A Study to Evaluate MK-0482 for Relapsed/Refractory Acute... | NCT05038800 | Trialant
NCT05038800
Sponsor
Merck Sharp & Dohme LLC
Status
Terminated
Last Update Posted
May 21, 2025Actual
Enrollment
13Actual
Phase
Phase 1
Conditions
Relapsed or Refractory Acute Myeloid Leukemia
Relapsed or Refractory Chronic Myelomonocytic Leukemia
Interventions
MK-0482
Countries
United States
Israel
Spain
Protocol Section
Identification Module
NCT ID
NCT05038800
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
0482-002
Secondary IDs
ID
Type
Description
Link
MK-0482-002
Other Identifier
MSD
2023-003740-27-00
Registry Identifier
EU CT
U1111-1287-5269
Registry Identifier
UTN
2022-003740-27
EudraCT Number
Brief Title
A Study to Evaluate MK-0482 for Relapsed/Refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML) (MK-0482-002)
Official Title
A Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of MK-0482 in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Business Reasons
Expanded Access Info
No
Start Date
Sep 26, 2021Actual
Primary Completion Date
Dec 11, 2023Actual
Completion Date
Dec 11, 2023Actual
First Submitted Date
Aug 24, 2021
First Submission Date that Met QC Criteria
Sep 7, 2021
First Posted Date
Sep 9, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Nov 4, 2024
Results First Submitted that Met QC Criteria
Nov 4, 2024
Results First Posted Date
Dec 11, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 19, 2025
Last Update Posted Date
May 21, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and recommended Phase 2 dose (RP2D) of MK-0482. There are 2 parts of this study. Part 1 is a dose escalation which will follow an accelerated titration design (ATD) for participants with relapsed/refractory (R/R) AML or CMML. Part 2 is a dose expansion for participants with R/R AML.
Detailed Description
In Part 1, single participants will be enrolled sequentially into escalating dose levels. Progression from one dose level to the next higher dose level will be based on the evaluation of dose-limiting toxicity (DLT). Once a preliminary RP2D is identified in Part 1, approximately 10 to 15 additional participants with R/R AML will be enrolled at the RP2D for Part 2.
Conditions Module
Conditions
Relapsed or Refractory Acute Myeloid Leukemia
Relapsed or Refractory Chronic Myelomonocytic Leukemia
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
13Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MK-0482 7.5 mg Q3W
Experimental
Participants will receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for up to 35 cycles (approximately 24 months).
Biological: MK-0482
MK-0482 25 mg Q3W
Experimental
Participants will receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Biological: MK-0482
MK-0482 75 mg Q3W
Experimental
Participants will receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Biological: MK-0482
MK-0482 225 mg Q3W
Experimental
Participants will receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Biological: MK-0482
MK-0482 750 mg Q3W
Experimental
Participants will receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MK-0482
Biological
IV infusion
MK-0482 225 mg Q3W
MK-0482 25 mg Q3W
MK-0482 7.5 mg Q3W
MK-0482 75 mg Q3W
MK-0482 750 mg Q3W
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Experienced a Dose-Limiting Toxicity (DLT)
DLTs were defined as any of the following assessed as treatment-related by investigator (with pre-specified exceptions): Grade (Gr) 4 non-hematologic toxicity; Gr 3 non-hematologic toxicity; Gr 3 or Gr 4 non-hematologic laboratory value if: clinically significant medical intervention was required to treat the participant, the abnormality led to hospitalization, the abnormality persisted for >1 week, electrolyte imbalances that lasted >48 hours despite optimal therapy, or the abnormality resulted in a drug-induced liver injury; Gr 4 neutropenia and/or thrombocytopenia lasting >14 days; >2 week-delay in starting Cycle 2 due to treatment-related toxicity; treatment-related toxicity resulting in treatment discontinuation during DLT evaluation period; missing >25% of MK-0482 dose during DLT evaluation period resulting from treatment-related adverse event (AE); or Gr 5 toxicity. The percentage of participants that experienced a DLT was reported for each arm.
Cycle 1 (up to 21 days)
Number of Participants Who Experience at Least One Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced at least one AE was reported for each arm.
Up to approximately 10 months
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE was reported for each arm.
Up to approximately 4 months
Secondary Outcomes
Measure
Description
Time Frame
Maximum Concentration (Cmax) of MK-0482
Cmax was defined as the maximum concentration of MK-0482 observed in plasma. Blood samples were collected pre-dose and post-dose at designated timepoints to determine Cmax of MK-0482.
Cycle 1: Pre-dose and Days 1, 2, 4, 8, and 15 post-dose. Cycle=21 days.
Minimum Concentration (Cmin) of MK-0482
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
-Has confirmed diagnosis of AML with myelomonocytic or monoblastic/monocytic differentiation per World Health Organization (WHO) 2016 criteria and with confirmed refractory or relapsed disease (i.e., ≥5% blast in bone marrow or in peripheral blood) after treatment with available therapies known to benefit participant's AML subtypes or has a known diagnosis of CMML per WHO criteria [2017] with confirmed refractory or released disease after treatment with available therapies known to be active for CMML.
Exclusion Criteria:
Has active central nervous system (CNS) leukemia.
Has isolated extramedullary disease, i.e., no leukemic involvement in bone marrow or peripheral blood.
Has diagnosis of acute promyelocytic leukemia or participants with known Philadelphia chromosome positive (Ph+) AML.
Has received previous allogeneic stem cell transplant or organ transplant within 60 days of the start of study treatment.
Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 1 year.
Has a history of any of the following cardiovascular conditions within 6 months of screening: myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, coronary artery bypass graft, or pulmonary embolism; has New York Heart Association (NYHA) Class III or IV congestive heart failure.
Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAB) and or any components of the study intervention, MK-0482.
Has an active uncontrolled infection requiring directed therapy.
Has immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, or disseminated intravascular coagulation.
Has known human immunodeficiency virus (HIV) and/or hepatitis B or C infections, or is known to be positive for HBsAg/ Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) or hepatitis C antibody or Ribonucleic acid (RNA).
Has known psychiatric or substance abuse disorders (verbally reported) that would interfere with the participant's ability to cooperate with the requirements of the study.
Is pregnant or breast feeding or expecting to conceive or father children within the projected duration of the study, starting with the Screening Visit through 120 days after the last dose of study intervention.
Has received systemic anticancer therapy, radiotherapy, or surgery within 2 weeks before the start of study treatment.
Has received hematopoietic cytokines (Granulocyte Colony Stimulating Factor (G-CSF), Granulocyte Macrophage (GM)-CSF, or erythropoietin) within 2 weeks prior to start of study treatment.
Has received a live or live attenuated vaccine within 30 days before the first dose of study medication.
Is currently participating and receiving study intervention in a study of an investigational agent or has participated and received study intervention in a study of an investigational agent or has used an investigational device within 14 days of administration of MK-0482.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director
Merck Sharp & Dohme LLC
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Roswell Park Cancer Institute ( Site 0006)
Buffalo
New York
14263
United States
University of Texas MD Anderson Cancer Center ( Site 0004)
Thirteen participants enrolled, of which 12 received study treatment in Part 1 of the study (dose-escalation).
Part 2 of the study (dose expansion) was not conducted due to early termination of the study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MK-0482 7.5 mg Q3W
Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for up to 35 cycles (approximately 24 months).
FG001
MK-0482 25 mg Q3W
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Oct 2, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Biological: MK-0482
Cmin (or Ctrough) was defined as the lowest concentration of MK-0482 reached during a dosing interval (time interval between administration of two doses). Blood samples were collected pre-dose and post-dose at designated timepoints to determine Cmin of MK-0482.
Cycle 1: Pre-dose and Days 1, 2, 4, 8, and 15 post-dose. Cycle=21 days.
Area Under the Plasma Concentration-Time Curve From Time Zero to 21 Days (AUC0-21) of MK-0482
AUC0-21 was defined as the area under the plasma concentration-time curve from time zero to 21 days. Blood samples were collected pre-dose and post-dose at designated timepoints to determine AUC0-21 of MK-0482.
Cycle 1: Pre-dose and Days 1, 2, 4, 8, and 15 post-dose. Cycle=21 days.
Time to Maximum Concentration (Tmax) of MK-0482
Tmax was defined as the time to maximum concentration of MK-0482 observed in plasma. Blood samples were collected pre-dose and post-dose at designated timepoints to determine Tmax of MK-0482.
Cycle 1: Pre-dose and Days 1, 2, 4, 8, and 15 post-dose. Cycle=21 days.
Plasma Elimination Terminal Half-life (t½) of MK-0482
t½ was defined as the time required to divide the MK-0482 plasma concentration by two after reaching pseudo-equilibrium. Blood samples were collected pre-dose and post-dose at designated timepoints to determine t½ of MK-0482.
Cycle 1: Pre-dose and Days 1, 2, 4, 8, and 15 post-dose. Cycle=21 days.
Complete Remission (CR) Rate
CR Rate was assessed by the investigator per 2017 European Leukemia Net (ELN) Response Criteria for Acute Myeloid Leukemia (AML) and was defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) ≥1.0 × 10^9/L (1000/µL); and platelet count ≥100 × 10^9/L (100,000/µL). The percentage of participants with CR (CR Rate) was reported for each arm.
Up to approximately 10 months
Composite CR Rate
Composite CR rate was assessed by the investigator per 2017 ELN Response Criteria for AML and was defined as CR plus CR with incomplete recovery (CRi). CR was defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 × 10^9/L (1000/µL); and platelet count ≥100 × 10^9/L (100,000/µL). CRi was defined as all CR criteria except for residual neutropenia (<1.0 × 10^9/L [1000/µL]) or thrombocytopenia (<100 × 10^9/L [100,000/µL]). The percentage of participants with Composite CR (Composite CR Rate) was reported for each arm.
Up to approximately 10 months
Objective Response Rate (ORR)
ORR was assessed by the investigator per 2017 ELN Response Criteria for AML and was defined as the combined percentage of participants with CR, CRi, and partial remission (PR). CR was defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 × 10^9/L (1000/µL); platelet count ≥100 × 10^9/L (100,000/µL)]. CRi was defined as all CR criteria except for residual neutropenia (<1.0 × 10^9/L [1000/µL]) or thrombocytopenia (<100 × 10^9/L [100,000/µL]). PR was defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pre-treatment bone marrow blast percentage by at least 50%). ORR was reported for each arm.
Up to approximately 10 months
Houston
Texas
77030
United States
Hadassah Medical Center ( Site 0100)
Jerusalem
9112001
Israel
Sheba Medical Center-Hemato Oncology ( Site 0101)
Ramat Gan
5262100
Israel
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 0301)
Salamanca
37007
Spain
Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
FG002
MK-0482 75 mg Q3W
Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
FG003
MK-0482 225 mg Q3W
Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
FG004
MK-0482 750 mg Q3W
Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
FG0001 subjects
FG0011 subjects
FG0025 subjects
FG0033 subjects
FG0043 subjects
Treated
FG0001 subjects
FG0011 subjects
FG0025 subjects
FG0033 subjects
FG0042 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0025 subjects
FG0033 subjects
FG0043 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0011 subjects
FG0025 subjects
FG0033 subjects
FG0041 subjects
Randomized By Mistake Without Study Treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MK-0482 7.5 mg Q3W
Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for up to 35 cycles (approximately 24 months).
BG001
MK-0482 25 mg Q3W
Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
BG002
MK-0482 75 mg Q3W
Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
BG003
MK-0482 225 mg Q3W
Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
BG004
MK-0482 750 mg Q3W
Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0011
BG0025
BG0033
BG0043
BG00513
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Participants
Title
Denominators
Categories
0 to 17 years
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Ethnicity (NIH/OMB)
Participants are indicated as "not reported" due to the risk of identification of a person.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Participants are indicated as "not reported" due to the risk of identification of a person.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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
Percentage of Participants Who Experienced a Dose-Limiting Toxicity (DLT)
DLTs were defined as any of the following assessed as treatment-related by investigator (with pre-specified exceptions): Grade (Gr) 4 non-hematologic toxicity; Gr 3 non-hematologic toxicity; Gr 3 or Gr 4 non-hematologic laboratory value if: clinically significant medical intervention was required to treat the participant, the abnormality led to hospitalization, the abnormality persisted for >1 week, electrolyte imbalances that lasted >48 hours despite optimal therapy, or the abnormality resulted in a drug-induced liver injury; Gr 4 neutropenia and/or thrombocytopenia lasting >14 days; >2 week-delay in starting Cycle 2 due to treatment-related toxicity; treatment-related toxicity resulting in treatment discontinuation during DLT evaluation period; missing >25% of MK-0482 dose during DLT evaluation period resulting from treatment-related adverse event (AE); or Gr 5 toxicity. The percentage of participants that experienced a DLT was reported for each arm.
The DLT evaluable population included all allocated participants in Part 1 (dose escalation) who received at least 1 dose of study intervention and met the criteria for DLT evaluability (i.e finished Cycle 1 without a DLT, or experienced a DLT in Cycle 1).
Posted
Number
80% Confidence Interval
Percentage of Participants
Cycle 1 (up to 21 days)
ID
Title
Description
OG000
MK-0482 7.5 mg Q3W
Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for up to 35 cycles (approximately 24 months).
OG001
MK-0482 25 mg Q3W
Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG002
MK-0482 75 mg Q3W
Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG003
MK-0482 225 mg Q3W
Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG004
MK-0482 750 mg Q3W
Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Units
Counts
Participants
OG0001
OG0011
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 55.3)
OG0010.0(0.0 to 55.3)
OG0020.0(0.0 to 23.5)
OG003
Primary
Number of Participants Who Experience at Least One Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced at least one AE was reported for each arm.
All allocated participants who received at least 1 dose of study intervention were analyzed.
Posted
Count of Participants
Participants
Up to approximately 10 months
ID
Title
Description
OG000
MK-0482 7.5 mg Q3W
Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for up to 35 cycles (approximately 24 months).
OG001
MK-0482 25 mg Q3W
Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG002
MK-0482 75 mg Q3W
Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG003
Primary
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE was reported for each arm.
All allocated participants who received at least 1 dose of study intervention were analyzed.
Posted
Count of Participants
Participants
Up to approximately 4 months
ID
Title
Description
OG000
MK-0482 7.5 mg Q3W
Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for up to 35 cycles (approximately 24 months).
OG001
MK-0482 25 mg Q3W
Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG002
MK-0482 75 mg Q3W
Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG003
Secondary
Maximum Concentration (Cmax) of MK-0482
Cmax was defined as the maximum concentration of MK-0482 observed in plasma. Blood samples were collected pre-dose and post-dose at designated timepoints to determine Cmax of MK-0482.
All allocated participants who received at least 1 dose of study intervention, were compliant with the study procedures, and had available data from at least 1 treatment dose were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1: Pre-dose and Days 1, 2, 4, 8, and 15 post-dose. Cycle=21 days.
ID
Title
Description
OG000
MK-0482 7.5 mg Q3W
Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for up to 35 cycles (approximately 24 months).
OG001
MK-0482 25 mg Q3W
Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG002
MK-0482 75 mg Q3W
Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Secondary
Minimum Concentration (Cmin) of MK-0482
Cmin (or Ctrough) was defined as the lowest concentration of MK-0482 reached during a dosing interval (time interval between administration of two doses). Blood samples were collected pre-dose and post-dose at designated timepoints to determine Cmin of MK-0482.
All allocated participants who received at least 1 dose of study intervention, were compliant with the study procedures, and had available data from at least 1 treatment dose were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1: Pre-dose and Days 1, 2, 4, 8, and 15 post-dose. Cycle=21 days.
ID
Title
Description
OG000
MK-0482 7.5 mg Q3W
Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for up to 35 cycles (approximately 24 months).
OG001
MK-0482 25 mg Q3W
Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG002
MK-0482 75 mg Q3W
Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Secondary
Area Under the Plasma Concentration-Time Curve From Time Zero to 21 Days (AUC0-21) of MK-0482
AUC0-21 was defined as the area under the plasma concentration-time curve from time zero to 21 days. Blood samples were collected pre-dose and post-dose at designated timepoints to determine AUC0-21 of MK-0482.
All allocated participants who received at least 1 dose of study intervention, were compliant with the study procedures, and had available data from at least 1 treatment dose were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*ng/mL
Cycle 1: Pre-dose and Days 1, 2, 4, 8, and 15 post-dose. Cycle=21 days.
ID
Title
Description
OG000
MK-0482 7.5 mg Q3W
Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for up to 35 cycles (approximately 24 months).
OG001
MK-0482 25 mg Q3W
Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG002
MK-0482 75 mg Q3W
Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Secondary
Time to Maximum Concentration (Tmax) of MK-0482
Tmax was defined as the time to maximum concentration of MK-0482 observed in plasma. Blood samples were collected pre-dose and post-dose at designated timepoints to determine Tmax of MK-0482.
All allocated participants who received at least 1 dose of study intervention, were compliant with the study procedures, and had available data from at least 1 treatment dose were analyzed.
Posted
Median
Full Range
Days
Cycle 1: Pre-dose and Days 1, 2, 4, 8, and 15 post-dose. Cycle=21 days.
ID
Title
Description
OG000
MK-0482 7.5 mg Q3W
Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for up to 35 cycles (approximately 24 months).
OG001
MK-0482 25 mg Q3W
Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG002
MK-0482 75 mg Q3W
Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Secondary
Plasma Elimination Terminal Half-life (t½) of MK-0482
t½ was defined as the time required to divide the MK-0482 plasma concentration by two after reaching pseudo-equilibrium. Blood samples were collected pre-dose and post-dose at designated timepoints to determine t½ of MK-0482.
All allocated participants who received at least 1 dose of study intervention, were compliant with the study procedures, and had available data from at least 1 treatment dose were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Days
Cycle 1: Pre-dose and Days 1, 2, 4, 8, and 15 post-dose. Cycle=21 days.
ID
Title
Description
OG000
MK-0482 7.5 mg Q3W
Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for up to 35 cycles (approximately 24 months).
OG001
MK-0482 25 mg Q3W
Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG002
MK-0482 75 mg Q3W
Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Secondary
Complete Remission (CR) Rate
CR Rate was assessed by the investigator per 2017 European Leukemia Net (ELN) Response Criteria for Acute Myeloid Leukemia (AML) and was defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) ≥1.0 × 10^9/L (1000/µL); and platelet count ≥100 × 10^9/L (100,000/µL). The percentage of participants with CR (CR Rate) was reported for each arm.
All allocated participants who received at least 1 dose of study intervention and had a baseline assessment were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 10 months
ID
Title
Description
OG000
MK-0482 7.5 mg Q3W
Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for up to 35 cycles (approximately 24 months).
OG001
MK-0482 25 mg Q3W
Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG002
MK-0482 75 mg Q3W
Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Secondary
Composite CR Rate
Composite CR rate was assessed by the investigator per 2017 ELN Response Criteria for AML and was defined as CR plus CR with incomplete recovery (CRi). CR was defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 × 10^9/L (1000/µL); and platelet count ≥100 × 10^9/L (100,000/µL). CRi was defined as all CR criteria except for residual neutropenia (<1.0 × 10^9/L [1000/µL]) or thrombocytopenia (<100 × 10^9/L [100,000/µL]). The percentage of participants with Composite CR (Composite CR Rate) was reported for each arm.
All allocated participants who received at least 1 dose of study intervention and had a baseline assessment were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 10 months
ID
Title
Description
OG000
MK-0482 7.5 mg Q3W
Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for up to 35 cycles (approximately 24 months).
OG001
MK-0482 25 mg Q3W
Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG002
MK-0482 75 mg Q3W
Secondary
Objective Response Rate (ORR)
ORR was assessed by the investigator per 2017 ELN Response Criteria for AML and was defined as the combined percentage of participants with CR, CRi, and partial remission (PR). CR was defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 × 10^9/L (1000/µL); platelet count ≥100 × 10^9/L (100,000/µL)]. CRi was defined as all CR criteria except for residual neutropenia (<1.0 × 10^9/L [1000/µL]) or thrombocytopenia (<100 × 10^9/L [100,000/µL]). PR was defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pre-treatment bone marrow blast percentage by at least 50%). ORR was reported for each arm.
All allocated participants who received at least 1 dose of study intervention and had a baseline assessment were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 10 months
ID
Title
Description
OG000
MK-0482 7.5 mg Q3W
Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for up to 35 cycles (approximately 24 months).
OG001
MK-0482 25 mg Q3W
Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Time Frame
Up to approximately 10 months
Description
All-Cause Mortality was reported for all randomized participants.
Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
MK-0482 7.5 mg Q3W
Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks [Q3W]) for up to 35 cycles (approximately 24 months).
1
1
1
1
1
1
EG001
MK-0482 25 mg Q3W
Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
1
1
1
1
0
1
EG002
MK-0482 75 mg Q3W
Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
5
5
3
5
4
5
EG003
MK-0482 225 mg Q3W
Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
3
3
2
3
3
3
EG004
MK-0482 750 mg Q3W
Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
1
3
2
2
2
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0021 events1 affected5 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected2 at risk
Myocarditis
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Peri-implantitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Partial seizures
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukocytosis
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected3 at risk
EG0041 events1 affected2 at risk
Vitreous floaters
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Chest pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Generalised oedema
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Influenza like illness
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Oedema
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Peripheral swelling
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Weight increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events2 affected5 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Muscle mass
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Monoparesis
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Urethral haemorrhage
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Rash papulosquamous
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG003
Haematoma
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with ICMJE authorship requirements.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG004
MK-0482 750 mg Q3W
Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Units
Counts
Participants
OG0001
OG0011
OG0025
OG0033
OG0042
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0025
OG0033
OG0042
MK-0482 225 mg Q3W
Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG004
MK-0482 750 mg Q3W
Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Units
Counts
Participants
OG0001
OG0011
OG0025
OG0033
OG0042
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG003
MK-0482 225 mg Q3W
Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG004
MK-0482 750 mg Q3W
Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Units
Counts
Participants
OG0001
OG0011
OG0025
OG0033
OG0042
Title
Denominators
Categories
Title
Measurements
OG0001490± NANA = Geometric coefficient of variation values were not reported when N \< 2.
OG0015610± NANA = Geometric coefficient of variation values were not reported when N \< 2.
OG00222000± 28.1
OG00353400± 31.0
OG004125000± 24.6
OG003
MK-0482 225 mg Q3W
Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG004
MK-0482 750 mg Q3W
Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Units
Counts
Participants
OG0001
OG0011
OG0025
OG0033
OG0042
Title
Denominators
Categories
Title
Measurements
OG0000.00± NANA = Geometric coefficient of variation values were not reported when N \< 2.
OG0010.00± NANA = Geometric coefficient of variation values were not reported when N \< 2.
OG002415± 2077.3
OG00311200± 34.6
OG00424500± 61.9
OG003
MK-0482 225 mg Q3W
Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG004
MK-0482 750 mg Q3W
Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Units
Counts
Participants
OG0001
OG0011
OG0025
OG0033
OG0042
Title
Denominators
Categories
Title
Measurements
OG0003110± NANA = Geometric coefficient of variation values were not reported when N \< 2.
OG00117200± NANA = Geometric coefficient of variation values were not reported when N \< 2.
OG002105000± 64.5
OG003521000± 22.9
OG004885000± 12.4
OG003
MK-0482 225 mg Q3W
Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG004
MK-0482 750 mg Q3W
Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Units
Counts
Participants
OG0001
OG0011
OG0025
OG0033
OG0042
Title
Denominators
Categories
Title
Measurements
OG0000.04(0.04 to 0.04)
OG0010.04(0.04 to 0.04)
OG0020.04(0.03 to 0.05)
OG0030.02(0.02 to 0.03)
OG0040.03(0.02 to 0.03)
OG003
MK-0482 225 mg Q3W
Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG004
MK-0482 750 mg Q3W
Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Units
Counts
Participants
OG0001
OG0011
OG0025
OG0033
OG0042
Title
Denominators
Categories
Title
Measurements
OG000NA± NANA = t½ and its corresponding geometric coefficient of variation were not calculated due to insufficient samples in the terminal phase to estimate lambda\_z.
OG0012.46± NANA = Geometric coefficient of variation values were not reported when N \< 2.
OG0023.69± 73.9
OG00311.2± 34.7
OG00411.2± 23.6
OG003
MK-0482 225 mg Q3W
Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG004
MK-0482 750 mg Q3W
Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Units
Counts
Participants
OG0001
OG0011
OG0025
OG0033
OG0041
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 97.5)
OG0010.0(0.0 to 97.5)
OG0020.0(0.0 to 52.2)
OG0030.0(0.0 to 70.8)
OG0040.0(0.0 to 97.5)
Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG003
MK-0482 225 mg Q3W
Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG004
MK-0482 750 mg Q3W
Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
Units
Counts
Participants
OG0001
OG0011
OG0025
OG0033
OG0041
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 97.5)
OG0010.0(0.0 to 97.5)
OG0020.0(0.0 to 52.2)
OG0030.0(0.0 to 70.8)
OG0040.0(0.0 to 97.5)
OG002
MK-0482 75 mg Q3W
Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG003
MK-0482 225 mg Q3W
Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
OG004
MK-0482 750 mg Q3W
Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).