NeoplasmsPhase 1NCT00898716
Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan
A Phase 1 study testing BMS-754807 in people with Neoplasms, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
The purpose of this clinical study is to establish the maximum tolerated dose of BMS-754807 when administered orally on a once daily schedule in subjects with solid tumors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neoplasms
- 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
- 15 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2009to Jul 2011
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group performance 0-1
Who cannot join
- Any disorder with dysregulation of glucose homeostasis
- Dumping syndrome
- History of glucose intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan
The purpose of this clinical study is to establish the maximum tolerated dose of BMS-754807 when administered orally on a once daily schedule in subjects with solid tumors.
- Conditions
- Neoplasms
- Being tested
- BMS-754807
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-754807Drug
Tablets, Oral, 20 mg, 30 mg, 50 mg, 70 mg, 100 mg, 130 mg, 160 mg, 200 mg once daily, 3-5 months, depending on response
| Study group | Role | What they receive |
|---|---|---|
| BMS-754807 | Experimental | Not described Receives: Drug: BMS-754807 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the Maximum Tolerated Dose of BMS-754807 based on the Dose Limited Toxicity which observed during the first 28 days
Measured: Within the first 28 days
Secondary outcomes (6)
To assess the safety and tolerability
Measured: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To establish recommended Phase 2 dose of BMS-754807 when administered orally on a once daily schedule
Measured: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To assess the metabolic effect on blood glucose
Measured: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To assess the pharmacokinetics of BMS-754807 administered orally on a once daily schedule
Measured: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To assess any preliminary evidence of anti-tumor activity
Measured: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To explore potential biomarkers of biological response
Measured: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2011
- Study completionJul 2011
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT00898716
- Sponsor's protocol ID
- CA191-003
- Status last verified
- Jul 2010
- First submitted
- 11 May 2009
- Last updated
- 30 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan
- ClinicalTrials.gov ID
- NCT00898716
- Acronym / sponsor ID
- CA191-003
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 12 May 2009 (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 clinical study is to establish the maximum tolerated dose of BMS-754807 when administered orally on a once daily schedule in subjects with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-754807 | Experimental | Drug: BMS-754807 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group performance 0-1
Key exclusion criteria (3 listed)
- Any disorder with dysregulation of glucose homeostasis
- Dumping syndrome
- History of glucose intolerance
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-754807Tablets, Oral, 20 mg, 30 mg, 50 mg, 70 mg, 100 mg, 130 mg, 160 mg, 200 mg once daily, 3-5 months, depending on response | Drug | BMS-754807 |
Primary outcome
To determine the Maximum Tolerated Dose of BMS-754807 based on the Dose Limited Toxicity which observed during the first 28 days
Time frame: Within the first 28 days
6 secondary outcomes
To assess the safety and tolerability
Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To establish recommended Phase 2 dose of BMS-754807 when administered orally on a once daily schedule
Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To assess the metabolic effect on blood glucose
Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To assess the pharmacokinetics of BMS-754807 administered orally on a once daily schedule
Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To assess any preliminary evidence of anti-tumor activity
Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To explore potential biomarkers of biological response
Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 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 30 Nov 2011.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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
1 site 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, run by Bristol-Myers Squibb at 1 site in Japan.
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 3 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 30 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
To determine the Maximum Tolerated Dose of BMS-754807 based on the Dose Limited Toxicity which observed during the first 28 days (time frame: Within the first 28 days). 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 30 Nov 2011.