Advanced Solid TumorsPhase 1NCT00792558
Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced Cancers
A Phase 1 study testing BMS-817378 in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 3 sites in 2 countries.
Trial summary
The purpose of this study is to find the maximum tolerated dose of BMS-817378 in subjects with advanced cancers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- BMS-817378
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2009to Nov 2010
- 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
- Confirmed diagnosis of advanced non-hematologic malignancy. Dose expansion cohort restricted to subjects with advanced or metastatic gastroesophageal cancer, squamous cell cancers of the head and neck, and castration resistant prostate cancer
- ECOG status 0-1
Who cannot join
- WOCBP unwilling/unable to use acceptable contraception methods, and women pregnant or breast feeding
- Symptomatic brain metastasis
- Uncontrolled or significant cardiovascular disease
- History of thromboembolic events or bleeding diathesis in past 6 months
- Conditions requiring prophylactic anticoagulation or chronic anti-platelet therapy
- Serious non-healing wounds, ulcers or bone fractures in past 3 months
Show all 10Show fewer
- Hemorrhage or bleeding event >= CTCAE grade 3 in past 4 weeks
- Proteinuria >= 2+ on dipstick or >= 1gm/24 hours
- Concurrent chemotherapy, hormonal therapy, immunotherapy, radiation therapy or therapy with any other investigational product
- Concurrent herbal, alternative, food supplements, or strong CYP 3A4 inhibitors or inducers
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Australia2 sites
Local Institution
Adelaide, South Australia, 5000
Local Institution
Nedlands, Western Australia, 6009
About this study
Official title: A Phase I Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced or Metastatic Solid Tumors
The purpose of this study is to find the maximum tolerated dose of BMS-817378 in subjects with advanced cancers
- Conditions
- Advanced Solid Tumors
- Being tested
- BMS-817378
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-817378Drug
Capsule, Oral, Dose escalation to a MTD from a starting dose of 25 mg, once daily, until disease progression/subject discontinuation
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: BMS-817378 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the MTD of BMS-817378 when administered orally on a daily schedule in subjects with advanced cancers
Measured: Within the first 21 days after first dose of BMS-817378
Secondary outcomes (5)
Assess safety and tolerability of multiple doses of BMS-817378 administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors
Measured: All time points while subject is on study
Assess the safety and tolerability of co-administration of a CYP substrate cocktail and BMS-817378 given at or below the MTD (dose expansion cohort)
Measured: Day 22 +/-2
Characterize the pharmacokinetics of BMS-817378 and its active moiety, BMS-794833
Measured: Days 1 and 15
Assess the effects of BMS-817378 and BMS-794833 on blood pressure, heart rate, ECG intervals, and left ventricular ejection fraction
Measured: All time points while subject is on study
Describe preliminary evidence for anti-tumor activity of BMS-817378
Measured: Every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionNov 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT00792558
- Sponsor's protocol ID
- CA195-001
- Status last verified
- Jan 2009
- First submitted
- 17 Nov 2008
- Last updated
- 1 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT00792558
- Acronym / sponsor ID
- CA195-001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 18 Nov 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 find the maximum tolerated dose of BMS-817378 in subjects with advanced cancers
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: BMS-817378 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of advanced non-hematologic malignancy. Dose expansion cohort restricted to subjects with advanced or metastatic gastroesophageal cancer, squamous cell cancers of the head and neck, and castration resistant prostate cancer
- ECOG status 0-1
Key exclusion criteria (10 listed)
- WOCBP unwilling/unable to use acceptable contraception methods, and women pregnant or breast feeding
- Symptomatic brain metastasis
- Uncontrolled or significant cardiovascular disease
- History of thromboembolic events or bleeding diathesis in past 6 months
- Conditions requiring prophylactic anticoagulation or chronic anti-platelet therapy
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-817378Capsule, Oral, Dose escalation to a MTD from a starting dose of 25 mg, once daily, until disease progression/subject discontinuation | Drug | Single Arm |
Primary outcome
To establish the MTD of BMS-817378 when administered orally on a daily schedule in subjects with advanced cancers
Time frame: Within the first 21 days after first dose of BMS-817378
5 secondary outcomes
Assess safety and tolerability of multiple doses of BMS-817378 administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors
Time frame: All time points while subject is on study
Assess the safety and tolerability of co-administration of a CYP substrate cocktail and BMS-817378 given at or below the MTD (dose expansion cohort)
Time frame: Day 22 +/-2
Characterize the pharmacokinetics of BMS-817378 and its active moiety, BMS-794833
Time frame: Days 1 and 15
Assess the effects of BMS-817378 and BMS-794833 on blood pressure, heart rate, ECG intervals, and left ventricular ejection fraction
Time frame: All time points while subject is on study
Describe preliminary evidence for anti-tumor activity of BMS-817378
Time frame: Every 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
Related trials for Advanced Solid Tumors
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-817378 in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 3 sites in 2 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 2 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: withdrawn, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Singapore. 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 was withdrawn before enrolling participants, so there are no results.
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 establish the MTD of BMS-817378 when administered orally on a daily schedule in subjects with advanced cancers (time frame: Within the first 21 days after first dose of BMS-817378). 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 1 Sep 2015.