Ribociclib in Treating Patients With Advanced Neuroendocrine Tumors of Foregut Origin
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02420691|
Recruitment Status : Completed
First Posted : April 20, 2015
Results First Posted : October 30, 2020
Last Update Posted : October 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Digestive System Neuroendocrine Neoplasm Duodenal Neuroendocrine Tumor G1 Functional Pancreatic Neuroendocrine Tumor Gastric Neuroendocrine Tumor Intermediate Grade Lung Neuroendocrine Neoplasm Low Grade Lung Neuroendocrine Neoplasm Nonfunctional Pancreatic Neuroendocrine Tumor Thymus Neoplasm||Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Ribociclib||Phase 2|
I. To estimate the Response Evaluation Criteria in Solid Tumors (RECIST) (per version 1.1) objective response rate of LEE011 (ribociclib) among patients with advanced foregut neuroendocrine tumors (NETs).
I. To evaluate the progression free survival duration of LEE011 among patients with advanced foregut NETs.
II. To evaluate the safety and tolerability of LEE011 in patients with advanced foregut NETs.
III. To determine clinic benefit rate at 6 months (defined as complete response plus partial response plus stable disease) with LEE011 among patients with advanced foregut NETs.
I. To determine baseline molecular markers (mutations, deletions, and amplifications in multiple endocrine neoplasia [MEN]1, p27, p16 and cyclin D1 [CCND1]) in archival tumor that may predict clinical benefit at 6 months from LEE011.
II. To determine potential mechanisms/markers of resistance. III. To determine early chromogranin and neuron specific enolase responses in patients with elevated levels at baseline.
IV. To determine the pharmacodynamic changes including proliferation-related Ki-67 antigen (Ki-67) and phosphorylated retinoblastoma (pRb) upon treatment with LEE011 in patients with advanced foregut NETs.
Patients receive ribociclib orally (PO) once daily (QD) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of LEE011 (Ribociclib) in Patients With Advanced Neuroendocrine Tumors of Foregut Origin|
|Actual Study Start Date :||August 25, 2015|
|Actual Primary Completion Date :||June 5, 2019|
|Actual Study Completion Date :||June 5, 2019|
Experimental: Treatment (ribociclib)
Patients receive ribociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Number of Participants With Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 [ Time Frame: 3 years 10 months ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Number of Participants With Clinical Benefit Rate [ Time Frame: At 6 months ]Number of Participants that did not have progressive disease at 6 months.
- Progression Free Survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 24 months ]PFS is the length of time during and after the treatment that a participant lives with the disease but it does not get worse.The Kaplan-Meier (KM) method will be used to estimate the PFS.
- Change in pRB With Treatment [ Time Frame: Baseline (Pre-Treatment) and Cycle 2 Day 1, each Cycle is 28 days ]Decrease in pRB as Measured by Immunohistochemistry (IHC) in Biopsies From Baseline and From cycle 2 day 1. H-scores were calculated as the sum of the products of the percentage of positive staining areas and the staining intensity (0, 1, 2 or 3), and ranged from 0 to 300. A score of 0 represents the absence of expression, and an H-score of 300 represents maximum expression.
- Change in Ki-67 With Treatment [ Time Frame: Baseline (Pre-Treatment) and Cycle 2 Day 1, each Cycle is 28 days ]Ki-67 was calculated as a percentage cells staining positive by Immunohistochemistry (IHC).
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): NCT02420691
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Nageshwara V Dasari||M.D. Anderson Cancer Center|