Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03891784|
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : July 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Digestive System Neuroendocrine Neoplasm Digestive System Neuroendocrine Tumor Foregut Carcinoid Tumor Hindgut Carcinoid Tumor Locally Advanced Unresectable Digestive System Neuroendocrine Neoplasm Metastatic Digestive System Neuroendocrine Neoplasm Midgut Carcinoid Tumor Pancreatic Neuroendocrine Tumor Refractory Digestive System Neuroendocrine Neoplasm||Drug: Abemaciclib||Phase 2|
Patients receive abemaciclib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 4 months for up to 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Trial of the CDK4/6 Inhibitor Abemaciclib in Patients With Advanced and Refractory Well-Differentiated Gastroenteropancreatic Neuroendocrine Tumors (GEP NETs)|
|Estimated Study Start Date :||August 15, 2019|
|Estimated Primary Completion Date :||September 30, 2023|
|Estimated Study Completion Date :||September 30, 2024|
Experimental: Treatment (abemaciclib)
Patients receive abemaciclib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Objective response rate (ORR) [ Time Frame: Up to 1 year ]ORR defined as complete or partial response as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, will be represented by a waterfall plot.
- Progression-free survival [ Time Frame: From study registration to radiographic progression per RECIST v1.1 (investigator assessment), clinical progression, or death of any cause, assessed up to 1 year ]The distribution for survival times will be estimated using the method of Kaplan-Meier; associated landmark time percentages and the median value will be based on this. Confidence intervals for median values will use the Brookmeyer-Crowley method. Survival outcomes between carcinoid tumors and pancreatic neuroendocrine tumor (PNET)s will be compared using a log-rank test.
- Overall survival [ Time Frame: Time from study registration to death of any cause, assessed up to 1 year ]The distribution for survival times will be estimated using the method of Kaplan-Meier; associated landmark time percentages and the median value will be based on this. Confidence intervals for median values will use the Brookmeyer-Crowley method. Survival outcomes between carcinoid tumors and PNETs will be compared using a log-rank test.
- Incidence of adverse events [ Time Frame: Up to 30 days ]Safety will be evaluated by assessing the adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.
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): NCT03891784
|Contact: Kaylyn Kit Man Wongfirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado||Not yet recruiting|
|Denver, Colorado, United States, 80217|
|Contact: Stephen Leong 303-724-3837|
|Principal Investigator: Stephen Leong|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Not yet recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Kaylyn Kit Man Wong 206-606-2038 email@example.com|
|Principal Investigator: Kaylyn Kit Man Wong|
|Principal Investigator:||Kaylyn Kit Man Wong||Fred Hutch/University of Washington Cancer Consortium|