Non-Small Cell Lung CancerPhase 2NCT00073151
A Study of ABT-751 in Patients With Non-Small Cell Lung Cancer
A Phase 2 study testing ABT-751 in people with Non-Small Cell Lung Cancer, run by Abbott at 17 sites in United States.
Trial summary
The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with non-small cell lung cancer. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug. 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?
- ABT-751
- How many people
- 30 participants
- Where
- 17 sitesUnited States
- Study dates
- Sep 2003to Jan 2006
- 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
- Stage IIIB or IV non-small cell lung cancer.
- Recurrent tumor following treatment with paclitaxel or docetaxel.
- Able to tolerate normal activities of daily living.
- Adequate bone marrow, kidney and liver function.
Who cannot join
- Pregnant or breast feeding.
- Anti-tumor therapy within 4 weeks of the start of ABT-751 administration.
- CNS metastasis.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Albany Regional Cancer Center
Albany, New York
University of Maryland Greenbaum Cancer Center
Baltimore, Maryland, 21201-1595
Raleigh Hematology Oncology
Cary, North Carolina
University of Chicago Medical Center
Chicago, Illinois, 60637-1460
Texas Oncology
Dallas, Texas
Texas Oncology
Fort Worth, Texas
Cancer Centers of the Carolinas
Greenville, South Carolina
Oncology & Hematology Associates of Kansas City, PA
Kansas City, Missouri, 64111
Dayton Oncology and Hematology
Kettering, Ohio
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-5666
West Cancer Clinic
Memphis, Tennessee, 38120
Oncology Hematology Group of South Florida
Miami, Florida
Florida Cancer Institute
New Port Richey, Florida
Cancer Care Associates
Oklahoma City, Oklahoma
Cancer Care Northwest
Spokane, Washington
Washington University School of Medicine
St Louis, Missouri, 63110-1093
Northwest Cancer Specialists
Vancouver, Washington
About this study
Official title: A Phase II Study of ABT-751 in Patients With Non-Small Cell Lung Cancer Refractory to Taxane Regimens
The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with non-small cell lung cancer. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- ABT-751
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-751Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate in subjects with NSCLC
Measured: 1 year
Secondary outcomes (3)
Time to Tumor Progression (TTP)
Measured: 1 year
Survival
Measured: 2 years
Toxicities associated with treatment administration
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2003 (estimated)
- Study startSep 2003
- Study completionJan 2006
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Helen Eliopoulos, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073151
- Sponsor's protocol ID
- M02-448
- Status last verified
- Nov 2007
- First submitted
- 17 Nov 2003
- Last updated
- 29 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of ABT-751 in Patients With Non-Small Cell Lung Cancer Refractory to Taxane Regimens
- ClinicalTrials.gov ID
- NCT00073151
- Acronym / sponsor ID
- M02-448
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Jan 2006 (actual)
- First posted
- 18 Nov 2003 (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 study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with non-small cell lung cancer. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage IIIB or IV non-small cell lung cancer.
- Recurrent tumor following treatment with paclitaxel or docetaxel.
- Able to tolerate normal activities of daily living.
- Adequate bone marrow, kidney and liver function.
Key exclusion criteria (3 listed)
- Pregnant or breast feeding.
- Anti-tumor therapy within 4 weeks of the start of ABT-751 administration.
- CNS metastasis.
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 |
|---|---|---|
| ABT-751 | Drug | – |
Primary outcome
Objective Response Rate in subjects with NSCLC
Time frame: 1 year
3 secondary outcomes
Time to Tumor Progression (TTP)
Time frame: 1 year
Survival
Time frame: 2 years
Toxicities associated with treatment administration
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2007.
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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.
Helen Eliopoulos, MD study director
Abbott
17 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 ABT-751 in people with Non-Small Cell Lung Cancer, run by Abbott at 17 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 29 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective Response Rate in subjects with NSCLC (time frame: 1 year). 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 29 Nov 2007.