Advanced Renal Cell CarcinomaPhase 2NCT00486538
Study of ABT-869 in Subjects With Advanced Renal Cell Carcinoma Who Have Previously Received Treatment With Sunitinib
A Phase 2 study testing ABT-869 in people with Advanced Renal Cell Carcinoma, run by AbbVie (prior sponsor, Abbott) at 13 sites in 2 countries.
Trial summary
This study is designed to determine the clinical efficacy and toxicity of ABT 869 in the treatment of subjects with advanced renal cell carcinoma who have previously received treatment with sunitinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Renal Cell Carcinoma
- What is being tested?
- ABT-869
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Jun 2007to Jun 2012
- 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
- Subject has undergone previous nephrectomy.
- Subject has received at least 2 cycles (12 weeks) of treatment with sunitinib for RCC and stopped therapy due to progressive disease within 100 days prior to screening.
- Subject has measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by RECIST.
- ECOG Performance Score of 0-1.
- No history of another active cancer within the past 5 years.Life expectancy of at least 4 months.
- Willing to take adequate measures to prevent pregnancy.
Who cannot join
- Subject has received anti-cancer therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to study drug administration.
- Subject has untreated brain or meningeal metastases.
- Subject has received a tyrosine kinase inhibitor (TKI) other than sunitinib or sorafenib.
- Prior use of Avastin is allowed.
- The subject is receiving therapeutic anticoagulation therapy.
- The subject has a history of/or currently exhibits clinically significant cancer related events of bleeding (e.g., hematuria, hemoptysis).
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- The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) > 100 mmHg; or systolic blood pressure (BP) > 150 mmHg.
- The subject has a history of myocardial infarction within 6 months of Study Day 1.
- The subject has a documented left ventricular (LV) Ejection Fraction < 50%.
- The subject has known autoimmune disease with renal involvement (eg, Lupus).
- Female subjects who are pregnant or breast feeding.
- Subject is receiving anti-retroviral therapy for HIV.
- Subject has a clinically significant uncontrolled condition(s) including but not limited to:
- active uncontrolled infection,
- Class III or IV heart failure as defined by the New York Heart Association functional classification system,
- unstable angina pectoris or cardiac arrhythmia,
- history of adrenal insufficiency,
- psychiatric illness/social situation that would limit compliance with study requirements;
- Active, ulcerative colitis, Crohn's disease, celiadisease or any other conditions that interfere with absorption.
- Subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Site Reference ID/Investigator# 11662
Boston, Massachusetts, 02114
Site Reference ID/Investigator# 11663
Boston, Massachusetts, 02114
Site Reference ID/Investigator# 5379
Boston, Massachusetts, 02114
Site Reference ID/Investigator# 7300
Charleston, South Carolina, 29425
Site Reference ID/Investigator# 5384
Chicago, Illinois, 60637
Site Reference ID/Investigator# 6796
Houston, Texas, 77030-4009
Site Reference ID/Investigator# 5380
Lebanon, New Hampshire, 03756-0001
Site Reference ID/Investigator# 5249
Philadelphia, Pennsylvania, 19111
Site Reference ID/Investigator# 6278
Philadelphia, Pennsylvania, 19111
Site Reference ID/Investigator# 6269
Pittsburgh, Pennsylvania, 15232
Site Reference ID/Investigator# 7193
Sacramento, California, 95817
Site Reference ID/Investigator# 5243
Washington D.C., District of Columbia, 20010
About this study
Official title: An Open-Label, Phase 2 Study to Evaluate the Efficacy and Tolerability of ABT-869 in Subjects With Advanced Renal Cell Carcinoma (RCC) Who Have Previously Received Treatment With Sunitinib
This study is designed to determine the clinical efficacy and toxicity of ABT 869 in the treatment of subjects with advanced renal cell carcinoma who have previously received treatment with sunitinib.
- Conditions
- Advanced Renal Cell Carcinoma
- Being tested
- ABT-869
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-869Drug
One oral dose daily.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | One oral dose daily Receives: Drug: ABT-869 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: From randomization until patient death or alive at 2 years
Secondary outcomes (5)
Progression-free rate
Measured: Week 16
Best response rate
Measured: From randomization until patient death or alive at 2 years
Time to tumor progression
Measured: From randomization until patient death or alive at 2 years
Progression free survival
Measured: Radiographic evaluation every month, clinical evaluation every 4 weeks
Overall Survival
Measured: Two-year follow-up post study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Renal Cell CarcinomaStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Justin L. Ricker, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486538
- Sponsor's protocol ID
- M06-882
- Status last verified
- Jan 2013
- First submitted
- 12 Jun 2007
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Tannir NM, Wong YN, Kollmannsberger CK, Ernstoff MS, Perry DJ, Appleman LJ, Posadas EM, Cho D, Choueiri TK, Coates A, Gupta N, Pradhan R, Qian J, Chen J, Scappaticci FA, Ricker JL, Carlson DM, Michaelson MD. Phase 2 trial of linifanib (ABT-869) in patients with advanced renal cell cancer after sunitinib failure. Eur J Cancer. 2011 Dec;47(18):2706-14. doi: 10.1016/j.ejca.2011.09.002. Epub 2011 Nov 10.
PubMed 22078932
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 2 Study to Evaluate the Efficacy and Tolerability of ABT-869 in Subjects With Advanced Renal Cell Carcinoma (RCC) Who Have Previously Received Treatment With Sunitinib
- ClinicalTrials.gov ID
- NCT00486538
- Acronym / sponsor ID
- M06-882
- Conditions
- Advanced Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Jun 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Jun 2007 (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.
This study is designed to determine the clinical efficacy and toxicity of ABT 869 in the treatment of subjects with advanced renal cell carcinoma who have previously received treatment with sunitinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: ABT-869One oral dose daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has undergone previous nephrectomy.
- Subject has received at least 2 cycles (12 weeks) of treatment with sunitinib for RCC and stopped therapy due to progressive disease within 100 days prior to screening.
- Subject has measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by RECIST.
- ECOG Performance Score of 0-1.
- No history of another active cancer within the past 5 years.Life expectancy of at least 4 months.
Key exclusion criteria (20 listed)
- Subject has received anti-cancer therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to study drug administration.
- Subject has untreated brain or meningeal metastases.
- Subject has received a tyrosine kinase inhibitor (TKI) other than sunitinib or sorafenib.
- Prior use of Avastin is allowed.
- The subject is receiving therapeutic anticoagulation therapy.
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-869One oral dose daily. | Drug | Single arm |
Primary outcome
Objective Response Rate
Time frame: From randomization until patient death or alive at 2 years
5 secondary outcomes
Progression-free rate
Time frame: Week 16
Best response rate
Time frame: From randomization until patient death or alive at 2 years
Time to tumor progression
Time frame: From randomization until patient death or alive at 2 years
Progression free survival
Time frame: Radiographic evaluation every month, clinical evaluation every 4 weeks
Overall Survival
Time frame: Two-year follow-up post study
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 4 Jan 2013.
- Derived from this study: PubMed 22078932Tannir NM, Wong YN, Kollmannsberger CK, Ernstoff MS, Perry DJ, Appleman LJ, Posadas EM, Cho D, Choueiri TK, Coates A, Gupta N, Pradhan R, Qian J, Chen J, Scappaticci FA, Ricker JL, Carlson DM, Michaelson MD. Phase 2 trial of linifanib (ABT-869) in patients with advanced renal cell cancer after sunitinib failure. Eur J Cancer. 2011 Dec;47(18):2706-14. doi: 10.1016/j.ejca.2011.09.002. Epub 2011 Nov 10.
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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.
Justin L. Ricker, MD study director
AbbVie
13 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-869 in people with Advanced Renal Cell Carcinoma, run by AbbVie (prior sponsor, Abbott) at 13 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 6 inclusion and 20 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 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 (time frame: From randomization until patient death or alive at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00486538, which also lists 1 linked publication.
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 4 Jan 2013.