Advanced Non-small Cell Lung CancerPhase 2NCT00633789
Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types
A Phase 2 study testing brivanib in people with Advanced Non-small Cell Lung Cancer and Transitional Cell Carcinoma, run by Bristol-Myers Squibb at 25 sites in 9 countries.
Trial summary
The purpose of this study is to determine if gastric/esophageal, lung, pancreatic, bladder and sarcoma patients show benefit from brivanib treatment. Patients who clearly do, stay on treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer, Transitional Cell Carcinoma, Soft Tissue Sarcoma
- What is being tested?
- brivanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 597 participants
- Where
- 25 sitesin 9 countries
- Study dates
- Jun 2008to Dec 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
- Life expectancy at least 3 months
- Diagnosis of a solid tumor which is unresectable in which no approved effective therapy exists or for subjects who are intolerable to such therapy. The initial enrollment will focus on non-small cell lung, gastric/esophageal adenocarcinoma, soft tissue sarcoma, transitional cell carcinoma, and pancreatic cancer including ampulla of Vater tumors
- Adequate tumor sample
- Adequate recovery (baseline or Grade 1) from recent therapy. At least 1 week must have elapsed from the time of a minor surgery, and at least 8 weeks for major surgery or radiation therapy
Who cannot join
- Subjects with known brain metastasis.
- Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by CT or MRI
- Medical History and Concurrent Diseases:
- History of thrombo-embolic disease within the last six months requiring therapeutic anticoagulation
- Subjects with history of poor wound healing or non healing ulcers
- Uncontrolled or significant cardiovascular disease
Show all 12Show fewer
- Allergies and Adverse Drug Reactions:
- History of allergy to brivanib its drug class, or related compounds
- Prohibited Treatments and/or Therapies:
- Exposure to any investigational drug within 4 weeks of enrollment
- Other concurrent chemotherapy, hormonal therapy, immunotherapy regimens or radiotherapy, standard or investigational. Subjects may continue to receive hormone replacement therapy
- Prior exposure to brivanib
Trial locations and contacts
25 sites in 9 countries.
25 sites in 9 countries
United States6 sites
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, 21231
University Of Chicago
Chicago, Illinois, 60637
Northshore Univ. Healthsystem
Evanston, Illinois, 60201
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Cancer Ctr
New York, New York, 10065
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
Argentina4 sites
Local Institution
Buenos Aires, Buenos Aires, 1650
Local Institution
Capital Federal, Buenos Aires, 1264
Local Institution
Capital Federal, Buenos Aires, 1425
Local Institution
Capital Federal, Buenos Aires, 1426
Belgium3 sites
Local Institution
Brussels, 1000
Local Institution
Brussels, 1090
Local Institution
Brussels, 1200
Netherlands3 sites
Local Institution
Maastricht, 6202 AZ
Local Institution
Rotterdam, 3075 EA
Local Institution
Utrecht, 3508 GA
Canada2 sites
Local Institution
Edmonton, Alberta, T6G 1Z2
Local Institution
Toronto, Ontario, M5G 2M9
Germany2 sites
Local Institution
Freiburg im Breisgau, 79106
Local Institution
Halle, 06120
United Kingdom2 sites
Local Institution
Glasgow, Scotland, Strathclyde, GN11 6NT
Local Institution
Surrey, SM2 5PT
About this study
Official title: A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors
The purpose of this study is to determine if gastric/esophageal, lung, pancreatic, bladder and sarcoma patients show benefit from brivanib treatment. Patients who clearly do, stay on treatment. Those in which it is unclear will be randomized to continue or withdraw treatment to determine whether that benefit is related to brivanib
- Conditions
- Advanced Non-small Cell Lung Cancer, Transitional Cell Carcinoma, Soft Tissue Sarcoma, Gastric/Esophageal Adenocarcinoma, Pancreatic Cancer Including Ampulla of Vater
- Being tested
- brivanib, Placebo
- Medical subject headings
- Carcinoma, Transitional Cell, Sarcoma, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brivanibDrug
Also called BMS-582664
Tablets, Oral, 800 mg, once daily, until progression
PlaceboDrug
Tablets, Oral, 0 mg, once daily, until progression
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: brivanib |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic imaging and clinical evaluation will be used for tumor assessment
Measured: every 6 weeks
Secondary outcomes (6)
Safety profiles
Measured: ongoing throughout trial
Disease response rate
Measured: determined June 2010
Disease control rate
Measured: determined June 2010
Pharmacokinetics
Measured: determined June 2010
Pharmacodynamics
Measured: determined June 2010
Biomarkers
Measured: determined June 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2012
- Study completionDec 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 Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633789
- Sponsor's protocol ID
- CA182-026
- Status last verified
- Sep 2015
- First submitted
- 5 Mar 2008
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PubMed 37185961
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors
- ClinicalTrials.gov ID
- NCT00633789
- Acronym / sponsor ID
- CA182-026
- Conditions
- Advanced Non-small Cell Lung Cancer, Transitional Cell Carcinoma, Soft Tissue Sarcoma, Gastric/Esophageal Adenocarcinoma, Pancreatic Cancer Including Ampulla of Vater
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Mar 2008 (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 this study is to determine if gastric/esophageal, lung, pancreatic, bladder and sarcoma patients show benefit from brivanib treatment. Patients who clearly do, stay on treatment. Those in which it is unclear will be randomized to continue or withdraw treatment to determine whether that benefit is related to brivanib
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: brivanib |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Life expectancy at least 3 months
- Diagnosis of a solid tumor which is unresectable in which no approved effective therapy exists or for subjects who are intolerable to such therapy. The initial enrollment will focus on non-small cell lung, gastric/esophageal adenocarcinoma, soft tissue sarcoma, transitional cell carcinoma, and pancreatic cancer including ampulla of Vater tumors
- Adequate tumor sample
- Adequate recovery (baseline or Grade 1) from recent therapy. At least 1 week must have elapsed from the time of a minor surgery, and at least 8 weeks for major surgery or radiation therapy
Key exclusion criteria (12 listed)
- Subjects with known brain metastasis.
- Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by CT or MRI
- History of thrombo-embolic disease within the last six months requiring therapeutic anticoagulation
- Subjects with history of poor wound healing or non healing ulcers
- Uncontrolled or significant cardiovascular disease
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 |
|---|---|---|
| brivanibAlso: BMS-582664Tablets, Oral, 800 mg, once daily, until progression | Drug | 1 |
| PlaceboTablets, Oral, 0 mg, once daily, until progression | Drug | 2 |
Primary outcome
Radiographic imaging and clinical evaluation will be used for tumor assessment
Time frame: every 6 weeks
6 secondary outcomes
Safety profiles
Time frame: ongoing throughout trial
Disease response rate
Time frame: determined June 2010
Disease control rate
Time frame: determined June 2010
Pharmacokinetics
Time frame: determined June 2010
Pharmacodynamics
Time frame: determined June 2010
Biomarkers
Time frame: determined June 2010
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 9 Oct 2015.
- Derived from this study: PubMed 37185961Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
25 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing brivanib in people with Advanced Non-small Cell Lung Cancer and Transitional Cell Carcinoma, run by Bristol-Myers Squibb at 25 sites in 9 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 4 inclusion and 12 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 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Argentina, Belgium, Netherlands, Canada and 4 more countries. 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. Some participants in this study may receive a placebo. 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?
Radiographic imaging and clinical evaluation will be used for tumor assessment (time frame: every 6 weeks). 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 NCT00633789, 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 9 Oct 2015.