Non-Small Cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
- Tower Cancer Research Foundation
- Van Andel Research Institute
- Sletten Cancer Specialists
- The Cancer Institute at NYU Langone Medical Center
- Tri-county Hematology-Oncology Associates, Inc
- Northern Utah Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ranpirnase
Arm Description
All patients who do not progress after two cycles of pemetrexed-carboplatin will receive the study drug, ranpirnase
Outcomes
Primary Outcome Measures
Response
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
Secondary Outcome Measures
Progression Free Survival (PFS)
To determine the PFS in patients with SD, PR or CR following 2 cycles of doublet chemotherapy
Survival
To determine the survival of patients with SD, PR or CR following 2 cycles of doublet chemotherapy
Full Information
NCT ID
NCT01184287
First Posted
August 17, 2010
Last Updated
August 31, 2015
Sponsor
Tamir Biotechnology, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01184287
Brief Title
A Study Of Ranpirnase(Onconase®) To Pemetrexed Plus Carboplatin In Patients With Non-Squamous Non-Small Cell Lung Cancer
Official Title
A Phase II Trial of Addition of Ranpirnase(ONCONASE®) to Permetrexed Plus Carboplatin in Patientes With Non-Squamous Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Program discontinued
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Tamir Biotechnology, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Non Small Cell Lung Cancer, NSCLC, Lung Cancer, Previously untreated Non-Squamous, Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ranpirnase
Arm Type
Experimental
Arm Description
All patients who do not progress after two cycles of pemetrexed-carboplatin will receive the study drug, ranpirnase
Intervention Type
Drug
Intervention Name(s)
Ranpirnase
Other Intervention Name(s)
Onconase
Intervention Description
Cycles 3 and until patient progression, on days 1,8 and 15 in a 21 day cycle
Primary Outcome Measure Information:
Title
Response
Description
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
Time Frame
4 or more months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
To determine the PFS in patients with SD, PR or CR following 2 cycles of doublet chemotherapy
Time Frame
2 years
Title
Survival
Description
To determine the survival of patients with SD, PR or CR following 2 cycles of doublet chemotherapy
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tower Cancer Research Foundation
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Van Andel Research Institute
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Sletten Cancer Specialists
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
The Cancer Institute at NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Tri-county Hematology-Oncology Associates, Inc
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Northern Utah Associates
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study Of Ranpirnase(Onconase®) To Pemetrexed Plus Carboplatin In Patients With Non-Squamous Non-Small Cell Lung Cancer
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