Non-Small Cell Lung CancerPhase 2NCT01184287
A Study Of Ranpirnase(Onconase®) To Pemetrexed Plus Carboplatin In Patients With Non-Squamous Non-Small Cell Lung Cancer
A Phase 2 study testing Ranpirnase in people with Non-Small Cell Lung Cancer, run by Tamir Biotechnology, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Ranpirnase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- ECOG less than 2
- Estimated survival of greater than 12 weeks
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Tower Cancer Research Foundation
Beverly Hills, California, 90211
Tri-county Hematology-Oncology Associates, Inc
Canton, Ohio, 44718
Van Andel Research Institute
Grand Rapids, Michigan, 49503
Sletten Cancer Specialists
Great Falls, Montana, 59405
The Cancer Institute at NYU Langone Medical Center
New York, New York, 10016
Northern Utah Associates
Ogden, Utah, 84403
About this study
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
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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Ranpirnase
- Keywords
- Non Small Cell Lung Cancer, NSCLC, Lung Cancer, Previously untreated Non-Squamous, Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanpirnaseDrug
Also called Onconase
Cycles 3 and until patient progression, on days 1,8 and 15 in a 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| ranpirnase | Experimental | All patients who do not progress after two cycles of pemetrexed-carboplatin will receive the study drug, ranpirnase Receives: Drug: Ranpirnase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 or more months
Secondary outcomes (2)
Progression Free Survival (PFS)
To determine the PFS in patients with SD, PR or CR following 2 cycles of doublet chemotherapy
Measured: 2 years
Survival
To determine the survival of patients with SD, PR or CR following 2 cycles of doublet chemotherapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
Why it stopped: Program discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tamir Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184287
- Sponsor's protocol ID
- P30-800
- Status last verified
- Aug 2015
- First submitted
- 17 Aug 2010
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01184287
- Acronym / sponsor ID
- P30-800
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non Small Cell Lung Cancer, NSCLC, Lung Cancer, Previously untreated Non-Squamous, Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Program discontinued
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tamir Biotechnology, Inc.Industry (pharma, biotech, devices)
- First posted
- 18 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ranpirnase | Experimental | Drug: RanpirnaseAll patients who do not progress after two cycles of pemetrexed-carboplatin will receive the study drug, ranpirnase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 18 years
- ECOG less than 2
- Estimated survival of greater than 12 weeks
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanpirnaseAlso: OnconaseCycles 3 and until patient progression, on days 1,8 and 15 in a 21 day cycle | Drug | ranpirnase |
Primary outcome
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
2 secondary outcomes
Progression Free Survival (PFS)
Time frame: 2 years
Survival
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ranpirnase in people with Non-Small Cell Lung Cancer, run by Tamir Biotechnology, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response (time frame: 4 or more months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.