The prognosis of patients with recurrent, late-stage inoperable, or progressed biliary tract carcinoma (BTC) is generally poor. The goal of this clinical study is to determine the effectiveness and safety of abemaciclib in patients with late-stage or progressed BTC that has failed one line of chemotherapy.
Biliary Tract Carcinoma (BTC) is a leading cause of cancer-related mortality. The newly developed small molecule inhibitor of cyclin-dependent kinases (CDK4 and CDK6), abemaciclib, provides a new opportunity of treating patients with BTC. The goal of this clinical study is to determine the efficacy and safety of abemaciclib in patients with advanced or metastatic BTC that has progressed or intolerant to one or more lines of systemic therapy, or treatment-naïve subjects who either decline or being considered not a good candidate first-line systemic chemotherapy per the opinion of the treating physician. The investigator's objectives for this study are as follows: Primary Objectives: • To estimate the objective response rate (ORR) Secondary Objectives: * To determine progression free survival (PFS) * To determine the disease control rate (DCR) * To determine the overall survival (OS) rate at 6 and 12 months * To determine quality of life (QoL) using EORTC-QLQ-C30
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Participant will take 200 mg capsules or tablets orally twice daily. The participant will be instructed to swallow abemaciclib as a whole tablet and not to chew, crush or split capsules or tablets before swallowing. Participants should not ingest abemaciclib tablets if broken, cracked, or otherwise not intact. Doses should be taken at a approximately the same time every day, twice daily. Capsules or tablets can be taken orally with or without food. If the participant vomits or misses a dose of abemaciclib, the participant will be instructed to take the next dose at its scheduled time. Participants will also be provided with a diary and instructed to keep a twice daily record of the times they have taken their medications and any other events such as vomiting, diarrhea, etc.
Penn State Cancer Institute
Hershey, Pennsylvania, United States
Overall Response Rate
overall response rate (ORR) is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.The scale of ORR ranges from 0% to 100%, where 0% indicates no subjects achieved CR or PR, and 100% indicates all evaluable subjects achieved CR or PR.
Time frame: no longer than 7 months
Progression-free Survival
the time interval from date of first dose of study drug to first documented disease progression or death from any cause, whichever occurs first. The PFS scale ranges from 0 days (for immediate progression or death) to the longest observed duration without progression or death.
Time frame: through study completion, an average of 2 years
Disease Control Rate
Disease Control Rate (DCR) is defined as the proportion of subjects who achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. The scale of DCR ranges from 0% to 100%, where 0% indicates no subjects achieved CR, PR, or SD, and 100% indicates all evaluable subjects achieved disease control (CR, PR, or SD). Subjects who do not have sufficient data to determine response status are excluded from the denominator.
Time frame: no longer than 7 months
Overall Survival Rate
Overall survival rate (OSR) is is typically reported as a percentage (%), representing the proportion of subjects who are alive at a specific time point after receiving the first dose of the study drug. The scale of Overall Survival Rate (OSR) ranges from 0% to 100%, where 0% indicates that none of the study participants survived for the specified period after the first dose of the study drug, and 100% indicates that all participants are alive at that time point. A higher OSR percentage suggests a greater proportion of subjects who have survived, reflecting the potential effectiveness of the treatment under investigation.
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Time frame: up to 6 months
Overall Survival Rate
Overall survival rate (OSR) is is typically reported as a percentage (%), representing the proportion of subjects who are alive at a specific time point after receiving the first dose of the study drug. The scale of Overall Survival Rate (OSR) ranges from 0% to 100%, where 0% indicates that none of the study participants survived for the specified period after the first dose of the study drug, and 100% indicates that all participants are alive at that time point. A higher OSR percentage suggests a greater proportion of subjects who have survived, reflecting the potential effectiveness of the treatment under investigation. Overall Survival at 12 months is not available. Data were only collected up to 6 months.
Time frame: up to 12 months
Quality of Life Score
Quality of Life (QoL) will be assessed from the date of baseline and then every 4 weeks using the EORTC QLQ-C30. The QLQ-C30 comprises both multi-item scales and single-item measures, including a global health status/QoL scale, five functional scales, three multi-item symptom scales, and six single-item scales. For the multi-item scales, the raw score (RS) is calculated by taking the mean of the individual item scores. A linear transformation is then applied to standardize the raw score, resulting in a standardized score ranging from 0 to 100, where a score of 0 indicates the worst possible QoL and a score of 100 indicates the best possible QoL.
Time frame: Prior to treatment with Abemaciclib (baseline)
Quality of Life Score
Quality of Life (QoL) will be assessed from the date of baseline and then every 4 weeks using the EORTC QLQ-C30. The QLQ-C30 comprises both multi-item scales and single-item measures, including a global health status/QoL scale, five functional scales, three multi-item symptom scales, and six single-item scales. For the multi-item scales, the raw score (RS) is calculated by taking the mean of the individual item scores. A linear transformation is then applied to standardize the raw score, resulting in a standardized score ranging from 0 to 100, where a score of 0 indicates the worst possible QoL and a score of 100 indicates the best possible QoL.
Time frame: Cycle 1 (28 days) treatment with Abemaciclib
Quality of Life Score
Quality of Life (QoL) will be assessed from the date of baseline and then every 4 weeks using the EORTC QLQ-C30. The QLQ-C30 comprises both multi-item scales and single-item measures, including a global health status/QoL scale, five functional scales, three multi-item symptom scales, and six single-item scales. For the multi-item scales, the raw score (RS) is calculated by taking the mean of the individual item scores. A linear transformation is then applied to standardize the raw score, resulting in a standardized score ranging from 0 to 100, where a score of 0 indicates the worst possible QoL and a score of 100 indicates the best possible QoL.
Time frame: Cycle 2 (56 days) treatment with Abemaciclib
Quality of Life Score
Quality of Life (QoL) will be assessed from the date of baseline and then every 4 weeks using the EORTC QLQ-C30. The QLQ-C30 comprises both multi-item scales and single-item measures, including a global health status/QoL scale, five functional scales, three multi-item symptom scales, and six single-item scales. For the multi-item scales, the raw score (RS) is calculated by taking the mean of the individual item scores. A linear transformation is then applied to standardize the raw score, resulting in a standardized score ranging from 0 to 100, where a score of 0 indicates the worst possible QoL and a score of 100 indicates the best possible QoL.
Time frame: Assessment at the end of treatment with Abemaciclib, approximately 60 days after starting treatment.