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| ID | Type | Description | Link |
|---|---|---|---|
| J1S-MC-JP04 | Other Identifier | Eli Lilly and Company | |
| 2023-506772-28-00 | EU Trial (CTIS) Number | ||
| 2021-004734-11 | EudraCT Number | ||
| U1111-1302-8098 | Other Identifier | WHO Universal Trial Number |
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The purpose of this study is to measure the benefit of adding abemaciclib to chemotherapy (irinotecan and temozolomide) for Ewing's sarcoma that has come back or did not respond to treatment. This trial is part of the CAMPFIRE master protocol, which is a platform to speed development of new treatments for children and young adults with cancer. Your participation in this trial could last 11 months or longer, depending on how you and your tumor respond.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abemaciclib + Irinotecan +Temozolomide | Experimental | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.
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| Irinotecan +Temozolomide | Experimental | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abemaciclib | Drug | Orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Assessed by Blinded Independent Review Committee (BIRC) by Bayesian Analysis | PFS was defined as the time from randomization until the first occurrence of documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause in absence of progressive disease, whichever came first. Progressive disease (PD) was defined as at least 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions. An event was considered when tumor progression or death occurred, with event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at date of their last adequate tumor assessment per RECIST v1.1 criteria, or date of randomization (whichever was later). Results were obtained using Bayesian analysis and are reported as posterior mean along with its 80% credible interval. | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months) |
| PFS Assessed by BIRC by Frequentist Analysis | PFS was defined as the time from randomization until the first occurrence of documented disease progression per RECIST v1.1 criteria, or death from any cause in absence of progressive disease, whichever came first. PD was defined as at least 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. An event was considered when tumor progression or death occurred, with the event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at the date of their last adequate tumor assessment per RECIST v1.1 criteria, or date of randomization (whichever was later). Results were obtained using frequentist analysis. | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months) |
| Measure | Description | Time Frame |
|---|---|---|
| PFS Assessed by Investigator by Bayesian Analysis | PFS was defined as the time from randomization until the first occurrence of documented disease progression per RECIST v1.1 criteria, or death from any cause in absence of progressive disease, whichever came first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. An event was considered when tumor progression or death occurred, with the event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at the date of their last adequate tumor assessment per RECIST v1.1 criteria, or date of randomization (whichever was later). Results were obtained using Bayesian analysis and are reported as posterior mean along with its 80% credible interval. |
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Inclusion Criteria:
Diagnosis of Ewing's sarcoma or Ewing's sarcoma-like tumor by institutional pathologist. The original pathological report is required. Repeat biopsy at progression is not required
Refractory disease or confirmed radiological progression or recurrence following first or later line of treatment of Ewing's sarcoma or Ewing's sarcoma-like tumor
-- Must have one measurable or evaluable lesion per RECIST 1.1
Adequate performance status based on age
Participants must have discontinued all previous treatments for cancer or investigational agents ≥7 days after the last dose and must have recovered from the acute effects
Adequate hematologic and organ function less than or equal to (≤)14 days prior to Day 1 of Cycle 1:
Female participants of childbearing potential must have a negative urine or serum pregnancy test
Body weight ≥10 kilograms (kg)
Must be able to swallow and/or have a gastric/nasogastric tube
-- Participants in the European Union must be able to swallow intact capsules
Stable or decreasing dose of steroids at least 7 days prior to enrollment
Life expectancy of at least 8 weeks and able to complete at least 1 cycle of treatment
Participants/caregivers are able and willing to make themselves available for the duration of the study and are willing to follow study procedures, including adherence to the pharmacokinetic (PK) sampling schedule
Exclusion Criteria:
Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
Participants with an active fungal, bacterial, and/or known severe viral infection including, but not limited to, human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis.
Participants who have had allogeneic bone marrow or solid organ transplant
Surgery: Participants who have had, or are planning to have, the following invasive procedures:
Female participants who are pregnant or breastfeeding
Have received any prior cyclin-dependent kinase (CDK) 4 and 6 inhibitor
Progression during prior treatment with irinotecan and/or temozolomide
Have a known intolerability or hypersensitivity to any of the study treatments or dacarbazine
Diagnosed and/or treated additional malignancy within 3 years prior to enrollment
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| 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) |
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| Label | URL |
|---|---|
| CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma (CAMPFIRE) | View source |
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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.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Abemaciclib + Irinotecan +Temozolomide | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 3, 2023 | Jan 14, 2026 |
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| Irinotecan | Drug | IV |
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| Temozolomide | Drug | Orally |
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| From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.39 Months) |
| PFS Assessed by Investigator by Frequentist Analysis | PFS was defined as the time from randomization until the first occurrence of documented disease progression per RECIST v1.1 criteria, or death from any cause in absence of progressive disease, whichever came first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. An event was considered when tumor progression or death occurred, with the event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever was later). Results were obtained using frequentist analysis. | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.39 Months) |
| Overall Survival (OS) | OS was defined as the time from date of randomization until death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data were censored on the last date the participant was known to be alive. | From Date of Randomization until Death Due to Any Cause (Up to 26.37 months) |
| Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) Assessed by BIRC | ORR was defined as the number of participants who achieved the best overall response of complete response (CR) or partial response (PR) as per RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. | From Date of Randomization until Disease Progression, Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.36 Months) |
| ORR: Percentage of Participants Who Achieved a CR or PR Assessed by Investigator | ORR was defined as the number of participants who achieved the best overall response of CR or PR as per RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. | From Date of Randomization until Disease Progression, Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.39 Months) |
| Duration of Response (DoR) Assessed by BIRC | DoR was defined as the time from the date that measurement criteria for CR or PR (whichever was first recorded) were first met until the first date that recurrent disease or documented disease progression was observed per RECIST v1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence. DoR was calculated for participants with only PR or CR. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Participants with an observed CR or PR, no confirmed disease progression per RECIST v1.1 criteria, and no death due to any cause were censored at the time of the last adequate post-baseline scan. | From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up to 10.7 Months) |
| DoR Assessed by Investigator | DoR was defined as the time from the date that measurement criteria for CR or PR (whichever was first recorded) were first met until the first date that recurrent disease or documented disease progression was observed, per RECIST v1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence. DoR was calculated for participants with only PR or CR. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Participants with an observed CR or PR, no confirmed disease progression per RECIST v1.1 criteria, and no death due to any cause were censored at the time of the last adequate post-baseline scan. | From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up to 12.7 Months) |
| Percentage of Participants With a Best Overall Response of CR, PR, Stable Disease (SD) or Non-CR/Non-PD: Disease Control Rate (DCR) Assessed by BIRC | Disease control rate (DCR) was the percentage of participants with a best overall response of CR, PR, SD or Non-CR/Non-PD as defined by RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Non-CR/Non-PD was defined as persistence of one or more non-target lesions and/or maintained tumor marker levels, but without sufficient progression to be considered PD and without complete disappearance to be CR. | From Date of Randomization until Disease Progression, or Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.36 Months) |
| Percentage of Participants With a Best Overall Response of CR, PR or SD: DCR Assessed by Investigator | DCR was the percentage of participants with a best overall response of CR, PR, or SD as defined by RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease for target lesions, no progression of non-target lesions, and no appearance of new lesions. | From Date of Randomization until Disease Progression, or Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.39 Months) |
| Pharmacokinetics (PK): Minimum Plasma Concentration (Cmin) of Abemaciclib | PK: Cmin of Abemaciclib were reported. | Pre-dose on Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1; End of irinotecan infusion on Cycle 2 Day 1 and Cycle 4 Day 1 |
| Abemaciclib Product Acceptability | Participants were evaluated for abemaciclib acceptability by asking a question - " Was it easy or difficult for the study participant 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". Acceptability was assessed for formulations: tablets, oral granules, and dispersed tablets. | Day 1 of Cycle 1 through Cycle 3 (21-day cycles) |
| Los Angeles |
| California |
| 90095-1752 |
| United States |
| Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana | 46202 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Lifespan Cancer Institute | Providence | Rhode Island | 02906 | United States |
| The Children's Hospital at Westmead | Westmead | New South Wales | 2145 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Royal Children's Hospital | Melbourne | Victoria | 3052 | Australia |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest | Bordeaux | Aquitaine | 33076 | France |
| Centre Leon Berard | Lyon | Auvergne-Rhône-Alpes | 69373 CEDEX 08 | France |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Universitätsklinikum Essen | Essen | North Rhine-Westphalia | 45122 | Germany |
| Charité Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Fondazione Policlinico Universitario Agostino Gemelli | Rome | Lazio | 00168 | Italy |
| IRCCS Istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
| Hyogo Prefectural Kobe Children's Hospital | Kobe | Hyōgo | 650-0047 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Hospital Sant Joan de Déu | Esplugues de Llobregat | Barcelona [Barcelona] | 08950 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Catalunya [Cataluña] | 08041 | Spain |
| Hospital Infantil Universitario Niño Jesús | Madrid | Madrid, Comunidad de | 28009 | Spain |
| Hospital Universitario La Paz | Madrid | Madrid, Comunidad de | 28046 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28009 | Spain |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| FG001 | Irinotecan +Temozolomide | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.
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| Received at Least One Dose of Study Drug |
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| COMPLETED | Completers included participants who received at least one dose of study drug and died due to any cause. |
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| NOT COMPLETED |
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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Abemaciclib + Irinotecan +Temozolomide | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.
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| BG001 | Irinotecan +Temozolomide | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.
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| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression Free Survival (PFS) Assessed by Blinded Independent Review Committee (BIRC) by Bayesian Analysis | PFS was defined as the time from randomization until the first occurrence of documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause in absence of progressive disease, whichever came first. Progressive disease (PD) was defined as at least 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions. An event was considered when tumor progression or death occurred, with event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at date of their last adequate tumor assessment per RECIST v1.1 criteria, or date of randomization (whichever was later). Results were obtained using Bayesian analysis and are reported as posterior mean along with its 80% credible interval. | All randomized participants (including the censored participants). Number of participants censored in Abemaciclib + Irinotecan +Temozolomide =8, Irinotecan +Temozolomide = 3. | Posted | Mean | 80% Confidence Interval | Months | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months) |
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| Primary | PFS Assessed by BIRC by Frequentist Analysis | PFS was defined as the time from randomization until the first occurrence of documented disease progression per RECIST v1.1 criteria, or death from any cause in absence of progressive disease, whichever came first. PD was defined as at least 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. An event was considered when tumor progression or death occurred, with the event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at the date of their last adequate tumor assessment per RECIST v1.1 criteria, or date of randomization (whichever was later). Results were obtained using frequentist analysis. | All randomized participants (including the censored participants). Number of participants censored in Abemaciclib + Irinotecan +Temozolomide =8, Irinotecan +Temozolomide = 3. | Posted | Median | 95% Confidence Interval | Months | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months) |
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| Secondary | PFS Assessed by Investigator by Bayesian Analysis | PFS was defined as the time from randomization until the first occurrence of documented disease progression per RECIST v1.1 criteria, or death from any cause in absence of progressive disease, whichever came first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. An event was considered when tumor progression or death occurred, with the event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at the date of their last adequate tumor assessment per RECIST v1.1 criteria, or date of randomization (whichever was later). Results were obtained using Bayesian analysis and are reported as posterior mean along with its 80% credible interval. | All randomized participants (including the censored participants). Number of participants censored in Abemaciclib + Irinotecan +Temozolomide =6, Irinotecan +Temozolomide = 3. | Posted | Mean | 80% Confidence Interval | Months | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.39 Months) |
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| Secondary | PFS Assessed by Investigator by Frequentist Analysis | PFS was defined as the time from randomization until the first occurrence of documented disease progression per RECIST v1.1 criteria, or death from any cause in absence of progressive disease, whichever came first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. An event was considered when tumor progression or death occurred, with the event date being the earliest date of PD or death. Participants known to be alive and without tumor progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever was later). Results were obtained using frequentist analysis. | All randomized participants (including the censored participants). Number of participants censored in Abemaciclib + Irinotecan +Temozolomide =6, Irinotecan +Temozolomide = 3. | Posted | Median | 95% Confidence Interval | Months | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.39 Months) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from date of randomization until death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data were censored on the last date the participant was known to be alive. | All randomized participants (including the censored participants). Number of participants censored in Abemaciclib + Irinotecan +Temozolomide = 15, Irinotecan +Temozolomide = 7. | Posted | Median | 95% Confidence Interval | Months | From Date of Randomization until Death Due to Any Cause (Up to 26.37 months) |
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| Secondary | Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) Assessed by BIRC | ORR was defined as the number of participants who achieved the best overall response of complete response (CR) or partial response (PR) as per RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. | All randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Date of Randomization until Disease Progression, Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.36 Months) |
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| Secondary | ORR: Percentage of Participants Who Achieved a CR or PR Assessed by Investigator | ORR was defined as the number of participants who achieved the best overall response of CR or PR as per RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. | All randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Date of Randomization until Disease Progression, Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.39 Months) |
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| Secondary | Duration of Response (DoR) Assessed by BIRC | DoR was defined as the time from the date that measurement criteria for CR or PR (whichever was first recorded) were first met until the first date that recurrent disease or documented disease progression was observed per RECIST v1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence. DoR was calculated for participants with only PR or CR. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Participants with an observed CR or PR, no confirmed disease progression per RECIST v1.1 criteria, and no death due to any cause were censored at the time of the last adequate post-baseline scan. | All randomized participants who received at least one dose of study drug and who had CR or PR responses (including the censored participants). Number of participants censored in Abemaciclib + Irinotecan +Temozolomide =1, Irinotecan +Temozolomide = 3. | Posted | Median | 95% Confidence Interval | Months | From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up to 10.7 Months) |
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| Secondary | DoR Assessed by Investigator | DoR was defined as the time from the date that measurement criteria for CR or PR (whichever was first recorded) were first met until the first date that recurrent disease or documented disease progression was observed, per RECIST v1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence. DoR was calculated for participants with only PR or CR. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Participants with an observed CR or PR, no confirmed disease progression per RECIST v1.1 criteria, and no death due to any cause were censored at the time of the last adequate post-baseline scan. | All randomized participants who received at least one dose of study drug and who had CR or PR responses (including the censored participants). Number of participants censored in Abemaciclib + Irinotecan +Temozolomide =2, Irinotecan +Temozolomide = 1. | Posted | Median | 95% Confidence Interval | Months | From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up to 12.7 Months) |
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| Secondary | Percentage of Participants With a Best Overall Response of CR, PR, Stable Disease (SD) or Non-CR/Non-PD: Disease Control Rate (DCR) Assessed by BIRC | Disease control rate (DCR) was the percentage of participants with a best overall response of CR, PR, SD or Non-CR/Non-PD as defined by RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Non-CR/Non-PD was defined as persistence of one or more non-target lesions and/or maintained tumor marker levels, but without sufficient progression to be considered PD and without complete disappearance to be CR. | All randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Date of Randomization until Disease Progression, or Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.36 Months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Best Overall Response of CR, PR or SD: DCR Assessed by Investigator | DCR was the percentage of participants with a best overall response of CR, PR, or SD as defined by RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease for target lesions, no progression of non-target lesions, and no appearance of new lesions. | All randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Date of Randomization until Disease Progression, or Death Due to Any Cause, Concomitant Radiotherapy/Surgery, or Start of New Anti-Cancer Therapy (Up to 22.39 Months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Minimum Plasma Concentration (Cmin) of Abemaciclib | PK: Cmin of Abemaciclib were reported. | All randomized participants who received at least one dose of abemaciclib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | Pre-dose on Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1; End of irinotecan infusion on Cycle 2 Day 1 and Cycle 4 Day 1 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Abemaciclib Product Acceptability | Participants were evaluated for abemaciclib acceptability by asking a question - " Was it easy or difficult for the study participant 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". Acceptability was assessed for formulations: tablets, oral granules, and dispersed tablets. | All randomized participants 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 2 Day 1, and Cycle 3 Day 1. Here, 'Number Analyzed' refers to the number of participants or caregivers who provided responses. | Posted | Count of Participants | Participants | No | Day 1 of Cycle 1 through Cycle 3 (21-day cycles) |
|
Baseline up to end of follow-up (up to 26.37 months)
All-Cause Mortality: All randomized participants. Serious and other adverse events: All randomized participants who received at least one dose of study drug; Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abemaciclib + Irinotecan +Temozolomide | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.
| 15 | 30 | 12 | 30 | 30 | 30 |
| EG001 | Irinotecan +Temozolomide | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.
| 8 | 16 | 5 | 15 | 15 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Herpes zoster reactivation | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Visual field defect | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anal rash | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Catheter site thrombosis | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Feeling of body temperature change | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Medical device site inflammation | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mucosal dryness | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Puncture site pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoglossal nerve disorder | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mixed anxiety and depressive disorder | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Self-destructive behaviour | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Urethral haemorrhage | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intermenstrual bleeding | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Photodermatosis | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Central venous catheterisation | Surgical and medical procedures | MedDRA 27.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
The Bayesian models for PFS by BIRC and PFS by Investigator assume an exponential distribution for the PFS times, which is more restrictive than the distributional assumptions made by the frequentist Cox proportional hazards model.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 23, 2022 | Jan 14, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012512 | Sarcoma, Ewing |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000590451 | abemaciclib |
| D000077146 | Irinotecan |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Japan |
|
| Italy |
|
| France |
|
| Australia |
|
| Germany |
|
| Spain |
|
| OG001 | Irinotecan +Temozolomide | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.
|
|
|
|
| OG001 | Irinotecan +Temozolomide | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.
|
|
|
|
| OG001 | Irinotecan +Temozolomide | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.
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| OG001 | Irinotecan +Temozolomide | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.
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| OG001 | Irinotecan +Temozolomide | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.
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| OG001 | Irinotecan +Temozolomide | Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.
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Participants received the following treatments in a 21-day cycle, continuing until disease progression, unacceptable toxicity, or a criterion for discontinuation was met.
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| OG002 | Abemaciclib (Cycle 3 Day 1) | Participants received 55 mg/m² abemaciclib administered orally BID for <18 years or 100 mg administered orally BID for ≥18 years on Day 1 Cycle 3 were reported in this arm. |
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| Easy to swallow |
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| Neither easy nor difficult to swallow |
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| Difficult to swallow |
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| Very difficult to swallow |
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| Easy to swallow |
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| Neither easy nor difficult to swallow |
|
| Difficult to swallow |
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| Very difficult to swallow |
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| Easy to swallow |
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| Neither easy nor difficult to swallow |
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| Difficult to swallow |
|
| Very difficult to swallow |
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| Difficult to swallow |
| Very difficult to swallow |
| Easy to swallow |
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| Neither easy nor difficult to swallow |
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| Difficult to swallow |
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| Very difficult to swallow |
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