Trial · NCT05440786
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) Assessed by Blinded Independent Review Committee (BIRC) by Bayesian Analysis | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months) | 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. |
| Primary | PFS Assessed by BIRC by Frequentist Analysis | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.36 months) | 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. |
| Secondary | PFS Assessed by Investigator by Bayesian Analysis | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.39 Months) | 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. |
| Secondary | PFS Assessed by Investigator by Frequentist Analysis | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up to 22.39 Months) | 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. |
| Secondary | Overall Survival (OS) | From Date of Randomization until Death Due to Any Cause (Up to 26.37 months) | 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. |
| Secondary | Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) Assessed by BIRC | 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 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. |
| Secondary | ORR: Percentage of Participants Who Achieved a CR or PR Assessed by Investigator | 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) | 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. |
| Secondary | Duration of Response (DoR) Assessed by BIRC | From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up to 10.7 Months) | 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. |
| Secondary | DoR Assessed by Investigator | From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up to 12.7 Months) | 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. |
| 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 | 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) | 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. |
| Secondary | Percentage of Participants With a Best Overall Response of CR, PR or SD: DCR Assessed by Investigator | 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) | 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. |
| Secondary | Pharmacokinetics (PK): Minimum Plasma Concentration (Cmin) of Abemaciclib | 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 | PK: Cmin of Abemaciclib were reported. |
| Secondary | Abemaciclib Product Acceptability | Day 1 of Cycle 1 through Cycle 3 (21-day cycles) | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT05440786/registered