TumorsPhase 1NCT00207103
MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study testing Brivanib and Brivanab in people with Tumors and Neoplasm Metastasis, run by Bristol-Myers Squibb at 8 sites in 4 countries.
Trial summary
This is a Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors, Neoplasm Metastasis
- What is being tested?
- Brivanib and Brivanab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Sep 2004to Sep 2008
- Phase
- Phase 1
- 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
- Diagnosis of progressive advanced or metastatic (tumor that has spread) solid tumors
- No tumor spread to the brain
- Feeling well other than cancer diagnosis (i.e. lab work, no infection, etc.)
- Available tumor tissue sample from prior surgery
- 4-6 weeks since prior therapy and recovered from prior therapy
- Men and women, ages 18 and above
Show all 9Show fewer
- Women must not be pregnant or breastfeeding
- Diagnosis of advanced or metastatic (tumor that has spread) colorectal, hepatocellular (liver) or renal (kidney) cancer
- Measurable disease on scans (at least one)
Who cannot join
None listed.
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States3 sites
Indiana University Med Center
Indianapolis, Indiana, 46202
University Of Wisconsin Comprehensive Center
Madison, Wisconsin, 53792
Premiere Oncology
Santa Monica, California, 90404
Canada2 sites
Local Institution
Edmonton, Alberta, T6G 1Z2
Local Institution
Ottawa, Ontario, K1H 1C4
United Kingdom2 sites
Local Institution
Manchester, Greater Manchester, M20 4BX
Local Institution
Middlesex, Greater London, HA6 2RN
About this study
Official title: Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
This is a Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.
- Conditions
- Tumors, Neoplasm Metastasis
- Being tested
- Brivanib, Brivanab
- Keywords
- Advanced metastatic or solid tumors
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
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, 180 mg, once daily, until disease progression
BrivanibDrug
Also called BMS-582664
Tablets, Oral, 320 mg, once daily, until disease progression
BrivanibDrug
Also called BMS-582664
Tablets, Oral, 600 mg, once daily, until disease progression
BrivanibDrug
Also called BMS-582664
Tablets, Oral, 800 mg, once daily, until disease progression
BrivanibDrug
Also called BMS-582664
Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression
BrivanabDrug
Also called BMS-582664
Tablets, Oral, 1000 mg, once daily, until disease progression
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Brivanib |
| 2 | Experimental | Not described Receives: Drug: Brivanib |
| 3 | Experimental | Not described Receives: Drug: Brivanib |
| 4 | Experimental | Not described Receives: Drug: Brivanib |
| 5 | Experimental | Not described Receives: Drug: Brivanib |
| 6 | Experimental | Not described Receives: Drug: Brivanab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment
Measured: throughout the study
dose-limiting toxicity (DLT)
Measured: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified
determination of maximum tolerated dose (MTD)
Measured: during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified
Secondary outcomes (1)
Efficacy based on duration of response and time to progression based on assessment
Measured: measured every 8 weeks throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionOct 2007
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207103
- Sponsor's protocol ID
- CA182-002
- Status last verified
- Nov 2008
- First submitted
- 12 Sep 2005
- Last updated
- 4 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT00207103
- Acronym / sponsor ID
- CA182-002
- Conditions
- Tumors, Neoplasm Metastasis
- Keywords
- Advanced metastatic or solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 21 Sep 2005 (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 is a Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Brivanib |
| 2 | Experimental | Drug: Brivanib |
| 3 | Experimental | Drug: Brivanib |
| 4 | Experimental | Drug: Brivanib |
| 5 | Experimental | Drug: Brivanib |
| 6 | Experimental | Drug: Brivanab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of progressive advanced or metastatic (tumor that has spread) solid tumors
- No tumor spread to the brain
- Feeling well other than cancer diagnosis (i.e. lab work, no infection, etc.)
- Available tumor tissue sample from prior surgery
- 4-6 weeks since prior therapy and recovered from prior therapy
Key exclusion criteria (0 listed)
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, 180 mg, once daily, until disease progression | Drug | 1 |
| BrivanibAlso: BMS-582664Tablets, Oral, 320 mg, once daily, until disease progression | Drug | 2 |
| BrivanibAlso: BMS-582664Tablets, Oral, 600 mg, once daily, until disease progression | Drug | 3 |
| BrivanibAlso: BMS-582664Tablets, Oral, 800 mg, once daily, until disease progression | Drug | 4 |
| BrivanibAlso: BMS-582664Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression | Drug | 5 |
| BrivanabAlso: BMS-582664Tablets, Oral, 1000 mg, once daily, until disease progression | Drug | 6 |
Primary outcome
Safety assessment
Time frame: throughout the study
dose-limiting toxicity (DLT)
Time frame: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified
determination of maximum tolerated dose (MTD)
Time frame: during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified
1 secondary outcome
Efficacy based on duration of response and time to progression based on assessment
Time frame: measured every 8 weeks throughout the 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 Nov 2008.
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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
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brivanib and Brivanab in people with Tumors and Neoplasm Metastasis, run by Bristol-Myers Squibb at 8 sites in 4 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 9 inclusion and 0 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 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada, United Kingdom, Italy. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety assessment (time frame: throughout the study). The study lists 3 primary outcomes in all. 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 4 Nov 2008.