18 and older, any sex, with Advanced Digestive System Neuroendocrine Neoplasm or Duodenal Neuroendocrine Tumor G1. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1Primary· 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.
Group
Value
95% CI
Study Participants
19
Number of Participants With Clinical Benefit RateSecondary· At 6 months
Number of Participants that did not have progressive disease at 6 months.
Group
Value
95% CI
Study Participants
19
Progression Free Survival (PFS)Secondary· 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.
Group
Value
95% CI
Study Participants
10.44
7.37 – 13.49
Change in pRB With TreatmentSecondary· 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.
H- Score Pre-Treatment
Group
Value
95% CI
Study Participants
236.47
± 67.25
H-Score Post-Treatment
Group
Value
95% CI
Study Participants
238.32
± 39.56
Change in Ki-67 With TreatmentSecondary· 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).
Pre-Treatment
Group
Value
95% CI
Study Participants
13.61
± 10.18
Post-Treatment
Group
Value
95% CI
Study Participants
19.11
± 17.83
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 years and 5 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 30 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02420691.