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WithdrawnNCT01184287Updated Sep 2, 2015

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

A Phase 2 interventional study of Ranpirnase in Non-Small Cell Lung Cancer, sponsored by Tamir Biotechnology, Inc.. Withdrawn at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-02.

Sponsored by Tamir Biotechnology, Inc. · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Program discontinued
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • Non Small Cell Lung Cancer, NSCLC, Lung Cancer
  • Previously untreated Non-Squamous, Non-Small Cell Lung Cancer
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Tamir Biotechnology, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    ranpirnase

    All patients who do not progress after two cycles of pemetrexed-carboplatin will receive the study drug, ranpirnase

    Drug: Ranpirnase

Interventions

  • DrugRanpirnase

    Cycles 3 and until patient progression, on days 1,8 and 15 in a 21 day cycle

    Also known as: Onconase

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 4 or more months

Secondary outcomes

  1. Progression Free Survival (PFS)

    To determine the PFS in patients with SD, PR or CR following 2 cycles of doublet chemotherapy

    Time frame: 2 years

  2. Survival

    To determine the survival of patients with SD, PR or CR following 2 cycles of doublet chemotherapy

    Time frame: 2 years

07

Study locations

6 sites
  • Tower Cancer Research Foundation
    Beverly Hills, California 90211, United States
  • Van Andel Research Institute
    Grand Rapids, Michigan 49503, United States
  • Sletten Cancer Specialists
    Great Falls, Montana 59405, United States
  • The Cancer Institute at NYU Langone Medical Center
    New York, New York 10016, United States
  • Tri-county Hematology-Oncology Associates, Inc
    Canton, Ohio 44718, United States
  • Northern Utah Associates
    Ogden, Utah 84403, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01184287
Lead sponsor
Tamir Biotechnology, Inc.
First posted
Aug 18, 2010
Last update
Sep 2, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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Tamir Biotechnology, Inc.

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