NeoplasmsPhase 1NCT00569036
Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Advanced or Metastatic Solid Tumors
A Phase 1 study testing BMS-754807 in people with Neoplasms and Solid Tumors, run by Bristol-Myers Squibb at 5 sites in Australia.
Trial summary
This is a Phase 1 dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 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
- Neoplasms, Solid Tumors, Metastases
- What is being tested?
- BMS-754807
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 5 sitesAustralia
- Study dates
- Apr 2008to Apr 2013
- 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
- Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
- ECOG performance status 0-1
- at least 4 weeks between surgery or last dose prior anti-cancer therapy
Who cannot join
- symptomatic brain metastases
- any disorder or dysregulation of glucose homeostasis {e.g. diabetes)
- uncontrolled or significant cardiovascular disease
- inadequate bone marrow, liver or kidney function
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Local Institution
East Melbourne, Victoria, 3002
Local Institution
Footscray, Victoria, 3011
Local Institution
Heidelberg, Victoria, 3084
Local Institution
Nedlands, Western Australia, 6009
Local Institution
Parkville, Victoria, 3050
About this study
Official title: A Phase I Multiple Ascending Dose Study of BMS-754807 in Subjects With Advanced or Metastatic Solid Tumors
This is a Phase 1 dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in patients with advanced or metastatic solid tumors. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 for Phase 2 studies
- Conditions
- Neoplasms, Solid Tumors, Metastases
- Being tested
- BMS-754807
- Keywords
- Advanced or Metastatic Solid Tumors or Neoplasms
- 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.
BMS-754807Drug
Also called IGF-IR
Tablets, Oral, Dose Cohorts: 4mg, 10mg, 20mg, 30mg, 50mg, 70mg, 100mg, 130mg, 160mg, 200mg, Once Daily, Until disease progression, unacceptable toxicity or at the subject's request
| Study group | Role | What they receive |
|---|---|---|
| BMS-754807 | Experimental | Single arm, multiple-ascending dose escalation study Receives: Drug: BMS-754807 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
Measured: Continuous assessment throughout the duration of the trial
Secondary outcomes (5)
Pharmacokinetics
Measured: assessed during the first 4 weeks of the study
Pharmacodynamics
Measured: assessed during the first 4 weeks of the study
Metabolic measures
Measured: assessed during the first 4 weeks of the study
ECG
Measured: assessed during the first 4 weeks of the study
Efficacy Measures
Measured: assessed every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startApr 2008
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- 63 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
- NCT00569036
- Sponsor's protocol ID
- CA191-002
- Status last verified
- Aug 2013
- First submitted
- 4 Dec 2007
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Multiple Ascending Dose Study of BMS-754807 in Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT00569036
- Acronym / sponsor ID
- CA191-002
- Conditions
- Neoplasms, Solid Tumors, Metastases
- Keywords
- Advanced or Metastatic Solid Tumors or Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 6 Dec 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 is a Phase 1 dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in patients with advanced or metastatic solid tumors. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 for Phase 2 studies
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-754807 | Experimental | Drug: BMS-754807Single arm, multiple-ascending dose escalation study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
- ECOG performance status 0-1
- at least 4 weeks between surgery or last dose prior anti-cancer therapy
Key exclusion criteria (4 listed)
- symptomatic brain metastases
- any disorder or dysregulation of glucose homeostasis {e.g. diabetes)
- uncontrolled or significant cardiovascular disease
- inadequate bone marrow, liver or kidney function
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-754807Also: IGF-IRTablets, Oral, Dose Cohorts: 4mg, 10mg, 20mg, 30mg, 50mg, 70mg, 100mg, 130mg, 160mg, 200mg, Once Daily, Until disease progression, unacceptable toxicity or at the subject's request | Drug | BMS-754807 |
Primary outcome
Safety - Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
Time frame: Continuous assessment throughout the duration of the trial
5 secondary outcomes
Pharmacokinetics
Time frame: assessed during the first 4 weeks of the study
Pharmacodynamics
Time frame: assessed during the first 4 weeks of the study
Metabolic measures
Time frame: assessed during the first 4 weeks of the study
ECG
Time frame: assessed during the first 4 weeks of the study
Efficacy Measures
Time frame: assessed every 8 weeks
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 14 Aug 2013.
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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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-754807 in people with Neoplasms and Solid Tumors, run by Bristol-Myers Squibb at 5 sites in Australia.
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 3 inclusion and 4 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 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. 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 - Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3 (time frame: Continuous assessment throughout the duration of the trial). 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 14 Aug 2013; AzTrials last refreshed its copy on 6 Nov 2026.