A Study Of Ranpirnase(Onconase®) To Pemetrexed Plus Carboplatin In Patients With Non-Squamous Non-Small Cell Lung Cancer

August 31, 2015 updated by: Tamir Biotechnology, Inc.

A Phase II Trial of Addition of Ranpirnase(ONCONASE®) to Permetrexed Plus Carboplatin in Patientes With Non-Squamous Non-Small Cell Lung Cancer

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Tower Cancer Research Foundation
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Van Andel Research Institute
    • Montana
      • Great Falls, Montana, United States, 59405
        • Sletten Cancer Specialists
    • New York
      • New York, New York, United States, 10016
        • The Cancer Institute at NYU Langone Medical Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Tri-county Hematology-Oncology Associates, Inc
    • Utah
      • Ogden, Utah, United States, 84403
        • Northern Utah Associates

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

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ranpirnase
All patients who do not progress after two cycles of pemetrexed-carboplatin will receive the study drug, ranpirnase
Drug: Ranpirnase
Cycles 3 and until patient progression, on days 1,8 and 15 in a 21 day cycle
Other Names:
  • Onconase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 or more months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years
Survival
Time Frame: 2 years
To determine the survival of patients with SD, PR or CR following 2 cycles of doublet chemotherapy
2 years

Collaborators and Investigators

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

Sponsor

Tamir Biotechnology, Inc.

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 Registration Dates

First Submitted

August 17, 2010

First Submitted That Met QC Criteria

August 17, 2010

First Posted (Estimate)

August 18, 2010

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P30-800

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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