CancerPhase 1/2NCT01236352
Multiple Ascending Dose of BMS-911543
A Phase 1/2 study testing BMS-911543 in people with Cancer, run by Bristol-Myers Squibb at 5 sites in 2 countries.
Trial summary
The purpose of this first in human study is to determine if BMS-911543 is safe and tolerable in subjects with symptomatic intermediate-1, intermediate-2 or high risk myelofibrosis to permit clinical testing at the Maximum Tolerated Dose or at a Clinically Active Dose, and to determine if BMS-911543 will demonstrate… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- BMS-911543
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 7 Apr 2011to 19 Nov 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men and Women at least 18 years old
- A diagnosis of symptomatic, primary or secondary Myelofibrosis (MF) [World Health Organization (WHO) 2008 criteria] with intermediate-1, intermediate-2 or high risk disease as assessed using the Dynamic International Prognostic Scoring System international prognostic scoring system
- Last therapeutic or diagnostic treatment at least 28 days prior
- Any toxicity from prior therapies must have resolved to Grade ≤1
- Adequate Liver and Kidney Function
- Serum amylase and lipase within normal institutional range
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- Platelet count ≥50,000 cell mm³
- Absolute neutrophil count (ANC) ≥1,000 cells/mm3
- Hemoglobin ≥8.0 g/dL
Who cannot join
- Primary central nervous system tumors
- Subjects with currently active malignancy (other than MF) or with a prior history of malignancy with the exception of: (i) adequately treated basal cell carcinoma of the skin, (ii) curatively treated in situ carcinoma of the cervix, (iii) other malignancy that has undergone potentially curative therapy with no evidence of disease recurrence ≥3 years
- Any condition requiring chronic use of moderate/high dose steroids except inhalation or oral steroids for mild pulmonary disease
- Splenic irradiation ≤3 months prior to treatment with study drug
- Positive blood screen for hepatitis C antibody, hepatitis B surface antigen or Human Immunodeficiency Virus-1 (HIV-1), or HIV-2 antibodies
- Abnormalities in serum electrolytes
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- Significant cardiovascular disease
- Current or recent gastrointestinal disease
- Previous history of pancreatitis and/or significant risk factors for pancreatitis as judged by the treating physician
- Evidence of uncontrolled active infection or active graft vs. host disease
- Inability to tolerate oral medication
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
The University Of Texas Md Anderson Cancer Center
Houston, Texas, 77030
The Mount Sinai School Of Medicine
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55905
Australia2 sites
Local Institution
East Melbourne, Victoria, 3002
Local Institution
Melbourne, Victoria, 3050
About this study
Official title: A Phase 1/2 Multiple Ascending Dose Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BMS-911543 in Subjects With Myelofibrosis
The purpose of this first in human study is to determine if BMS-911543 is safe and tolerable in subjects with symptomatic intermediate-1, intermediate-2 or high risk myelofibrosis to permit clinical testing at the Maximum Tolerated Dose or at a Clinically Active Dose, and to determine if BMS-911543 will demonstrate efficacy in symptomatic myelofibrosis.
- Conditions
- Cancer
- Being tested
- BMS-911543
- Keywords
- Advanced Cancer, Various, NOS
- Medical subject headings
- Neoplasms, Pyloric Stenosis, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-911543Drug
Also called JAK2 Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 (Cohort 1): BMS-911543 (5 mg) | Experimental | BMS-911543 5 mg capsule by mouth twice daily for 12 months or greater depending on response Receives: Drug: BMS-911543 |
| Phase 1 (Cohort 2): BMS-911543 (10 mg) | Experimental | BMS-911543 10 mg capsule by mouth twice daily for 12 months or greater depending on response Receives: Drug: BMS-911543 |
| Phase 1 (Cohort 3): BMS-911543 (20 mg) | Experimental | BMS-911543 20 mg capsule by mouth twice daily for 12 months or greater depending on response Receives: Drug: BMS-911543 |
| Phase 1 (Cohort 4): BMS-911543 (40 mg) | Experimental | BMS-911543 40 mg capsule by mouth twice daily for 12 months or greater depending on response Receives: Drug: BMS-911543 |
| Phase 1 (Cohort 5): BMS-911543 (80 mg) | Experimental | BMS-911543 80 mg capsule by mouth twice daily for 12 months or greater depending on response Receives: Drug: BMS-911543 |
| Phase 1 (Cohort 6): BMS-911543 (120 mg) | Experimental | BMS-911543 120 mg capsule by mouth twice daily for 12 months or greater depending on response Receives: Drug: BMS-911543 |
| Phase 1 (Cohort 7): BMS-911543 (160 mg) | Experimental | BMS-911543 160 mg capsule by mouth twice daily for 12 months or greater depending on response Receives: Drug: BMS-911543 |
| Phase 1 (Cohort 8): BMS-911543 (200 mg) | Experimental | BMS-911543 200 mg capsule by mouth twice daily for 12 months or greater depending on response Receives: Drug: BMS-911543 |
| Phase 1 (Cohort 9): BMS-911543 (240 mg) | Experimental | BMS-911543 240 mg capsule by mouth twice daily for 12 months or greater depending on response Receives: Drug: BMS-911543 |
| Phase 1 (Cohort 10): BMS-911543 (320 mg) | Experimental | BMS-911543 320 mg capsule by mouth twice daily for 12 months or greater depending on response Receives: Drug: BMS-911543 |
| Phase 2 (Cohort 11): BMS-911543 (120 mg) | Experimental | BMS-911543 120 mg capsule by mouth twice daily for 12 months or greater depending on response Receives: Drug: BMS-911543 |
| Phase 2 (Cohort 12): BMS-911543 (200 mg) | Experimental | BMS-911543 200 mg capsule by mouth twice daily for 12 months or greater depending on response Receives: Drug: BMS-911543 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Safety assessments were based on a medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests and were evaluated for all treated participants using National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (NCI CTCAE v.4.0).
Measured: From the date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occured at a later time, assessed up to 4.5 years
Number of Participants With Best Overall Response
Participants were clinically assessed for IWG-(International Working Group consensus criteria for treatment response in myelofibrosis with myeloid metaplasia) defined response at each returning on-treatment visit and the first post-treatment visit. IWG-MRT criteria for best overall response are ordered high to low: CR>PR>CI>SD>PD>R where CR = Complete Remission, PR= Partial Remission, CI = Clinical Improvement, SD = Stable Disease, PD = Progressive Disease and R = Relapse. Best overall response is the best response of the subject during the treatment period or at the first post-treatment visit.
Measured: Day 1, at each returning on-treatment visit and the first post-treatment visit
Secondary outcomes (12)
Changes in (Janus Kinase) JAK/Signal Transducers and Activators of Transcription (STATs) Pathway Activities, Circulating CD34+ Cells and Plasma Cytokine Levels
JAK/STAT pathway activity will be evaluated by: 1) pSTATs levels using immunoassay; 2) expression levels of several JAK/STATs pathway genes. Whole blood will be collected at specific time-points. Due to portfolio/business decisions by the sponsor, the compound is no longer being developed and the study was terminated. Analysis was not completed because the study was terminated. This decision was not based on any safety concerns associated with BMS-911543.
Measured: Up to 6 months
Maximum Observed Plasma Concentration (Cmax) of BMS-911543 and it's Metabolite BMS-926796 (Met4)
Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: Cmax Maximum observed plasma concentration
Measured: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Trough Observed (Pre-dose) Plasma Concentration (Cmin) of BMS-911543 and it's Metabolite Met4
Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: Cmin (Trough observed (pre-dose) plasma concentration)
Measured: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-911543 and it's Metabolite Met4
Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: Tmax = Time of maximum observed plasma concentration (Tmax) of BMS-911543 and it's metabolite Met4
Measured: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (for Single Dose Period Only) (AUC(INF)) of BMS-911543 and it's Metabolite Met4
Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: AUC(INF) = Area under the plasma concentration-time curve from time zero extrapolated to infinite time (for single dose period only) (AUC(INF)) of BMS-911543 and it's metabolite Met4
Measured: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration (for Single Dose Period Only) (AUC(0-T)) of BMS-911543 and it's Metabolite Met4
Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: AUC (0-T) = Area under the plasma concentration-time curve from time zero to the time of last quantifiable plasma concentration (for single dose period only) of BMS-911543 and it's metabolite Met4
Measured: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU)) of BMS-911543 and it's Metabolite Met4
Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: AUC (TAU) = Area under the concentration-time curve in one dosing interval of BMS-911543 and it's metabolite Met4
Measured: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
The Terminal-phase Elimination Half-life in Plasma (T-HALF) of BMS-911543 and it's Metabolite Met4
Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: T-HALF = The terminal-phase elimination half-life in plasma of BMS-911543 and it's metabolite Met4
Measured: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Apparent Total Clearance (for Parent Compound Only) (CLT/F) of BMS-911543 and it's Metabolite Met4
Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: CLT/F = Apparent total clearance (for parent compound only) of BMS-911543 and it's metabolite Met4
Measured: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Apparent Volume of Distribution After First Dosing Based on the Terminal Phase (for Parent Compound Only) (Vz/F) of BMS-911543 and it's Metabolite Met4
Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: Vz/F = Apparent volume of distribution after first dosing based on the terminal phase (for parent compound only) of BMS-911543 and it's metabolite Met4
Measured: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Accumulation Index (AI): Ratio of AUC(TAU) on Day 15 to AUC(TAU) After the First Dose of BMS-911543 and it's Metabolite Met4
Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: Accumulation index (AI) = ratio of AUC(TAU) on Day 15 to AUC(TAU) after the first dose of BMS-911543 and it's metabolite Met4
Measured: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Ratio of BMS-926796 AUC(INF) to BMS-911543 AUC(INF) After 1st Dose and BMS-926796 AUC(TAU) to BMS-911543 AUC(TAU) on Day 15 (AUC Ratio)
Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: AUC Ratio = Ratio of BMS-926796 AUC(INF) to BMS-911543 AUC(INF) after 1st dose and BMS-926796 AUC(TAU) to BMS-911543 AUC(TAU) on Day 15
Measured: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study start7 Apr 2011
- Primary completion19 Nov 2015
- Study completion19 Nov 2015
Why it stopped: Due to portfolio/business decisions by the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 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
- NCT01236352
- Sponsor's protocol ID
- CA215-001
- Status last verified
- Jul 2019
- First submitted
- 5 Nov 2010
- Last updated
- 31 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Multiple Ascending Dose Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BMS-911543 in Subjects With Myelofibrosis
- ClinicalTrials.gov ID
- NCT01236352
- Acronym / sponsor ID
- CA215-001
- Conditions
- Cancer
- Keywords
- Advanced Cancer, Various, NOS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to portfolio/business decisions by the sponsor
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2011 (actual)
- Primary completion
- 19 Nov 2015 (actual)
- Study completion
- 19 Nov 2015 (actual)
- First posted
- 8 Nov 2010 (estimated)
- Results
- Posted 21 May 2019
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 first in human study is to determine if BMS-911543 is safe and tolerable in subjects with symptomatic intermediate-1, intermediate-2 or high risk myelofibrosis to permit clinical testing at the Maximum Tolerated Dose or at a Clinically Active Dose, and to determine if BMS-911543 will demonstrate efficacy in symptomatic myelofibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Phase 1 (Cohort 1): BMS-911543 (5 mg) | Experimental | Drug: BMS-911543BMS-911543 5 mg capsule by mouth twice daily for 12 months or greater depending on response |
| Phase 1 (Cohort 2): BMS-911543 (10 mg) | Experimental | Drug: BMS-911543BMS-911543 10 mg capsule by mouth twice daily for 12 months or greater depending on response |
| Phase 1 (Cohort 3): BMS-911543 (20 mg) | Experimental | Drug: BMS-911543BMS-911543 20 mg capsule by mouth twice daily for 12 months or greater depending on response |
| Phase 1 (Cohort 4): BMS-911543 (40 mg) | Experimental | Drug: BMS-911543BMS-911543 40 mg capsule by mouth twice daily for 12 months or greater depending on response |
| Phase 1 (Cohort 5): BMS-911543 (80 mg) | Experimental | Drug: BMS-911543BMS-911543 80 mg capsule by mouth twice daily for 12 months or greater depending on response |
| Phase 1 (Cohort 6): BMS-911543 (120 mg) | Experimental | Drug: BMS-911543BMS-911543 120 mg capsule by mouth twice daily for 12 months or greater depending on response |
| Phase 1 (Cohort 7): BMS-911543 (160 mg) | Experimental | Drug: BMS-911543BMS-911543 160 mg capsule by mouth twice daily for 12 months or greater depending on response |
| Phase 1 (Cohort 8): BMS-911543 (200 mg) | Experimental | Drug: BMS-911543BMS-911543 200 mg capsule by mouth twice daily for 12 months or greater depending on response |
| Phase 1 (Cohort 9): BMS-911543 (240 mg) | Experimental | Drug: BMS-911543BMS-911543 240 mg capsule by mouth twice daily for 12 months or greater depending on response |
| Phase 1 (Cohort 10): BMS-911543 (320 mg) | Experimental | Drug: BMS-911543BMS-911543 320 mg capsule by mouth twice daily for 12 months or greater depending on response |
| Phase 2 (Cohort 11): BMS-911543 (120 mg) | Experimental | Drug: BMS-911543BMS-911543 120 mg capsule by mouth twice daily for 12 months or greater depending on response |
| Phase 2 (Cohort 12): BMS-911543 (200 mg) | Experimental | Drug: BMS-911543BMS-911543 200 mg capsule by mouth twice daily for 12 months or greater depending on response |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Men and Women at least 18 years old
- A diagnosis of symptomatic, primary or secondary Myelofibrosis (MF) [World Health Organization (WHO) 2008 criteria] with intermediate-1, intermediate-2 or high risk disease as assessed using the Dynamic International Prognostic Scoring System international prognostic scoring system
- Last therapeutic or diagnostic treatment at least 28 days prior
- Any toxicity from prior therapies must have resolved to Grade ≤1
- Adequate Liver and Kidney Function
Key exclusion criteria (11 listed)
- Primary central nervous system tumors
- Subjects with currently active malignancy (other than MF) or with a prior history of malignancy with the exception of: (i) adequately treated basal cell carcinoma of the skin, (ii) curatively treated in situ carcinoma of the cervix, (iii) other malignancy that has undergone potentially curative therapy with no evidence of disease recurrence ≥3 years
- Any condition requiring chronic use of moderate/high dose steroids except inhalation or oral steroids for mild pulmonary disease
- Splenic irradiation ≤3 months prior to treatment with study drug
- Positive blood screen for hepatitis C antibody, hepatitis B surface antigen or Human Immunodeficiency Virus-1 (HIV-1), or HIV-2 antibodies
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-911543Also: JAK2 Inhibitor | Drug | Phase 1 (Cohort 1): BMS-911543 (5 mg), Phase 1 (Cohort 10): BMS-911543 (320 mg), Phase 1 (Cohort 2): BMS-911543 (10 mg), Phase 1 (Cohort 3): BMS-911543 (20 mg), Phase 1 (Cohort 4): BMS-911543 (40 mg), Phase 1 (Cohort 5): BMS-911543 (80 mg), Phase 1 (Cohort 6): BMS-911543 (120 mg), Phase 1 (Cohort 7): BMS-911543 (160 mg), Phase 1 (Cohort 8): BMS-911543 (200 mg), Phase 1 (Cohort 9): BMS-911543 (240 mg), Phase 2 (Cohort 11): BMS-911543 (120 mg), Phase 2 (Cohort 12): BMS-911543 (200 mg) |
Primary outcome
Number of Participants With Adverse Events
Time frame: From the date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occured at a later time, assessed up to 4.5 years
Safety assessments were based on a medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests and were evaluated for all treated participants using National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (NCI CTCAE v.4.0).
Number of Participants With Best Overall Response
Time frame: Day 1, at each returning on-treatment visit and the first post-treatment visit
Participants were clinically assessed for IWG-(International Working Group consensus criteria for treatment response in myelofibrosis with myeloid metaplasia) defined response at each returning on-treatment visit and the first post-treatment visit. IWG-MRT criteria for best overall response are ordered high to low: CR>PR>CI>SD>PD>R where CR = Complete Remission, PR= Partial Remission, CI = Clinical Improvement, SD = Stable Disease, PD = Progressive Disease and R = Relapse. Best overall response is the best response of the subject during the treatment period or at the first post-treatment visit.
12 secondary outcomes
Changes in (Janus Kinase) JAK/Signal Transducers and Activators of Transcription (STATs) Pathway Activities, Circulating CD34+ Cells and Plasma Cytokine Levels
Time frame: Up to 6 months
Maximum Observed Plasma Concentration (Cmax) of BMS-911543 and it's Metabolite BMS-926796 (Met4)
Time frame: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Trough Observed (Pre-dose) Plasma Concentration (Cmin) of BMS-911543 and it's Metabolite Met4
Time frame: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-911543 and it's Metabolite Met4
Time frame: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (for Single Dose Period Only) (AUC(INF)) of BMS-911543 and it's Metabolite Met4
Time frame: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration (for Single Dose Period Only) (AUC(0-T)) of BMS-911543 and it's Metabolite Met4
Time frame: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU)) of BMS-911543 and it's Metabolite Met4
Time frame: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
The Terminal-phase Elimination Half-life in Plasma (T-HALF) of BMS-911543 and it's Metabolite Met4
Time frame: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Apparent Total Clearance (for Parent Compound Only) (CLT/F) of BMS-911543 and it's Metabolite Met4
Time frame: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Apparent Volume of Distribution After First Dosing Based on the Terminal Phase (for Parent Compound Only) (Vz/F) of BMS-911543 and it's Metabolite Met4
Time frame: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Accumulation Index (AI): Ratio of AUC(TAU) on Day 15 to AUC(TAU) After the First Dose of BMS-911543 and it's Metabolite Met4
Time frame: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Ratio of BMS-926796 AUC(INF) to BMS-911543 AUC(INF) After 1st Dose and BMS-926796 AUC(TAU) to BMS-911543 AUC(TAU) on Day 15 (AUC Ratio)
Time frame: Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-911543 in people with Cancer, run by Bristol-Myers Squibb at 5 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 9 inclusion and 11 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: stopped early, as of the sponsor's last update on 31 Jul 2019. 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 United States, 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events (time frame: From the date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occured at a later time, assessed up to 4.5 years). 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?
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 31 Jul 2019.