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Due to portfolio/business decisions by the sponsor
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Phase 1 (Cohort 6): BMS-911543 (120 mg) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-911543 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Day 1, at each returning on-treatment visit and the first post-treatment visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| The Mount Sinai School Of Medicine |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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98 participants were enrolled and 84 participants were treated. 14 participants did not enter treatment period (13 no longer met study criteria and 1 due to other reasons). 42 entered Phase 1 and 42 entered Phase 2
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| ID | Title | Description |
|---|---|---|
| FG000 | 5 mg Phase I | BMS-911543 5 mg capsule by mouth twice daily |
| FG001 | 10 mg Phase I | BMS-911543 10 mg capsule by mouth twice daily |
| FG002 | 20 mg Phase I | BMS-911543 20 mg capsule by mouth twice daily |
| FG003 | 40 mg Phase I | BMS-911543 40 mg capsule by mouth twice daily |
| FG004 | 80 mg Phase I | BMS-911543 80 mg capsule by mouth twice daily |
| FG005 | 120 mg Phase I | BMS-911543 120 mg capsule by mouth twice daily |
| FG006 | 160 mg Phase I | BMS-911543 160 mg capsule by mouth twice daily |
| FG007 | 200 mg Phase I | BMS-911543 2000 mg capsule by mouth twice daily |
| FG008 | 240 mg Phase I | BMS-911543 240 mg capsule by mouth twice daily |
| FG009 | 120 mg Phase II | BMS-911543 120 mg capsule by mouth twice daily |
| FG010 | 200 mg Phase II | BMS-911543 200 mg capsule by mouth twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All treated participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 5 mg Phase I | BMS-911543 5 mg capsule by mouth twice daily |
| BG001 | 10 mg Phase I | BMS-911543 10 mg capsule by mouth twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All treated participants | Posted | Count of Participants | Participants | 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 |
|
From the date of subject's written consent until 30 days post discontinuation of dosing or subject's participation in the study if the last scheduled visit occurs at a later time (approximately 4.5 years)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5 mg Phase I | BMS-911543 5 mg capsule by mouth twice daily | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version: 18.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D046248 | Pyloric Stenosis, Hypertrophic |
| ID | Term |
|---|---|
| D011707 | Pyloric Stenosis |
| D017219 | Gastric Outlet Obstruction |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571029 | N,N-dicyclopropyl-4-((1,5-dimethyl-1H-pyrazol-3-yl)amino)-6-ethyl-1-methyl-1,6-dihydroimidazo(4,5-d)pyrrolo(2,3b)pyridine-7-carboxamide |
Not provided
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| Experimental |
BMS-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 | BMS-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 | BMS-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 | BMS-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 | BMS-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 | BMS-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 | BMS-911543 200 mg capsule by mouth twice daily for 12 months or greater depending on response |
|
|
| 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study |
| New York |
| New York |
| 10029 |
| United States |
| The University Of Texas Md Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Local Institution | East Melbourne | Victoria | 3002 | Australia |
| Local Institution | Melbourne | Victoria | 3050 | Australia |
| Withdrawal by Subject |
|
| Adverse Event |
|
| Study drug toxicity |
|
| Disease progression |
|
| Poor/Non-compliance |
|
| Maximum clinical benefit |
|
| Subject request to discontinue treatment |
|
| Subject to receive drug via EAP |
|
| Patient moving to allogeneic transplant |
|
| Relapse of Splenomegaly and symptoms |
|
| Lack of response to drug |
|
| Patient transferred to IST |
|
| BG002 | 20 mg Phase I | BMS-911543 20 mg capsule by mouth twice daily |
| BG003 | 40 mg Phase I | BMS-911543 40 mg capsule by mouth twice daily |
| BG004 | 80 mg Phase I | BMS-911543 80 mg capsule by mouth twice daily |
| BG005 | 120 mg Phase I | BMS-911543 120 mg capsule by mouth twice daily |
| BG006 | 160 mg Phase I | BMS-911543 160 mg capsule by mouth twice daily |
| BG007 | 200 mg Phase I | BMS-911543 2000 mg capsule by mouth twice daily |
| BG008 | 240 mg Phase I | BMS-911543 240 mg capsule by mouth twice daily |
| BG009 | 120 mg Phase II | BMS-911543 120 mg capsule by mouth twice daily |
| BG010 | 200 mg Phase II | BMS-911543 200 mg capsule by mouth twice daily |
| BG011 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
BMS-911543 10 mg capsule by mouth twice daily |
| OG002 | 20 mg Phase I | BMS-911543 20 mg capsule by mouth twice daily |
| OG003 | 40 mg Phase I | BMS-911543 40 mg capsule by mouth twice daily |
| OG004 | 80 mg Phase I | BMS-911543 80 mg capsule by mouth twice daily |
| OG005 | 120 mg Phase I | BMS-911543 120 mg capsule by mouth twice daily |
| OG006 | 160 mg Phase I | BMS-911543 160 mg capsule by mouth twice daily |
| OG007 | 200 mg Phase I | BMS-911543 2000 mg capsule by mouth twice daily |
| OG008 | 240 mg Phase I | BMS-911543 240 mg capsule by mouth twice daily |
| OG009 | 120 mg Phase II | BMS-911543 120 mg capsule by mouth twice daily |
| OG010 | 200 mg Phase II | BMS-911543 200 mg capsule by mouth twice daily |
|
|
| Primary | 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. | All treated participants | Posted | Count of Participants | Participants | Day 1, at each returning on-treatment visit and the first post-treatment visit |
|
|
|
| Secondary | 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. | Data for this outcome measure was not collected for any participants because the study was terminated | Posted | Up to 6 months |
|
|
| Secondary | 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 | Data for this outcome measure was not collected for any participants because the study was terminated | Posted | Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study |
|
|
| Secondary | 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) | Data for this outcome measure was not collected for any participants because the study was terminated | Posted | Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study |
|
|
| Secondary | 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 | Data for this outcome measure was not collected for any participants because the study was terminated | Posted | Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study |
|
|
| Secondary | 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 | Data for this outcome measure was not collected for any participants because the study was terminated | Posted | Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study |
|
|
| Secondary | 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 | Data for this outcome measure was not collected for any participants because the study was terminated | Posted | Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study |
|
|
| Secondary | 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 | Data for this outcome measure was not collected for any participants because the study was terminated | Posted | Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study |
|
|
| Secondary | 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 | Data for this outcome measure was not collected for any participants because the study was terminated | Posted | Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study |
|
|
| Secondary | 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 | Data for this outcome measure was not collected for any participants because the study was terminated | Posted | Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study |
|
|
| Secondary | 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 | Data for this outcome measure was not collected for any participants because the study was terminated | Posted | Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study |
|
|
| Secondary | 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 | Data for this outcome measure was not collected for any participants because the study was terminated | Posted | Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study |
|
|
| Secondary | 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 | Data for this outcome measure was not collected for any participants because the study was terminated | Posted | Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study |
|
|
| 4 |
| 3 |
| 4 |
| 4 |
| 4 |
| EG001 | 10 mg Phase I | BMS-911543 10 mg capsule by mouth twice daily | 0 | 4 | 2 | 4 | 4 | 4 |
| EG002 | 20 mg Phase I | BMS-911543 20 mg capsule by mouth twice daily | 0 | 4 | 2 | 4 | 4 | 4 |
| EG003 | 40 mg Phase I | BMS-911543 40 mg capsule by mouth twice daily | 0 | 4 | 1 | 4 | 4 | 4 |
| EG004 | 80 mg Phase I | BMS-911543 80 mg capsule by mouth twice daily | 1 | 4 | 4 | 4 | 4 | 4 |
| EG005 | 120 mg Phase I | BMS-911543 120 mg capsule by mouth twice daily | 1 | 4 | 2 | 4 | 4 | 4 |
| EG006 | 160 mg Phase I | BMS-911543 160 mg capsule by mouth twice daily | 1 | 8 | 6 | 8 | 8 | 8 |
| EG007 | 200 mg Phase I | BMS-911543 2000 mg capsule by mouth twice daily | 2 | 7 | 2 | 7 | 7 | 7 |
| EG008 | 240 mg Phase I | BMS-911543 240 mg capsule by mouth twice daily | 0 | 3 | 1 | 3 | 3 | 3 |
| EG009 | 120 mg Phase II | BMS-911543 120 mg capsule by mouth twice daily | 1 | 22 | 9 | 22 | 22 | 22 |
| EG010 | 200 mg Phase II | BMS-911543 200 mg capsule by mouth twice daily | 0 | 20 | 10 | 20 | 20 | 20 |
| Lung infection | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Atypical mycobacterial lymphadenitis | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Gastroentiritis | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Listeriosis | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Spleen disorder | Blood and lymphatic system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Splenic infarction | Blood and lymphatic system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Supraventricular Tachycardia | Cardiac disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version: 18.1 | Systematic Assessment |
|
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version: 18.1 | Systematic Assessment |
|
| Adenosquamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version: 18.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version: 18.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version: 18.1 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA Version: 18.1 | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA Version: 18.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Version: 18.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA Version: 18.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA Version: 18.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Blood pressure inadequately controlled | Vascular disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Capillary leak syndrome | Vascular disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Spleen disorder | Blood and lymphatic system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Early satiety | General disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA Version: 18.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Version: 18.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Version: 18.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA Version: 18.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| D004066 |
| Digestive System Diseases |
| Partial Remission |
|
| Clinical Improvement |
|
| Stable Disease |
|
| Progressive Disease |
|
| Relapse |
|