A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma Who Failed Prior First Line Therapy
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|ClinicalTrials.gov Identifier: NCT04003896|
Recruitment Status : Not yet recruiting
First Posted : July 1, 2019
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Biliary Tract Carcinoma||Drug: Abemaciclib||Phase 2|
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 following one line of chemotherapy.
The investigator's objectives for this study are as follows:
• To determine the objective response rate (ORR)
- 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 (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a Phase 2 open label study to determine the efficacy and safety/tolerability of abemaciclib in participants with locally advanced, unresectable, or metastatic biliary tract cancer who have failed (tumor progression or patient intolerance) one or more lines of systemic therapy. A Simon's two-stage design will be used. If there are no responses in the first 13 patients with a determined outcome, the study will be stopped. Otherwise, 11 additional patients will be accrued for a total of 24. Abemaciclib will be given as a single oral agent Approximately up to 27 subjects may be enrolled to attain at least 24 evaluable participants. The starting dose will be 200 mg twice daily. Dosing will continue daily for 28 days, this being one cycle. There will be no protocol scheduled hiatus and daily dosing will be continuous unless there is unacceptable toxicity, disease progression, or death.|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study to Evaluate the Response and Tolerability of Verzenio (Abemaciclib) in Patients With Advanced Biliary Tract Carcinoma Who Have Failed Prior Chemotherapy|
|Estimated Study Start Date :||October 31, 2020|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
Abemaciclib will be given as a single oral agent Approximately up to 27 subjects may be enrolled to attain at least 24 evaluable participants. The starting dose will be 200 mg twice daily. Dosing will continue daily for 28 days, this being one cycle. There will be no protocol scheduled hiatus and daily dosing will be continuous unless there is unacceptable toxicity, disease progression, or death.
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.
Other Name: Verzenio
- overall response rate [ Time Frame: approximately 7 months ]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 at the beginning of cycle 3, 5, 7 (each cycle is 28 days).
- Progression-free survival [ Time Frame: 3 years ]the time interval from date of first dose of study drug to first documented disease progression or death from any cause, whichever occurs first.
- disease control rate [ Time Frame: approximately 7 months ]tThe number of subjects achieving a response (complete response, partial response, stable disease) at the beginning of cycle 3, 5, 7 (each cycle is 28 days).
- overall survival rate [ Time Frame: up to 12 months ]the proportion of subjects who are alive at 6 months and 12 months from the date of first dose of study drug, respectively.
- quality of life questionaire [ Time Frame: approximately 8 months ]from the date of baseline and then every 4 weeks using the EORTC-QLQ-C30 at the end of cycle 1,2,3,4,5,6,7,8 (each cycle is 28 days).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003896
|Contact: Clinical Research Coordinator RN Penn State Cancer Institute||717 531 5471||PSCI-CTO@pennstatehealth.psu.edu|
|Contact: Nelson Yee, MD, Ph.D||7175310003 ext email@example.com|
|United States, Pennsylvania|
|Penn State Cancer Institute|
|Hershey, Pennsylvania, United States, 17033-0850|
|Contact: Nelson Yee, MD, Ph.D 717-531-0003 ext 280677 firstname.lastname@example.org|
|Principal Investigator:||Nelson Yee, MD, Ph.D||Penn State Cancer Institute|