CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Ribociclib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02420691
NCT02420691Phase 2Completed
CompareCT.gov

A Phase II Study of LEE011 (Ribociclib) in Patients With Advanced Neuroendocrine Tumors of Foregut Origin

M.D. Anderson Cancer Center·interventional·Posted Apr 20, 2015·Updated Oct 30, 2020

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Pharmacological Study, and 1 other intervention for Advanced Digestive System Neuroendocrine Neoplasm and 7 related conditions. Completed, enrolled 21 participants across 1 site.

Detailed Summary

This phase II trial studies how well ribociclib works in treating patients with neuroendocrine tumors of the foregut, which includes the thymus, lung, stomach, and pancreas, that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced tumors). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced 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
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Novartis

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 20, 2015
Enrollment StartAug 25, 2015
Primary CompletionJun 5, 2019
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.2 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies

Ribociclibdrug

Given PO