A Study of Abemaciclib (LY2835219) in Combination With Ot... | NCT04238819 | Trialant
NCT04238819
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Mar 2, 2026Actual
Enrollment
47Actual
Phase
Phase 1Phase 2
Conditions
Relapsed Solid Tumor
Refractory Solid Tumor
Interventions
Abemaciclib
Irinotecan
Temozolomide
Dinutuximab
GM-CSF
Countries
United States
Australia
Belgium
France
Germany
Italy
Japan
Spain
Protocol Section
Identification Module
NCT ID
NCT04238819
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16950
Secondary IDs
ID
Type
Description
Link
I3Y-MC-JPCS
Other Identifier
Eli Lilly and Company
2019-002931-27
EudraCT Number
2023-506778-11-00
Other Identifier
EU Trial Number
Brief Title
A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma
Official Title
A Phase 1b/2 Study of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors and Abemaciclib in Combination With Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients With Relapsed/Refractory Neuroblastoma (Part C)
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Feb 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 9, 2020Actual
Primary Completion Date
Mar 15, 2024Actual
Completion Date
Aug 19, 2025Actual
First Submitted Date
Jan 22, 2020
First Submission Date that Met QC Criteria
Jan 22, 2020
First Posted Date
Jan 23, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Mar 14, 2025
Results First Submitted that Met QC Criteria
Jul 18, 2025
Results First Posted Date
Aug 6, 2025Actual
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
Feb 8, 2026
Last Update Posted Date
Mar 2, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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 study's purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did not respond or grew during other anti-cancer treatment. For each participant, the study is estimated to last up to 2 years.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Drug: Abemaciclib
Drug: Irinotecan
Drug: Temozolomide
Part A Cohort A-1
Experimental
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Drug: Abemaciclib
Drug: Irinotecan
Drug: Temozolomide
Part B Cohort B1
Experimental
Participants received:
Abemaciclib: 70 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Drug: Abemaciclib
Drug: Temozolomide
Part B Cohort B2
Experimental
Participants received:
Abemaciclib: 90 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Abemaciclib
Drug
Administered orally
Part A Cohort A-1
Part A Cohort A1
Part B Cohort B1
Part B Cohort B2
Part B Cohort B3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Recommended Phase 2 Dose (RP2D) of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A)
The RP2D of abemaciclib was determined based on the totality of safety, tolerability, and pharmacokinetic results. RP2D of abemaciclib in combination with 50 mg/m²/day irinotecan and 100 mg/m²/day temozolomide on days 1-5 of 21-day cycles was reported.
Cycles 1 and 2 (21 Day Cycles)
Number or Participants With Dose Limiting Toxicities (DLTs) in Part A
DLT was 1 of the following adverse events likely related to abemaciclib/combination and fulfils any 1 of the following criteria graded per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0:
Any non-hematologic Grade (G) ≥3 toxicity, except:
G3 diarrhea lasting <72 hour (h)
Acute irinotecan-associated diarrhea lasting <7 days
G≥3 nausea, vomiting, constipation that lasts <72 h
G3 mucositis/stomatitis lasting <72 h
G3 fever/infection
G≥3 electrolyte abnormality that lasts <72 h, is not complicated, and resolves spontaneously or responds to conventional medication;
G≥3 amylase/lipase that is not associated with symptoms/clinical manifestations of pancreatitis; or
AST/ALT elevation resolving to eligibility criteria within 7 days;
Hematologic toxicities considered a DLT:
A >14-day Cycle 2 delay due to neutropenia/thrombocytopenia
G≥3 thrombocytopenia with significant bleeding; or
G≥ 4 neutropenic fever
Cycle 1 (21 Day Cycle)
Maximum Tolerated Dose (MTD) of Abemaciclib in Part A
The MTD was defined as the highest dose level at which less than 33% of participants experienced a DLT.
Cycle 1 (21 Days)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC0-tlast) of Abemaciclib in Part A
PK: (AUC0-tlast) was reported.
Pre-dose, 1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Overall Response Rate (ORR): Part A
ORR: Percentage of participants with best response of CR or PR per Response Evaluation Criteria in Solid Tumors (RECIST) or Response Assessment in Neuro-Oncology (RANO).
RECIST was used for solid tumors and RANO was used for brain tumors.
CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO).
PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and >50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Parts A and B only:
Participants must be less than or equal to (≤)18 years of age.
Body weight greater than or equal to (≥)10 kilograms and body surface area (BSA) ≥0.5
Participants with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies.
For sites that are actively enrolling Parts B and C, participants with neuroblastoma who are eligible for Part C will be excluded from Part B unless approved by Lilly CRP/CRS.
Part C only:
Participants must be less than (<) 21 years of age.
Participants have a BSA ≥0.2 m².
Participants with first relapse/refractory neuroblastoma.
All Parts
Participants must have measurable or evaluable disease by RECIST v1.1 or RANO.
A Lansky score ≥50 for participants <16 years of age or Karnofsky score ≥50 for participants ≥16 years of age.
Participants must have discontinued all previous treatments for cancer or investigational agents and must have recovered from the acute effects to Grade ≤1 at the time of enrollment.
Able to swallow and/or have a gastric/nasogastric tube.
Adequate hematologic and organ function ≤2 weeks (14 days) prior to first dose of study drug.
Females of reproductive potential must have negative urine or serum pregnancy test at baseline (within 7 days prior to starting treatment).
Female participants of reproductive potential must agree to use highly effective contraceptive precautions during the trial. For abemaciclib, females should use contraception for at least 3 weeks following the last abemaciclib. For other study drugs, highly effective contraceptive precautions (and avoiding sperm donation) must be used according to their label.
Life expectancy of at least 8 weeks and able to complete at least 1 cycle of treatment.
Caregivers and participants willing to make themselves available for the duration of the trial.
Exclusion Criteria:
Received allogenic bone marrow or solid organ transplant.
Received live vaccination.
Intolerability or hypersensitivity to any of the study treatments or its components.
Diagnosed and/or treated additional malignancy within 3 years prior to enrollment that may affect the interpretation of results, with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected in situ cervical and/or breast cancers.
Pregnant or breastfeeding.
Active systemic infections.
Serious and/or uncontrolled preexisting medical condition(s) that would preclude participation in this study.
Parts A and C only: Have a bowel obstruction.
Prior treatment with drugs known to be strong inhibitors or inducers of isoenzyme cytochrome P450 3A (CYP3A) or strong inhibitors of uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) if the treatment cannot be discontinued or switched to a different medication at least 5 half-lives prior to starting study drug.
Received prior treatment with cyclin-dependent kinase (CDK) 4 & 6 inhibitor.
Part C only: Received prior systemic therapy for relapsed/refractory neuroblastoma.
Part C only, have received prior anti-GD2 therapy during induction phase.
Currently enrolled in any other clinical study involving an investigational product or non-approved use of a drug or device.
Has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
21 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Phoenix Children's Hospital
Phoenix
Arizona
85016
United States
The Regents of the University of California - Los Angeles (UCLA Pediatrics)
References Module
Citations
Not provided
See Also Links
Label
URL
A Study of Abemaciclib (LY2835219) in Combination With Temozolomide and Irinotecan and Abemaciclib in Combination With Temozolomide in Children and Young Adult Participants With Solid Tumors
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
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
Yes
No
No
Study Protocol
Jul 18, 2023
Mar 10, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Canada
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group 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
Drug: Abemaciclib
Drug: Temozolomide
Part B Cohort B3
Experimental
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Drug: Abemaciclib
Drug: Temozolomide
Part B Cohort B5
Experimental
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 150 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Drug: Abemaciclib
Drug: Temozolomide
Part C Cohort C1
Experimental
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Dinutuximab: 17.5mg/m²/day, administered IV on Days 2-5 of each cycle.
Granulocyte-macrophage colony-stimulating factor (GM-CSF): 250 μg/m²/day, administered subcutaneously (SC) on Days 6-12 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Drug: Abemaciclib
Drug: Irinotecan
Drug: Temozolomide
Drug: Dinutuximab
Drug: GM-CSF
Part B Cohort B5
Part C Cohort C1
LY2835219
Irinotecan
Drug
Administered IV
Part A Cohort A-1
Part A Cohort A1
Part C Cohort C1
Temozolomide
Drug
Administered orally
Part A Cohort A-1
Part A Cohort A1
Part B Cohort B1
Part B Cohort B2
Part B Cohort B3
Part B Cohort B5
Part C Cohort C1
Dinutuximab
Drug
Administered IV
Part C Cohort C1
GM-CSF
Drug
Administered SC
Part C Cohort C1
PK: (AUC0-tlast) of Irinotecan in Part A
PK: AUC0-tlast) was reported.
2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
PK: (AUC0-tlast) of Temozolomide in Part A
PK: AUC0-tlast was reported.
1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
RP2D of Abemaciclib in Combination With Temozolomide (Part B)
The RP2D of abemaciclib was determined based on the totality of safety, tolerability, and pharmacokinetic results. RP2D of abemaciclib in combination with 150 mg/m²/day temozolomide on days 1-5 of 21-day cycles was reported.
Cycles 1 and 2 (21 Day Cycles)
Number or Participants With DLTs in Part B
A DLT was 1 of the following adverse events likely related to abemaciclib/combination and fulfils any 1 of the following criteria graded as per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0:
Any non-hematologic Grade (G) ≥3 toxicity, except:
G3 diarrhea lasting <72 hr
Acute irinotecan-associated diarrhea lasting <7 days
G≥3 nausea, vomiting, constipation that lasts <72 hr
G3 mucositis/stomatitis lasting <72 hr
G3 fever/infection
G≥3 electrolyte abnormality that lasts <72 hr, is not complicated, and resolves spontaneously or responds to conventional medication;
G≥3 amylase/lipase that is not associated with symptoms/clinical manifestations of pancreatitis; or
AST/ALT elevation resolving to eligibility criteria within 7 days;
Hematologic toxicities considered a DLT:
A >14-day Cycle 2 delay due to neutropenia/thrombocytopenia
G≥3 thrombocytopenia with significant bleeding; or
G≥ 4 neutropenic fever
Cycle 1 (21 Day Cycle)
MTD of Abemaciclib in Part B
The MTD was defined as the highest dose level at which less than 33% of participants experienced a DLT.
Cycle 1 (21 Days)
PK: AUC0-tlast of Abemaciclib in Part B
PK: AUC0-tlast was reported.
Pre-dose, 1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
PK: AUC0-tlast of Temozolomide in Part B
PK: AUC0-tlast was reported.
1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
Number of Participants With Overall Response Rate (ORR) in Part C.
ORR: Number of participants with best response of Complete Response (CR), Partial Response (PR), or Minor Response (MR) per International Neuroblastoma Response Criteria (INRC).
CR is defined as complete response in all response components:
Primary Tumor: <10 mm residual soft tissue primary site and complete resolution of MIBG-avid tumors
Soft tissue and bone metastatic response: nonprimary target and nontarget lesions <10 mm and nodes identified as targets decreased to short axis <10mm and MIBG-avid update of nonprimary lesions completely resolved
Bone marrow response: no tumor infiltration on reassessment; disappearance of all target lesions;
PR is defined as PR in >1component and all other components are either CR, minimal disease (MD) (bone marrow only), PR (soft tissue or bone), or not involved (NI) and no components with progressive disease (PD).
MR is defined PR or CR in >1 component and SD in >1 component and no component with PD
Date of first dose to disease progression or death (Up to 25 Months)
Date of first dose to disease progression or death (Up to 25 Months)
Percentage of Participants With ORR: Part B
ORR: Percentage of participants with best response of CR or PR per Response Evaluation Criteria in Solid Tumors (RECIST) or Response Assessment in Neuro-Oncology (RANO).
RECIST was used for solid tumors and RANO was used for brain tumors.
CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO).
PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and >50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO).
Date of first dose to disease progression or death (Up to 25 Months)
Duration of Response (DoR): Parts A and B.
DoR is the time between first evidence of CR or PR and disease progression or death due to any cause.
RECIST was used for solid tumors and RANO was used for brain tumors.
CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO).
PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and >50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO).
Date of first evidence of a CR or PR to date of objective disease progression or death due to any cause (Up to 25 Months)
Duration of Response (DoR): Part C
DoR is the time between first evidence of CR, PR or MR and disease progression or death due to any cause.
CR, PR, and MR was as per International Neuroblastoma Response Criteria (INRC).
- CR is defined as complete response in all response components: Primary Tumor: <10 mm residual soft tissue primary site and complete resolution of MIBG-avid tumors Soft tissue and bone metastatic response: nonprimary target and nontarget lesions <10 mm and nodes identified as targets decreased to short axis <10mm and MIBG-avid update of nonprimary lesions completely resolved Bone marrow response: no tumor infiltration on reassessment; disappearance of all target lesions;
PR is defined as PR in >1 component and all other components are either CR, minimal disease (MD) (bone marrow only), PR (soft tissue or bone), or not involved (NI) and no components with progressive disease (PD).
MR is defined PR or CR in >1 component and SD in >1 component and no component with PD
Date of first evidence of a CR, PR, or MR to date of objective disease progression or death due to any cause (Up to 25 Months)
Percentage of Participants With Clinical Benefit Rate (CBR): Part A
The CBR is the percentage of participants with a best response of CR or PR, or Stable Disease (SD) for at least 6 months.
RECIST was used for solid tumors and RANO was used for brain tumors.
CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO).
PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and >50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO).
SD is neither sufficient shrinkage nor sufficient increase in the size of the tumor.
Date of first dose to disease progression or death due to any cause (Up to 25 Months)
Percentage of Participants With CBR: Part B
The CBR is the percentage of participants with a best response of CR or PR, or SD for at least 6 months.
RECIST was used for solid tumors and RANO was used for brain tumors.
CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO).
PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and >50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO).
SD is neither sufficient shrinkage nor sufficient increase in the size of the tumor.
Date of first dose to disease progression or death due to any cause (Up to 25 Months)
Percentage of Participants With Disease Control Rate (DCR): Part A
DCR: Percentage of participants with a best overall response of CR, PR, and SD. RECIST was used for solid tumors and RANO was used for brain tumors.
CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO).
PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and >50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO).
SD is neither sufficient shrinkage nor sufficient increase in the size of the tumor.
Date of first dose to measured progressive disease (Up to 25 Months)
Percentage of Participants With DCR: Part B
DCR: Percentage of participants with a best overall response of CR, PR, and SD. RECIST was used for solid tumors and RANO was used for brain tumors.
CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO).
PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and >50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO).
SD is neither sufficient shrinkage nor sufficient increase in the size of the tumor.
Date of first dose to measured progressive disease (Up to 25 Months)
Progression-Free Survival (PFS): Part C
Progression-free survival is measured as the time from first dose of study drug to progressive disease or death, whichever occurs first. PFS for Part C was reported.
Date of first dose to progressive disease or death (Up to 25 Months)
Abemaciclib Tablet Acceptability
Participants were evaluated for abemaciclib acceptability (palatability and ease of administration) by asking a question - " Was it easy or difficult for the study subject to swallow the abemaciclib today?" Participants or their caregivers or both could respond using the following possible answers: Very difficult, difficult, neither easy nor difficult, easy, or very easy.
Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (21 Day Cycles)
Los Angeles
California
90095-1752
United States
Kaiser Permanente Oakland
Oakland
California
94611
United States
Kaiser Permanente Roseville
Roseville
California
95661
United States
Kaiser Permanente Santa Clara
Santa Clara
California
95051
United States
Riley Hospital for Children at Indiana University Health
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
FG002
Part B Cohort B1
Participants received:
Abemaciclib: 70 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
FG003
Part B Cohort B2
Participants received:
Abemaciclib: 90 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
FG004
Part B Cohort B3
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
FG005
Part B Cohort B5
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 150 mg/m²/day, administered orally on Days 1-5 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
FG006
Part C Cohort C1
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Dinutuximab: 17.5mg/m²/day, administered IV on Days 2-5 of each cycle.
Granulocyte-macrophage colony-stimulating factor (GM-CSF): 250 μg/m²/day, administered subcutaneously (SC) on Days 6-12 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
FG0007 subjects
FG00113 subjects
FG0023 subjects
FG0039 subjects
FG0043 subjects
FG00511 subjects
FG0061 subjects
Received At Least One Dose of Study Drug
FG0007 subjects
FG00113 subjects
FG0023 subjects
FG0039 subjects
FG0043 subjects
FG00511 subjects
FG0061 subjects
COMPLETED
A participant was identified as having completed the study if the participant died while on the study or the participant discontinued study treatment and completed the follow-up period at the time of the final analysis.
FG0007 subjects
FG00112 subjects
FG0023 subjects
FG0037 subjects
FG0043 subjects
FG00510 subjects
FG0060 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
Type
Comment
Reasons
Discontinued study treatment, but follow-up visit was not completed due to primary study condition
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Withdrawal by Parent/Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
All participants who received at least one dose of the study drug.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
BG001
Part A Cohort A-1
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
BG002
Part B Cohort B1
Participants received:
Abemaciclib: 70 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
BG003
Part B Cohort B2
Participants received:
Abemaciclib: 90 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
BG004
Part B Cohort B3
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
BG005
Part B Cohort B5
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 150 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
BG006
Part C Cohort C1
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Dinutuximab: 17.5mg/m²/day, administered IV on Days 2-5 of each cycle.
Granulocyte-macrophage colony-stimulating factor (GM-CSF): 250 μg/m²/day, administered subcutaneously (SC) on Days 6-12 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0007
BG00113
BG0023
BG0039
BG0043
BG00511
BG0061
BG00747
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00012.9± 3.3
BG00112.2± 3.2
BG00212.3± 4.7
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0016
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
France
Title
Measurements
BG0000
BG0012
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
Recommended Phase 2 Dose (RP2D) of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A)
The RP2D of abemaciclib was determined based on the totality of safety, tolerability, and pharmacokinetic results. RP2D of abemaciclib in combination with 50 mg/m²/day irinotecan and 100 mg/m²/day temozolomide on days 1-5 of 21-day cycles was reported.
All participants in Part A who received at least one dose of abemaciclib and had evaluable data for this outcome.
Posted
Number
milligrams/squared meters (mg/m²) BID
Cycles 1 and 2 (21 Day Cycles)
ID
Title
Description
OG000
Part A - Abemaciclib
Cohort A1: 70 mg/m² abemaciclib administered orally BID in combination with 50 mg/m²/day irinotecan administered IV on Days 1-5 of each 21-day cycle and 100 mg/m²/day temozolomide administered orally on Days 1-5 of each 21-day cycle.
Cohort A-1: 55 mg/m² abemaciclib administered orally BID in combination with 50 mg/m²/day irinotecan administered IV on Days 1-5 of each 21-day cycle and 100 mg/m²/day temozolomide administered orally on Days 1-5 of each 21-day cycle.
Units
Counts
Participants
OG00020
Title
Denominators
Categories
Title
Measurements
OG00055
Primary
Number or Participants With Dose Limiting Toxicities (DLTs) in Part A
DLT was 1 of the following adverse events likely related to abemaciclib/combination and fulfils any 1 of the following criteria graded per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0:
Any non-hematologic Grade (G) ≥3 toxicity, except:
G3 diarrhea lasting <72 hour (h)
Acute irinotecan-associated diarrhea lasting <7 days
G≥3 nausea, vomiting, constipation that lasts <72 h
G3 mucositis/stomatitis lasting <72 h
G3 fever/infection
G≥3 electrolyte abnormality that lasts <72 h, is not complicated, and resolves spontaneously or responds to conventional medication;
G≥3 amylase/lipase that is not associated with symptoms/clinical manifestations of pancreatitis; or
AST/ALT elevation resolving to eligibility criteria within 7 days;
Hematologic toxicities considered a DLT:
A >14-day Cycle 2 delay due to neutropenia/thrombocytopenia
G≥3 thrombocytopenia with significant bleeding; or
G≥ 4 neutropenic fever
All participants in Part A who received at least one dose of the study drug and had evaluable data for this outcome.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Primary
Maximum Tolerated Dose (MTD) of Abemaciclib in Part A
The MTD was defined as the highest dose level at which less than 33% of participants experienced a DLT.
All part A participants who received at least one dose of abemaciclib and had evaluable data for this outcome.
Posted
Number
mg/m² BID
Cycle 1 (21 Days)
ID
Title
Description
OG000
Part A - Abemaciclib
Cohort A1: 70 mg/m² abemaciclib administered orally BID in combination with 50 mg/m²/day irinotecan administered IV on Days 1-5 of each 21-day cycle and 100 mg/m²/day temozolomide administered orally on Days 1-5 of each 21-day cycle.
Cohort A-1: 55 mg/m² abemaciclib administered orally BID in combination with 50 mg/m²/day irinotecan administered IV on Days 1-5 of each 21-day cycle and 100 mg/m²/day temozolomide administered orally on Days 1-5 of each 21-day cycle.
Units
Counts
Participants
OG000
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC0-tlast) of Abemaciclib in Part A
PK: (AUC0-tlast) was reported.
All participants in Part A who received at least one dose of abemaciclib and had evaluable PK data. Per planned analysis, PK analysis was performed as per the dose of study drug received.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram *hour per milliliter (ng*h/mL)
Pre-dose, 1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
ID
Title
Description
OG000
Part A: 70 mg/m² Abemaciclib
All part A participants who received 70 mg/m² abemaciclib were included under this arm.
OG001
Part A: 55 mg/m² Abemaciclib
All part A participants who received 55 mg/m² abemaciclib were included under this arm.
Units
Counts
Participants
OG000
Primary
PK: (AUC0-tlast) of Irinotecan in Part A
PK: AUC0-tlast) was reported.
All Part A participants who received at least one dose of irinotecan and had evaluable PK data. Per planned analysis, PK analysis was performed as per the dose of drug received.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
ID
Title
Description
OG000
Part A: 50 mg/m²/Day Irinotecan
All part A participants who received 50 mg/m²/day irinotecan were included under this arm.
Units
Counts
Participants
OG000
Primary
PK: (AUC0-tlast) of Temozolomide in Part A
PK: AUC0-tlast was reported.
All Part A participants who received at least one dose of temozolomide and had evaluable PK data. Per planned analysis, PK analysis was performed as per the dose of drug received.
Posted
Geometric Least Squares Mean
Geometric Coefficient of Variation
ng*h/mL
1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
ID
Title
Description
OG000
Part A: 100 mg/m²/Day Temozolomide
All part A participants who received 100 mg/m²/day temozolomide were included under this arm.
Units
Counts
Participants
OG000
Primary
RP2D of Abemaciclib in Combination With Temozolomide (Part B)
The RP2D of abemaciclib was determined based on the totality of safety, tolerability, and pharmacokinetic results. RP2D of abemaciclib in combination with 150 mg/m²/day temozolomide on days 1-5 of 21-day cycles was reported.
All participants in Part B who received at least one dose of abemaciclib and had evaluable data for this outcome.
Posted
Number
mg/m² BID
Cycles 1 and 2 (21 Day Cycles)
ID
Title
Description
OG000
Part B - Abemaciclib
Participants received:
Abemaciclib: 70 mg/m² or 90 mg/m² or 115 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day or 150 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Units
Counts
Participants
OG000
Primary
Number or Participants With DLTs in Part B
A DLT was 1 of the following adverse events likely related to abemaciclib/combination and fulfils any 1 of the following criteria graded as per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0:
Any non-hematologic Grade (G) ≥3 toxicity, except:
G3 diarrhea lasting <72 hr
Acute irinotecan-associated diarrhea lasting <7 days
G≥3 nausea, vomiting, constipation that lasts <72 hr
G3 mucositis/stomatitis lasting <72 hr
G3 fever/infection
G≥3 electrolyte abnormality that lasts <72 hr, is not complicated, and resolves spontaneously or responds to conventional medication;
G≥3 amylase/lipase that is not associated with symptoms/clinical manifestations of pancreatitis; or
AST/ALT elevation resolving to eligibility criteria within 7 days;
Hematologic toxicities considered a DLT:
A >14-day Cycle 2 delay due to neutropenia/thrombocytopenia
G≥3 thrombocytopenia with significant bleeding; or
G≥ 4 neutropenic fever
All participants in Part B who received at least one dose of the study drug and had evaluable data for this outcome.
Posted
Count of Participants
Participants
No
Cycle 1 (21 Day Cycle)
ID
Title
Description
OG000
Part B Cohort B1
Participants received:
Abemaciclib: 70 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG001
Primary
MTD of Abemaciclib in Part B
The MTD was defined as the highest dose level at which less than 33% of participants experienced a DLT.
All participants in Part B who received at least one dose of abemaciclib and had evaluable data for this outcome.
Posted
Number
mg/m² BID
Cycle 1 (21 Days)
ID
Title
Description
OG000
Part B - Abemaciclib
Participants received:
Abemaciclib: 70 mg/m² or 90 mg/m² or 115 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day or 150 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Units
Counts
Participants
OG000
Primary
PK: AUC0-tlast of Abemaciclib in Part B
PK: AUC0-tlast was reported.
All participants in Part B who received at least one dose of abemaciclib and had evaluable PK data. Per planned analysis, PK analysis was performed as per the dose of study drug received.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Pre-dose, 1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
ID
Title
Description
OG000
Part B: 70 mg/m² Abemaciclib
All part B participants who received 70 mg/m² abemaciclib were included under this arm.
OG001
Part B: 90 mg/m² Abemaciclib
All part B participants who received 90 mg/m² abemaciclib were included under this arm.
OG002
Part B: 115 mg/m² Abemaciclib
All part B participants who received 115 mg/m² abemaciclib were included under this arm.
Units
Counts
Participants
Primary
PK: AUC0-tlast of Temozolomide in Part B
PK: AUC0-tlast was reported.
All Part B participants in who received at least one dose of temozolomide and had evaluable PK data. Per planned analysis, PK analysis was performed as per the dose of drug received.
Posted
Geometric Least Squares Mean
Geometric Coefficient of Variation
ng*h/mL
1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
ID
Title
Description
OG000
Part B: 100 mg/m²/Day Temozolomide
All part B participants who received 100 mg/m²/day temozolomide were included under this arm.
OG001
Part B: 150 mg/m²/Day Temozolomide
All part B participants who received 150 mg/m²/day temozolomide were included under this arm.
Units
Counts
Participants
OG000
Primary
Number of Participants With Overall Response Rate (ORR) in Part C.
ORR: Number of participants with best response of Complete Response (CR), Partial Response (PR), or Minor Response (MR) per International Neuroblastoma Response Criteria (INRC).
CR is defined as complete response in all response components:
Primary Tumor: <10 mm residual soft tissue primary site and complete resolution of MIBG-avid tumors
Soft tissue and bone metastatic response: nonprimary target and nontarget lesions <10 mm and nodes identified as targets decreased to short axis <10mm and MIBG-avid update of nonprimary lesions completely resolved
Bone marrow response: no tumor infiltration on reassessment; disappearance of all target lesions;
PR is defined as PR in >1component and all other components are either CR, minimal disease (MD) (bone marrow only), PR (soft tissue or bone), or not involved (NI) and no components with progressive disease (PD).
MR is defined PR or CR in >1 component and SD in >1 component and no component with PD
All part C participants who received at least one dose of study drug. However, Part C was terminated early and only 1 participant was enrolled in this part.
Posted
Count of Participants
Participants
No
Date of first dose to disease progression or death (Up to 25 Months)
ID
Title
Description
OG000
Part C Cohort C1
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Dinutuximab: 17.5mg/m²/day, administered IV on Days 2-5 of each cycle.
Granulocyte-macrophage colony-stimulating factor (GM-CSF): 250 μg/m²/day, administered subcutaneously (SC) on Days 6-12 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Secondary
Percentage of Participants With Overall Response Rate (ORR): Part A
ORR: Percentage of participants with best response of CR or PR per Response Evaluation Criteria in Solid Tumors (RECIST) or Response Assessment in Neuro-Oncology (RANO).
RECIST was used for solid tumors and RANO was used for brain tumors.
CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO).
PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and >50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO).
All participants in Part A who received at least one dose of the study drug and had evaluable data for this outcome. Per pre-specified statistical analysis plan, analysis was performed as per the study treatments received.
Posted
Number
95% Confidence Interval
Percentage of participants
Date of first dose to disease progression or death (Up to 25 Months)
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Secondary
Percentage of Participants With ORR: Part B
ORR: Percentage of participants with best response of CR or PR per Response Evaluation Criteria in Solid Tumors (RECIST) or Response Assessment in Neuro-Oncology (RANO).
RECIST was used for solid tumors and RANO was used for brain tumors.
CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO).
PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and >50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO).
All participants in Part B who received at least one dose of the study drug and had evaluable data for this outcome. Per pre-specified statistical analysis plan, analysis was performed as per the study treatments received.
Posted
Number
95% Confidence Interval
Percentage of participants
Date of first dose to disease progression or death (Up to 25 Months)
ID
Title
Description
OG000
Part B Cohort B1
Participants received:
Abemaciclib: 70 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Secondary
Duration of Response (DoR): Parts A and B.
DoR is the time between first evidence of CR or PR and disease progression or death due to any cause.
RECIST was used for solid tumors and RANO was used for brain tumors.
CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO).
PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and >50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO).
All participants in Parts A and B who received at least one dose of the study drug and had evaluable data for this outcome. Per pre-specified statistical analysis plan, analysis was performed as per the study treatments received.
Posted
Median
95% Confidence Interval
Months
Date of first evidence of a CR or PR to date of objective disease progression or death due to any cause (Up to 25 Months)
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Secondary
Duration of Response (DoR): Part C
DoR is the time between first evidence of CR, PR or MR and disease progression or death due to any cause.
CR, PR, and MR was as per International Neuroblastoma Response Criteria (INRC).
- CR is defined as complete response in all response components: Primary Tumor: <10 mm residual soft tissue primary site and complete resolution of MIBG-avid tumors Soft tissue and bone metastatic response: nonprimary target and nontarget lesions <10 mm and nodes identified as targets decreased to short axis <10mm and MIBG-avid update of nonprimary lesions completely resolved Bone marrow response: no tumor infiltration on reassessment; disappearance of all target lesions;
PR is defined as PR in >1 component and all other components are either CR, minimal disease (MD) (bone marrow only), PR (soft tissue or bone), or not involved (NI) and no components with progressive disease (PD).
MR is defined PR or CR in >1 component and SD in >1 component and no component with PD
All participants in Part C who received at least one dose of the study drug and had evaluable data for this outcome.
Posted
Median
95% Confidence Interval
Months
Date of first evidence of a CR, PR, or MR to date of objective disease progression or death due to any cause (Up to 25 Months)
ID
Title
Description
OG000
Part C Cohort C1
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Dinutuximab: 17.5mg/m²/day, administered IV on Days 2-5 of each cycle.
Granulocyte-macrophage colony-stimulating factor (GM-CSF): 250 μg/m²/day, administered subcutaneously (SC) on Days 6-12 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Secondary
Percentage of Participants With Clinical Benefit Rate (CBR): Part A
The CBR is the percentage of participants with a best response of CR or PR, or Stable Disease (SD) for at least 6 months.
RECIST was used for solid tumors and RANO was used for brain tumors.
CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO).
PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and >50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO).
SD is neither sufficient shrinkage nor sufficient increase in the size of the tumor.
All participants in Part A who received at least one dose of the study drug and had evaluable data for this outcome. Per pre-specified statistical analysis plan, analysis was performed as per the study treatments received.
Posted
Number
95% Confidence Interval
Percentage of participants
Date of first dose to disease progression or death due to any cause (Up to 25 Months)
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Secondary
Percentage of Participants With CBR: Part B
The CBR is the percentage of participants with a best response of CR or PR, or SD for at least 6 months.
RECIST was used for solid tumors and RANO was used for brain tumors.
CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO).
PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and >50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO).
SD is neither sufficient shrinkage nor sufficient increase in the size of the tumor.
All participants in Part B who received at least one dose of the study drug and had evaluable data for this outcome. Per pre-specified statistical analysis plan, analysis was performed as per the study treatments received.
Posted
Number
95% Confidence Interval
Percentage of participants
Date of first dose to disease progression or death due to any cause (Up to 25 Months)
ID
Title
Description
OG000
Part B Cohort B1
Participants received:
Abemaciclib: 70 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Secondary
Percentage of Participants With Disease Control Rate (DCR): Part A
DCR: Percentage of participants with a best overall response of CR, PR, and SD. RECIST was used for solid tumors and RANO was used for brain tumors.
CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO).
PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and >50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO).
SD is neither sufficient shrinkage nor sufficient increase in the size of the tumor.
All participants in Part A who received at least one dose of the study drug and had evaluable data for this outcome. Per pre-specified statistical analysis plan, analysis was performed as per the study treatments received.
Posted
Number
95% Confidence Interval
Percentage of participants
Date of first dose to measured progressive disease (Up to 25 Months)
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Secondary
Percentage of Participants With DCR: Part B
DCR: Percentage of participants with a best overall response of CR, PR, and SD. RECIST was used for solid tumors and RANO was used for brain tumors.
CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO).
PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and >50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO).
SD is neither sufficient shrinkage nor sufficient increase in the size of the tumor.
All participants in Part B who received at least one dose of the study drug and had evaluable data for this outcome. Per pre-specified statistical analysis plan, analysis was performed as per the study treatments received.
Posted
Number
95% Confidence Interval
Percentage of participants
Date of first dose to measured progressive disease (Up to 25 Months)
ID
Title
Description
OG000
Part B Cohort B1
Participants received:
Abemaciclib: 70 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Secondary
Progression-Free Survival (PFS): Part C
Progression-free survival is measured as the time from first dose of study drug to progressive disease or death, whichever occurs first. PFS for Part C was reported.
All part C participants who received at least one dose of study drug. However, Part C was terminated early and only 1 participant was enrolled in this part.
Posted
Number
Months
Date of first dose to progressive disease or death (Up to 25 Months)
ID
Title
Description
OG000
Part C Cohort C1
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Dinutuximab: 17.5mg/m²/day, administered IV on Days 2-5 of each cycle.
Granulocyte-macrophage colony-stimulating factor (GM-CSF): 250 μg/m²/day, administered subcutaneously (SC) on Days 6-12 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Units
Counts
Participants
OG000
Secondary
Abemaciclib Tablet Acceptability
Participants were evaluated for abemaciclib acceptability (palatability and ease of administration) by asking a question - " Was it easy or difficult for the study subject to swallow the abemaciclib today?" Participants or their caregivers or both could respond using the following possible answers: Very difficult, difficult, neither easy nor difficult, easy, or very easy.
All participants in Parts A and B, who received at least one dose of abemaciclib and had evaluable data for this outcome. Per protocol, data were summarized by responses provided by participants, and/or caregivers on the acceptability of the abemaciclib received on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1.
Posted
Count of Participants
Participants
No
Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (21 Day Cycles)
ID
Title
Description
OG000
Part A Cohort A1 (Caregiver Responses - Cycle 1 Day 1)
Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Time Frame
Baseline Up To 2.2 years
Description
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. The adverse events were analyzed and reported according to the study treatments pre-specified in the protocol.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Units
Counts
Participants
OG0007
OG00113
Title
Denominators
Categories
Title
Measurements
OG0003
OG0011
20
Title
Denominators
Categories
Title
Measurements
OG00055
6
OG00113
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG0006
ParticipantsOG00113
Title
Measurements
OG000730± 33
OG001534± 116
Cycle 2, Day 1
ParticipantsOG0002
ParticipantsOG0019
Title
Measurements
OG000NA± NAGeometric Mean and Geometric Coefficient of Variation couldn't be calculated as there were only two participants. Individual values reported: 373.72 ng\*h/mL and 3373.97 ng\*h/mL.
OG001
20
Title
Denominators
Categories
Cycle 1, Day 1
Title
Measurements
OG0001450± 37
Cycle 2, Day 1
Title
Measurements
OG0001240± 58
19
Title
Denominators
Categories
Cycle 1, Day 1
Title
Measurements
OG00014400± 23
Cycle 2, Day 1
Title
Measurements
OG00012200± 44
26
Title
Denominators
Categories
Title
Measurements
OG000115
Part B Cohort B2
Participants received:
Abemaciclib: 90 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG002
Part B Cohort B3
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG003
Part B Cohort B5
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 150 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Units
Counts
Participants
OG0003
OG0019
OG0023
OG00311
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0031
26
Title
Denominators
Categories
Title
Measurements
OG000NAInsufficient number of participants experienced DLT. Thus, MTD could not be calculated.
OG0003
OG0018
OG00214
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG0003
ParticipantsOG0018
ParticipantsOG00214
Title
Measurements
OG000566± 104
OG001728± 60
OG002728± 77
Cycle 2, Day 1
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG00210
Title
Measurements
OG000
13
OG00111
Title
Denominators
Categories
Cycle 1, Day 1
ParticipantsOG00013
ParticipantsOG00111
Title
Measurements
OG00015800± 19
OG00124300± 13
Cycle 2, Day 1
ParticipantsOG00013
ParticipantsOG00110
Title
Measurements
OG00015700± 21
OG001
Units
Counts
Participants
OG0001
Title
Denominators
Categories
Title
Measurements
OG0001
OG001
Part A Cohort A-1
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Units
Counts
Participants
OG0007
OG00113
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)None of the participants achieved ORR. Thus, upper and lower limit of confidence interval values could not be calculated.
OG0017.7(0.0 to 22.2)
OG001
Part B Cohort B2
Participants received:
Abemaciclib: 90 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG002
Part B Cohort B3
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG003
Part B Cohort B5
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 150 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Units
Counts
Participants
OG0003
OG0019
OG0023
OG00311
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)None of the participants achieved ORR. Thus, upper and lower limits of confidence intervals could not be calculated.
OG0010(NA to NA)None of the participants achieved ORR. Thus, upper and lower limits of confidence intervals could not be calculated.
OG00233.3(0.0 to 86.7)
OG00318.2(0.0 to 41.0)
OG001
Part A Cohort A-1
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG002
Part B Cohort B1
Participants received:
Abemaciclib: 70 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG003
Part B Cohort B2
Participants received:
Abemaciclib: 90 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG004
Part B Cohort B3
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG005
Part B Cohort B5
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 150 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Units
Counts
Participants
OG0000
OG0011
OG0020
OG0030
OG0041
OG0052
Title
Denominators
Categories
Title
Measurements
OG00122.59(NA to NA)Only 1 participant had events, hence confidence interval limits could not be calculated.
OG0047.82(NA to NA)Only 1 participant had events, hence confidence interval limits could not be calculated.
OG0050.03(NA to NA)Upper and lower limit confidence intervals cannot be calculated as both participants had the same Duration of Response of 0.03 months.
Units
Counts
Participants
OG0001
Title
Denominators
Categories
Title
Measurements
OG0001.61(NA to NA)Only 1 participant had events, hence confidence interval limits could not be calculated.
OG001
Part A Cohort A-1
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Units
Counts
Participants
OG0007
OG00113
Title
Denominators
Categories
Title
Measurements
OG00014.3(0.0 to 40.2)
OG00130.8(5.7 to 55.9)
OG001
Part B Cohort B2
Participants received:
Abemaciclib: 90 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG002
Part B Cohort B3
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG003
Part B Cohort B5
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 150 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Units
Counts
Participants
OG0003
OG0019
OG0023
OG00311
Title
Denominators
Categories
Title
Measurements
OG00033.3(0.0 to 86.7)
OG0010(NA to NA)None of the participants achieved CBR. Thus, upper and lower limits of confidence intervals could not be calculated.
OG00233.3(0.0 to 86.7)
OG00318.2(0.0 to 41.0)
OG001
Part A Cohort A-1
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Units
Counts
Participants
OG0007
OG00113
Title
Denominators
Categories
Title
Measurements
OG00071.4(38.0 to 100.0)
OG00153.8(26.7 to 80.9)
OG001
Part B Cohort B2
Participants received:
Abemaciclib: 90 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG002
Part B Cohort B3
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG003
Part B Cohort B5
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 150 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Units
Counts
Participants
OG0003
OG0019
OG0023
OG00311
Title
Denominators
Categories
Title
Measurements
OG00033.3(0.0 to 86.7)
OG00155.6(23.1 to 88.0)
OG002100(100.0 to 100.0)
OG00336.4(7.9 to 64.8)
1
Title
Denominators
Categories
Title
Measurements
OG0002.9
OG002
Part A Cohort A1 (Caregiver Responses - Cycle 2 Day 1)
Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG006
Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 1)
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG007
Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 15)
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG008
Part A Cohort A-1(Caregiver Responses - Cycle 2 Day 1)
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG009
Part A Cohort A-1(Participant Responses - Cycle 1 Day 1)
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG010
Part A Cohort A-1(Participant Responses - Cycle 1 Day 15)
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG011
Part A Cohort A-1(Participant Responses - Cycle 2 Day 1)
Participants received:
Abemaciclib: 55 mg/m², administered orally BID.
Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG012
Part B Cohort B1 (Caregiver Responses - Cycle 1 Day 1)
Participants received:
Abemaciclib: 70 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG013
Part B Cohort B1 (Caregiver Responses - Cycle 1 Day 15)
Participants received:
Abemaciclib: 70 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG014
Part B Cohort B1 (Caregiver Responses - Cycle 2 Day 1)
Participants received:
Abemaciclib: 70 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG015
Part B Cohort B1 (Participant Responses - Cycle 1 Day 1)
Participants received:
Abemaciclib: 70 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG016
Part B Cohort B1 (Participant Responses - Cycle 1 Day 15)
Participants received:
Abemaciclib: 70 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG017
Part B Cohort B1 (Participant Responses - Cycle 2 Day 1)
Participants received:
Abemaciclib: 70 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG018
Part B Cohort B2 (Caregiver Responses - Cycle 1 Day 1)
Participants received:
Abemaciclib: 90 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG019
Part B Cohort B2 (Caregiver Responses - Cycle 1 Day 15)
Participants received:
Abemaciclib: 90 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG020
Part B Cohort B2 (Caregiver Responses - Cycle 2 Day 1)
Participants received:
Abemaciclib: 90 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG021
Part B Cohort B2 (Participant Responses - Cycle 1 Day 1)
Participants received:
Abemaciclib: 90 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG022
Part B Cohort B2 (Participant Responses - Cycle 1 Day 15)
Participants received:
Abemaciclib: 90 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG023
Part B Cohort B2 (Participant Responses - Cycle 2 Day 1)
Participants received:
Abemaciclib: 90 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG024
Part B Cohort B3 (Caregiver Responses - Cycle 1 Day 1)
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG025
Part B Cohort B3 (Caregiver Responses - Cycle 1 Day 15)
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG026
Part B Cohort B3 (Caregiver Responses - Cycle 2 Day 1)
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG027
Part B Cohort B3 (Participant Responses - Cycle 1 Day 1)
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG028
Part B Cohort B3 (Participant Responses - Cycle 1 Day 15)
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG029
Part B Cohort B3 (Participant Responses - Cycle 2 Day 1)
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG030
Part B Cohort B5 (Caregiver Responses - Cycle 1 Day 1)
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 150 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG031
Part B Cohort B5 (Caregiver Responses - Cycle 1 Day 15)
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 150 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG032
Part B Cohort B5 (Caregiver Responses - Cycle 2 Day 1)
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 150 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG033
Part B Cohort B5 (Participant Responses - Cycle 1 Day 1)
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 150 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG034
Part B Cohort B5 (Participant Responses - Cycle 1 Day 15)
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 150 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
OG035
Part B Cohort B5 (Participant Responses - Cycle 2 Day 1)
Participants received:
Abemaciclib: 115 mg/m², administered orally BID.
Temozolomide: 150 mg/m²/day, administered orally on Days 1-5 of each cycle.
Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Units
Counts
Participants
OG0003
OG0012
OG0025
OG0037
OG0045
OG0056
OG0066
OG0074
OG0087
OG00910
OG0108
OG0118
OG0122
OG0131
OG0141
OG0152
OG0161
OG0172
OG0185
OG0194
OG0204
OG0216
OG0226
OG0236
OG0241
OG0251
OG0261
OG0273
OG0283
OG0293
OG0306
OG0317
OG0324
OG0339
OG0349
OG0359
Title
Denominators
Categories
Title
Measurements
Very easy to swallow tablet
OG0001
OG0011
OG0023
OG0034
OG0044
OG0054
OG0066
OG0074
OG0086
OG0096
OG0104
OG0115
OG0121
OG0130
OG0140
OG0152
OG0161
OG0172
OG0183
OG0193
OG0202
OG0215
OG0225
OG0233
OG0240
OG0251
OG0261
OG0273
OG0283
OG0293
OG0303
OG0316
OG0324
OG0336
OG0348
OG0359
Easy to swallow tablet
OG0002
OG0011
OG0022
OG0033
OG004
Neither easy nor difficult to swallow tablet
OG0000
OG0010
OG0020
OG0030
OG004
Difficult to swallow tablet
OG0000
OG0010
OG0020
OG0030
OG004
Very difficult to swallow tablet
OG0000
OG0010
OG0020
OG0030
OG004
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
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0 events
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9 at risk
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0 events
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0 events
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0 events
0 affected
9 at risk
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9 events
2 affected
9 at risk
EG0045 events2 affected3 at risk
EG00520 events8 affected11 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0056 events4 affected11 at risk
EG0060 events0 affected1 at risk
17 events
6 affected
9 at risk
EG00415 events3 affected3 at risk
EG00537 events8 affected11 at risk
EG0067 events1 affected1 at risk
8 events
4 affected
9 at risk
EG0048 events2 affected3 at risk
EG00520 events9 affected11 at risk
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0 events
0 affected
9 at risk
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1 events
1 affected
9 at risk
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0 events
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1 events
1 affected
9 at risk
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2 affected
9 at risk
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0 events
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22 events
5 affected
9 at risk
EG0046 events3 affected3 at risk
EG00526 events9 affected11 at risk
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1 events
1 affected
9 at risk
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4 events
2 affected
9 at risk
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EG0057 events4 affected11 at risk
EG0069 events1 affected1 at risk
0 events
0 affected
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1 events
1 affected
9 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
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12 events
6 affected
9 at risk
EG0043 events2 affected3 at risk
EG00516 events6 affected11 at risk
EG0069 events1 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
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3 events
2 affected
9 at risk
EG0040 events0 affected3 at risk
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1 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected11 at risk
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1 events
1 affected
9 at risk
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2 events
1 affected
9 at risk
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1 events
1 affected
9 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
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2 events
2 affected
9 at risk
EG0040 events0 affected3 at risk
EG0058 events4 affected11 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
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0 events
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9 at risk
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0 events
0 affected
9 at risk
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0 events
0 affected
9 at risk
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0 affected
9 at risk
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0 events
0 affected
9 at risk
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0 events
0 affected
9 at risk
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0 affected
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1 affected
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0 events
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0 affected
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0 events
0 affected
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0 events
0 affected
4 at risk
EG0040 events0 affected3 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
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1 events
1 affected
9 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
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2 events
1 affected
9 at risk
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1 events
1 affected
9 at risk
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0 events
0 affected
9 at risk
EG0043 events2 affected3 at risk
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0 events
0 affected
9 at risk
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0 events
0 affected
9 at risk
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0 events
0 affected
9 at risk
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5 events
2 affected
9 at risk
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0 events
0 affected
9 at risk
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0 events
0 affected
9 at risk
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0 affected
9 at risk
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0 events
0 affected
9 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
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2 events
1 affected
9 at risk
EG0043 events2 affected3 at risk
EG0055 events3 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
2 events
2 affected
9 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected1 at risk
0 events
0 affected
9 at risk
EG0042 events1 affected3 at risk
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0 events
0 affected
9 at risk
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0 events
0 affected
9 at risk
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0 events
0 affected
9 at risk
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0 events
0 affected
9 at risk
EG0041 events1 affected3 at risk
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0 events
0 affected
9 at risk
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0 events
0 affected
9 at risk
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0 events
0 affected
9 at risk
EG0041 events1 affected3 at risk
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EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0041 events1 affected3 at risk
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EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
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EG0061 events1 affected1 at risk
2 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0044 events2 affected3 at risk
EG0051 events1 affected11 at risk
EG0061 events1 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
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0 events
0 affected
9 at risk
EG0042 events2 affected3 at risk
EG0053 events3 affected11 at risk
EG0061 events1 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected11 at risk
EG0060 events0 affected1 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected11 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
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EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected11 at risk
EG0060 events0 affected1 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected1 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
5 events
2 affected
9 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0055 events2 affected11 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected11 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
2 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected1 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected1 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
1 events
1 affected
9 at risk
EG0041 events1 affected3 at risk
EG0053 events2 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected11 at risk
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1 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected1 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
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0 events
0 affected
9 at risk
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0 events
0 affected
9 at risk
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1 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
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1 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
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1 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected11 at risk
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0 events
0 affected
9 at risk
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EG0050 events0 affected11 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
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0 events
0 affected
9 at risk
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0 events
0 affected
9 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
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1 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected1 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected11 at risk
EG0061 events1 affected1 at risk
1 events
1 affected
9 at risk
EG0043 events2 affected3 at risk
EG0052 events2 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected11 at risk
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0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected1 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected11 at risk
EG0060 events0 affected1 at risk
1 events
1 affected
9 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected11 at risk
EG0063 events1 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
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EG0060 events0 affected1 at risk
0 events
0 affected
9 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected1 at risk
757
± 100
NA
± NA
Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there were only two participants. Individual values reported: 994.32 ng\*h/mL and 2247.03 ng\*h/mL.