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Withdrawn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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small Cell Lung Cancer | Drug: Ranpirnase | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

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 Name: Onconase |
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184287
United States, California | |
Tower Cancer Research Foundation | |
Beverly Hills, California, United States, 90211 | |
United States, Michigan | |
Van Andel Research Institute | |
Grand Rapids, Michigan, United States, 49503 | |
United States, Montana | |
Sletten Cancer Specialists | |
Great Falls, Montana, United States, 59405 | |
United States, New York | |
The Cancer Institute at NYU Langone Medical Center | |
New York, New York, United States, 10016 | |
United States, Ohio | |
Tri-county Hematology-Oncology Associates, Inc | |
Canton, Ohio, United States, 44718 | |
United States, Utah | |
Northern Utah Associates | |
Ogden, Utah, United States, 84403 |
Responsible Party: | Charles Muniz, Tamir Biotechnology, Inc. |
ClinicalTrials.gov Identifier: | NCT01184287 |
Other Study ID Numbers: |
P30-800 |
First Posted: | August 18, 2010 Key Record Dates |
Last Update Posted: | September 2, 2015 |
Last Verified: | August 2015 |
Non Small Cell Lung Cancer, NSCLC, Lung Cancer Previously untreated Non-Squamous, Non-Small Cell Lung Cancer |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Ranpirnase Antineoplastic Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |