Renal Cell CancerPhase 2NCT00073112
A Study of ABT-751 in Patients With Renal Cell Cancer
A Phase 2 study testing ABT-751 in people with Renal Cell Cancer, run by Abbott at 23 sites in 2 countries.
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 renal cell 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
- Renal Cell Cancer
- What is being tested?
- ABT-751
- How many people
- 60 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Aug 2003to Sep 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
- Renal Cell Carcinoma.
- Recurrent tumor.
- At least 6 weeks post-nephrectomy.
- 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
23 sites in 2 countries.
23 sites in 2 countries
United States19 sites
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
US Oncology Inc Raleigh Hematology Oncology Clinic
Cary, North Carolina, 27511
University of Chicago Medical Center
Chicago, Illinois, 60637-1471
US Oncology Inc Rocky Mountain Cancer Centers
Denver, Colorado, 80218
US Oncology Inc Cancer Centers of the Carolinas
Greenville, South Carolina, 29615
US Oncology Inc Dayton Oncology & Hematology P.A.
Kettering, Ohio, 45409
UCLA School of Medicine
Los Angeles, California, 90024
West Cancer Clinic
Memphis, Tennessee, 38120
Oncology Hematology Group of South Florida
Miami, Florida
Clinical Trials + Research Associates
Montebello, California, 90640
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232-6307
US Oncology Inc Florida Cancer Institute
New Port Richey, Florida, 34652
US Oncology Inc Ocala Oncology Center
Ocala, Florida, 34474
US Oncology Inc Cancer Care Accociates-Mercy Campus
Oklahoma City, Oklahoma, 73120
US Oncology Inc Cancer Centers of Florida, P.A.
Orlando, Florida, 32806
US Oncology Inc Cancer Care Northwest-North
Spokane, Washington, 99218
Arizona Cancer Research Center
Tucson, Arizona, 85712
US Oncology Inc Tyler Cancer Center
Tyler, Texas, 75702
US Oncology Inc Northwest Cancer Specialists
Vancouver, Washington, 98684
Canada4 sites
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, B3H2Y9
McMaster University
Hamilton, Ontario, L8N 4A6
McGill University
Montreal, Quebec
B.C. Vancouver Cancer Agency
Vancouver, British Columbia, V5Z 4E6CAN
About this study
Official title: A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma
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 renal cell 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
- Renal Cell Cancer
- Being tested
- ABT-751
- Medical subject headings
- Carcinoma, Renal Cell
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 RCC
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 startAug 2003
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell 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
- 60 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Helen Eliopoulos, M.D., Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073112
- Sponsor's protocol ID
- M02-416
- 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 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT00073112
- Acronym / sponsor ID
- M02-416
- Conditions
- Renal Cell Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Study completion
- Sep 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 renal cell 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 (5 listed)
- Renal Cell Carcinoma.
- Recurrent tumor.
- At least 6 weeks post-nephrectomy.
- 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 RCC
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.
Related trials for Renal Cell Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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, M.D. study director
Abbott
23 sites in 2 countries: 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 Renal Cell Cancer, run by Abbott at 23 sites in 2 countries.
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 5 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 23 sites in United States, Canada. 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 RCC (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.