CancerPhase 1NCT00329004
A Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study testing BMS-690514 in people with Cancer and Tumor, run by Bristol-Myers Squibb at 7 sites in 4 countries.
Trial summary
The purpose of this research study is to determine the highest dose of the drug (BMS-690514) that can be safely given to patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- BMS-690514
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Aug 2006to Jul 2009
- 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
- Men and women 18 and older
- Diagnosis of any solid tumor
- ECOG performance status score 0-1
- Prior chemo-therapy, immunotherapy or radiotherapy with at least 4 weeks since the last treatment
- Treatment with VEGFR2 or HER1 TKI allowed but not both (for instance Avastin or Tarceva, but not both)
Who cannot join
- Treatment with other TKIs within the past 4 weeks
- Patients with brain metastasis
- Patients with centrally located squamous cell carcinoma of the lung
- Major gastrointestinal surgery which may affect absorption of the drug
- Any surgery within last 4 weeks
- History of thromboembolism
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- Severe unmanageable diarrhea
- Subjects in Part B will have Non-Small Cell Lung Cancer (NSCLC)
- Part B/Cohort I erlotinib-naive subjects
- Part B/Cohort II subjects who have experienced disease progression while receiving erlotinib (erlotinib-resistant subjects)
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United States2 sites
The University Of Texas Md Anderson Cancer Center
Houston, Texas, 77030
Indiana University Med Center
Indianapolis, Indiana, 46202
Canada2 sites
Local Institution
Ottawa, Ontario, K1H 8L6
Local Institution
Toronto, Ontario, M5G 2M9
France2 sites
Local Institution
Toulouse, 31052
Local Institution
Villejuif, 94805
About this study
Official title: A Phase I Dose Escalation Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors
The purpose of this research study is to determine the highest dose of the drug (BMS-690514) that can be safely given to patients with advanced cancer.
- Being tested
- BMS-690514
- Keywords
- Solid Tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-690514Drug
Also called panHER
Tablets, Oral, up to 300 mg, once daily, up to 24 mos
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: BMS-690514 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks
Highest dose tolerated
Measured: continuous medical review of adverse event reports
Secondary outcomes (1)
Effective dose or doses of BMS-690514
Measured: tumor measurement by imaging every eight weeks. Continuous medical review of adverse event reports
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startAug 2006
- Primary completionJul 2009
- Study completionJul 2009
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 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 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
- NCT00329004
- Sponsor's protocol ID
- CA187-002
- Status last verified
- Aug 2009
- First submitted
- 19 May 2006
- Last updated
- 25 Jan 2011
- Results posted
- No
Publications
Soria JC, Baselga J, Hanna N, Laurie SA, Bahleda R, Felip E, Calvo E, Armand JP, Shepherd FA, Harbison CT, Berman D, Park JS, Zhang S, Vakkalagadda B, Kurland JF, Pathak AK, Herbst RS. Phase I-IIa study of BMS-690514, an EGFR, HER-2 and -4 and VEGFR-1 to -3 oral tyrosine kinase inhibitor, in patients with advanced or metastatic solid tumours. Eur J Cancer. 2013 May;49(8):1815-24. doi: 10.1016/j.ejca.2013.02.012. Epub 2013 Mar 13.
PubMed 23490650
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT00329004
- Acronym / sponsor ID
- CA187-002
- Keywords
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 24 May 2006 (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 research study is to determine the highest dose of the drug (BMS-690514) that can be safely given to patients with advanced cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BMS-690514 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women 18 and older
- Diagnosis of any solid tumor
- ECOG performance status score 0-1
- Prior chemo-therapy, immunotherapy or radiotherapy with at least 4 weeks since the last treatment
- Treatment with VEGFR2 or HER1 TKI allowed but not both (for instance Avastin or Tarceva, but not both)
Key exclusion criteria (10 listed)
- Treatment with other TKIs within the past 4 weeks
- Patients with brain metastasis
- Patients with centrally located squamous cell carcinoma of the lung
- Major gastrointestinal surgery which may affect absorption of the drug
- Any surgery within last 4 weeks
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 |
|---|---|---|
| BMS-690514Also: panHERTablets, Oral, up to 300 mg, once daily, up to 24 mos | Drug | 1 |
Primary outcome
Safety
Time frame: results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks
Highest dose tolerated
Time frame: continuous medical review of adverse event reports
1 secondary outcome
Effective dose or doses of BMS-690514
Time frame: tumor measurement by imaging every eight weeks. Continuous medical review of adverse event reports
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 25 Jan 2011.
- Derived from this study: PubMed 23490650Soria JC, Baselga J, Hanna N, Laurie SA, Bahleda R, Felip E, Calvo E, Armand JP, Shepherd FA, Harbison CT, Berman D, Park JS, Zhang S, Vakkalagadda B, Kurland JF, Pathak AK, Herbst RS. Phase I-IIa study of BMS-690514, an EGFR, HER-2 and -4 and VEGFR-1 to -3 oral tyrosine kinase inhibitor, in patients with advanced or metastatic solid tumours. Eur J Cancer. 2013 May;49(8):1815-24. doi: 10.1016/j.ejca.2013.02.012. Epub 2013 Mar 13.
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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
7 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 BMS-690514 in people with Cancer and Tumor, run by Bristol-Myers Squibb at 7 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 5 inclusion and 10 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 25 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada, France, Spain. 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 (time frame: results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks). The study lists 2 primary outcomes in all. 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 NCT00329004, 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 25 Jan 2011.